# Patent

## Title
Research study database to compare different research studies and to compare actual activities compared to the protocol

## Abstract

A computer is provided for processing data from a plurality of studies of investigational products in a manner that allows the data from one study to be compared to one or more other studies. Each study includes a plurality of planned activities, a plurality of actual activities, and a plurality of assessments. The computer includes a memory, a database schema and a database. The memory is configured to store an operating system which includes an object-oriented database engine. The database schema is maintained by the object-oriented database engine of the operating system. The database schema has a plurality of uniquely defined database objects. For each study, the uniquely defined database objects include respective sets of objects that store the plurality of planned activities, actual activities, and assessments. The database is populated with data associated with the plurality of planned activities, actual activities, and assessments. The respective sets of objects that store the plurality of planned activities, actual activities, and assessments for each study share common attributes and relationships. Each planned activity, actual activity, and assessment has an associated data type that is the same for different studies.

## Background
CROSS-REFERENCE TO RELATED APPLICATION
This application claims the benefit of U.S. Provisional Patent Application No. 61/377,236 filed Aug. 26, 2010, which is incorporated in its entirety herein.


BACKGROUND OF THE INVENTION
The life of a drug-related patent is normally 20 years from its filing date. However, the drug development process takes around 12-15 years. Thus, the average effective patent life for a new drug—the amount of time where the product is sold under patent protection—is roughly 10 to 12 years. The Drug Price Competition and Patent Term Restoration Act of 1984, also referred to as the “Hatch-Waxman Act,” allows the life of a drug product to be extended to compensate for the delay in obtaining U.S. Food and Drug Administration (FDA) approval, but the extension is limited to five years.
In addition to the direct costs of development, firms must pay returns on the capital that they invest on behalf of shareholders over the course of a decade or more, a cost that increases as development timeframes increase (Masia, Neil. “The Cost of Developing a New Drug.” U.S. DEPARTMENT OF STATE Bureau of International Information Programs, Focus on Intellectual Property Rights, 2006. 82-83).
A report by the Federal Trade Commission has identified the cost of developing a new drug at five million to two billion dollars, with vaccines costing even more (Presentation, Adams, Christopher, Federal Trade Commission. “Spending on New Drug Development”, Jan. 26, 2008, http://www.idei.fr/doc/conf/pha/conf—2008/adams.ppt, retrieved on 1 Apr. 2009). Independently, the Tufts Center for the Study of Drug Development estimates the cost to develop biologic products at $1.2 billion (“Cost to develop new biotech products is estimated to average $1.2 billion”, Tufts Center for the Study of Drug Development Impact Report, Kaitin K I, editor. 2006 November/December; 8(6)). (In the U.S., a biological product is defined as “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product . . . , applicable to the prevention, treatment or cure of a disease or condition of human beings” (Public Health Services Act 42 U.S.C. §262(i)).)
FIG. 29 shows the significant components of the drug development process. After a promising compound has been identified during the process of drug discovery, the development phase begins with the nonclinical phase (animal studies), with goals of determining a compound's probability of success, understanding its potential adverse effects in humans, and determining dosing amounts and delivery methods that will allow safe testing in humans.
After sufficient data has been gathered, a drug company submits an Investigational New Drug Application (IND) to the FDA, providing data showing that it is reasonable to begin tests of a new drug on humans New information is provided to the FDA every month until the drug is approved. New information submitted to the FDA is called a “submission.” There could be over 500 submissions for an IND application. For cancer drugs, on average it takes 8 years from the start of clinical trials (human testing) to approval to market the product.
The Clinical phase of drug development is intended to prove that the drug is safe and effective for its proposed use. If there are existing drugs on the market that are for the same purpose as the investigational new drug, the investigational new drug must provide evidence that it is superior to the already approved drug. For both safety and economic reasons, clinical development takes place over several phases:
Phase 1: Involves the initial introduction of an investigational new drug into humans. These studies are closely monitored and may be conducted in patients, but are usually conducted in healthy volunteer subjects. These studies are designed to determine the initial effect, risks, and, if possible, to gain early evidence on effectiveness. The total number of subjects included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80.
Phase 2: Studies are conducted to obtain some preliminary data on the effectiveness of the drug for a particular purpose (indication) with patients who have the disease or condition. This phase of testing also helps determine the common short-term side effects associated with the drug. Phase 2 studies are typically well-controlled, closely monitored, and conducted in a relatively small number of patients, usually involving several hundred people.
Phase 3: Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase 2, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. Phase 3 studies also provide an adequate basis for extrapolating the results to the general population and transmitting that information in the physician labeling. Phase 3 studies usually include several hundred to several thousand people.
There could be anywhere from several hundred to fewer than one thousand studies performed to show that a product is safe and effective with over a million data points. Each study stores the data points differently, thereby making it extremely difficult to perform analysis across studies and across products. Each study can potentially be run by a different organization and can store and collect data differently.
A clinical trial protocol (protocol) is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. The protocol contains a study plan on which the clinical trial is based. The protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. When analyzing the clinical study data, it can be very difficult and time-consuming to quickly and accurately determine if the protocol was properly followed. The protocol is also referred to herein as the “study definition.”
RELATED PRIOR ART
1. Janus 1
The present invention is based on the goals of the FDA Janus study data repository, described, in part, at the following FDA webpage: http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm155327.htm (all of the above, accessed on Aug. 13, 2010)
The Janus study data repository is being developed by FDA and the National Cancer Institute (NCI) through an Interagency Oncology Task Force (IOTF) that was established in 2003 to enable the two organizations to share knowledge and resources to facilitate the development of new cancer drugs and speed their delivery to patients. As part of the IOTF agreement, FDA is working with NCI to build tools and an environment that facilitates and streamlines electronic interaction and collaboration among FDA and its stakeholders in the regulatory review process. The Janus data repository is part of a larger effort to implement a common, standards-based electronic infrastructure that supports the submission, validation, data warehousing, access, and analysis of clinical and non-clinical study data. SDTM is the standard for the submission of data to the Janus repository.
Phase 1 of the Janus/CRIX project, which included requirements gathering, creation of a prototype environment, and implementation of the Janus module as a proof of concept in the caBIG environment, was completed on Jan. 26, 2006. Phase 2 involved the implementation of an operational pilot that integrated two reviewer tools with the Janus repository. Phase 2 activities (actual activities) included development of a data validation and import facility, loading of validated SDTM datasets into the Janus repository, and creation of analytical views that could be accessed with reviewer analytical and visualization tools.
2. CDISC Study Data Tabulation Model (SDTM)
Study Data Tabulation Model (SDTM, available at http://www.cdisc.org/standards) describes the general conceptual model for representing clinical study data that is submitted to regulatory authorities and the SDTMIG provides specific domain models, assumptions, business rules, and examples for preparing standard tabulation datasets that are based on the SDTM. Domains are tabular listings of information in a study.
3. HL7 Reference Information Model (RIM)
The RIM provides a static view of the information needs of HL7 V3 standards. It includes class and state-machine diagrams and is accompanied by use case models, interaction models, data type models, terminology models, and other types of models to provide a complete view of the requirements and design of HL7 standards. The classes, attributes, state-machines, and relationships in the RIM are used to derive domain-specific information models that are then transformed through a series of constraining refinement processes to eventually yield a static model of the information content of an HL7 standard.
BRIEF SUMMARY OF THE INVENTION
Currently, the FDA and drug development industry spends 30-80% of their time reformatting data to perform analysis. So much time is spent on reformatting the data because each study stores the data differently and there is no a good way to put the data in a common format. The present invention provides a database schema for housing research studies that support research human therapies, veterinary medicine, medical devices and food supplements. The database schema allows for a single database that will house many studies and allow those studies to be analyzed quickly and efficiently. The database allows for comparison studies across different products and the same product. Since data is stored in a uniform manner, the amount of data reformatting is dramatically reduced. The ability to create reusable programs to do certain analysis is possible since the data is stored in a uniformed manner. The database also allows for analysis that compares the protocol to what actually occurred.
DIFFERENCES BETWEEN EMBODIMENTS OF THE PRESENT INVENTION AND THE PRIOR ART
Both Janus 1 and SDTM have a generic method to relate multiple actions. The generic method is to create a group of actions. The group of actions does not have any context, it is just a group. Embodiments of the present invention allows many actions to be related in a meaningful way. A set of observations can be specified to make up an adverse event (which is an actual activity) and the interventions (e.g. substance administrations, procedures) that are the cause can be specified. Both Janus 1 and SDTM do not have a strong link from what actually occurred to what was planned. Janus 1 falls short since there is no direct link to the planned event and SDTM falls short since detail plans (i.e., the schedule of actual activities) are not documented. Neither Janus 1 nor SDTM handle different types of data effectively. Since most data are stored as text, it is hard to compare values. For example, it is hard for a system to determine if the text “two” is greater than the text “1.” Furthermore, it is unclear if “two” is a number. Also, Janus 1 and SDTM do not capture service providers and detailed information about the investigator and ethical committees. Janus 1 does not handle research subjects that are not about a human as a whole.
Since neither Janus 1 nor SDTM can relate to the planned study (i.e., study design and schedule of actual activities) it is impossible to compare what actually occurred in the study to what is planned. Since Janus 1 and SDTM do not uniformly store data, one cannot make observational correlations to determine what therapies work best. Embodiments of the present invention can pull data from multiple studies in a uniform manner that will allow one to make observational correlations to determine what therapies work best.
The HL7's RIM is a generic structure that can be used for healthcare communications. The RIM does not specify any one use and does not specify storage. Accordingly, the RIM cannot be directly used for a specific purpose like the storage and retrieval of clinical data. The RIM is used as a basis for communicated healthcare information.



BRIEF DESCRIPTION OF THE DRAWINGS
Some embodiments of the present invention will now be described by way of example with reference to the accompanying drawings:
FIG. 1: Supplies Entity Relationship Diagram (ERD): How much and when a product is supplied to the research subject.
FIG. 2: Planned Supplies ERD: How much and when a product is planned to be supplied to the research subject. A planned activity can be an elapsed time from another planned activity or treatment.
FIG. 3: Summaries of the Study ERD: Basic characteristics of the study like the blinding or the patient population.
FIG. 4: Planned Substance Administration ERD: The dose, product, route and location of where the substance is planned to be administered and when it will be administered. A planned activity can be an elapsed time from another planned activity or treatment.
FIG. 5: Substance Administration ERD: The dose, product, route and location of where the substance has been administered and when it was administered.
FIG. 6: Study Amendments ERD: All different version of the study including the original and amendments.
FIG. 7: Sites and Service Location ERD: The location of the site and where actual activities are performed, including where the sites are planned to be located or the number of sites planned.
FIG. 8: Service Provider ERD: All of the organization that provide services, their physical locations and sites they are associated with.
FIGS. 9a and 9b: The subject of the research ERD: The subject could be human, living subject that is not a human, a product, a group, or a part/specimen.
FIGS. 10a and 10b: ERD shows the planned research subject including the amount of the research subjects and the actual activities that will be performed.
FIG. 11: Product ERD: Product can have parts, be in a lot, have a dose form, ingredients and with the lots there could have a product instance.
FIG. 12: Planned Procedures ERD: When a procedure is planned to take place, the product plan to be used in the procedure, the specimen planned to be collected, the process to collect the specimen, where the procedure will occur, the method of the procedure. A planned activity can be an elapsed time from another planned activity or treatment.
FIG. 13: Procedures ERD: When a procedure is take place, the product used in the procedure, the specimen collected, the process to collect the specimen, where the procedure occurred, the method of the procedure.
FIG. 14: Organizers ERD: Organizes planned activities or actual activities for analysis and other purposes.
FIG. 15: Planned Observations ERD: When an observation is planned, the method of the observation and where on the subject the observation is planned. A planned activity can be an elapsed time from another planned activity or treatment.
FIG. 16: Observations ERD: When an observation occurred, the method of the observation and where on the subject the observation occurred.
FIG. 17: Reference Range ERD: The range of valid values of the observation from the lab or standard for this observation.
FIG. 18: Investigators ERD: The name and address of the investigator, their qualifications and which study sites they are associated with.
FIG. 19: Study Design and Treatments ERD: The experimental design and schedule of planned activities.
FIG. 20: Evaluations ERD: An evaluation made by a service provider, investigators or device.
FIG. 21: Ethical Committees (IRB) ERD: The ethical committee name and address that approves the study at a site for certain time period and granted at a specific date.
FIG. 22: Eligibility Criteria ERD: The eligibility criteria for a study and how the criteria relate to each other.
FIGS. 23a and 23b: Audit ERD: All actual activities that are performed by the investigator or device.
FIG. 24: Assignment to Treatments ERD: The criteria used and when to check to assign a subject to a treatment.
FIGS. 25a and 25b: Assessments on Observations (Adverse Events) ERD: An assessment or a report of assessments for a subject about observations, causes and results of the assessment, including when the report was completed and available.
FIG. 26: Comparing Actual to Planned Activities ERD: Linking what actually occurred to the planned activity or planned treatment.
FIGS. 27a and 27b: Research Subject and Actual Activities ERD: All actual activities that occur for a research subject, where they occur, when, the duration and when the information was made available.
FIG. 28: Planned Activities in a Treatment ERD: All of the planned activities, including timing, in a specified treatment strategy.
FIG. 29 shows the significant components of the drug development process.
FIG. 30 shows a hardware configuration diagram in accordance with one embodiment of the present invention.
FIG. 31 shows a Process Overview flow diagram of the entire process that is performed by one embodiment of the present invention.



In the figures, the symbol “P” refers to “Primary Key” and the symbol “F” refers to “Foreign Key.”
DETAILED DESCRIPTION OF THE INVENTION
Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. For the purposes of explaining the present invention, specific embodiments will be described. These embodiments are exemplary only, and are not intended to limit the scope of the invention.
In one embodiment, a researcher performs a study to determine if an experimental product is more effective than a placebo. An example of one workflow embodiment is shown in FIG. 31. All steps of the Process Overview are described below. The steps can be done in other order as well. In describing this embodiment, reference is made to the figures and to the tables in the figures. A detailed description of the contents of the tables in the figures is provided below.
An experimental product (FIG. 11) can be used in a study. The product (Table 68: Product) can have ingredients (Table 33: Ingredients); that is, a material (or chemical substance) in the make-up of the main product, not a structural part or content, and not a material added into a device for operation. For medicines and food this is obvious. For devices, an example for ingredient would be latex (Table 67: Product Types) in a chest tube (but not an inhalant in a nebulizer device). Devices also can be known by many identifiers (Table 16: Device Identifier). For example, the manufacturer can have an identifier or manufacturer code and another identifier could be the regulators identifier. The ingredient can be active and have a strength (e.g., 4 mg). The product can be composed of sub products (Table 66: Product Part) and can have a specified dosage form (Table 19: Dosage Form) (e.g., tablet, ointment, gel, etc).
The researcher would design an experiment (FIG. 19). The research would first define the study (Table 101: Study Definition) with a title description and the length of the study. The researcher could choose a simple parallel study that would have two arms (Table 4: Arms) for comparison, the first arm would represent the experimental product and the second arm would represent the placebo. An Arm represents a unique path (of treatments) a subject can take during a study (Table 119: Treatment Arms). Since this is a simple parallel study, there would be three epochs (Table 25: Epochs), the first sequenced epoch would be of a type of screening to ensure only qualified subjects enter the study, the second epoch would be the interventional epoch and the third epoch would be to follow up on the subjects for safety reasons. Epochs are used to compare two or more treatments. Each epoch could have a friendly title and a description. Then the researcher would define treatments (Table 118: Treatments).
A treatment could be organized into smaller parts (Table 121: Sub Treatments). For example, in a cancer study, a treatment could be broken down into a chemotherapy period (treatment) with two different radiation cycles. Since a treatment can be re-used, a treatment is associated with an Arm and Epoch. An example of when a treatment is re-used is in a balanced crossover study where the subjects in different arms receive the same treatments but in different order.
Treatments have a complex workflow (FIG. 24). Treatments have exit and entry criteria and use a workflow control suite of attributes. If there are multiple treatments with the same sequence number, the priority number determines which assignment (Table 7: Assignment) to evaluate first. Before each step, criteria assignments are tested, if applicable. To determine which criteria are applicable, a check point code (Table 13: Check Points) is used. The check point code specifies when in the rules are evaluated (e.g., before the treatment starts for the first time, before every repetition, after each repetition but not before the first, or throughout the entire time of the treatment). If the test is positive, the planned activities have clearance for execution as an actual activity. At that time, the pause quantity timer is started and the actual activities are executed after the pause quantity has elapsed. Pause quantity is allowed to be negative provided that it is possible to predict the occurrence of the target treatment (e.g., administer 3 hours prior to surgery). Treatments can be bound by a specified time period, can iterate in a loop and can have exit and entry criteria (Table 8: Assignment Criteria). The criteria can be a complex set of rules and sub rules of “and” and “or” criteria (Table 14: Conjunction Types). Each criteria can be based on an observation (e.g., male or female; LDL cholesterol above 240 mg/dL). The storage of the observation could be of many data types such as plain text, ratio, and physical quantity (Table 15: Data Types). Entry to a treatment can also be based on randomization. Subjects are assigned to treatments (Table 120: Treatments Planned Subjects).
Data can be stored in many formats, including but not limited to, dates, data ranges, ratios, physical quantities, a range of physical quantities, real, a range of real, string, and coded value. The uses of the data types are documented in the tables. Regarding the coded value (e.g. controlled vocabulary), in many tables (e.g., observation) there are two links to the observation types. One link is for the type of observation (e.g., pain index), the other link is the coded value for the result (e.g., extreme pain).
Now the count and type research subjects are planned (FIGS. 10 and 10b: Planned Research Subject). The planned research subject (Table 56: Planned Research Subject) could by a person, a non-human living subject, a product, a tissue, an organ or part of a person (Table 115: Target Sites), non-human living subject or product (Table 84: Research Subject Types). When the planned subject is living, the species (Table 93: Species) may be noted. There could be relevance to who a subject is related with (Table 59: Planned Subject) and the type of relationship (Table 109: Subject Relationship Types) (e.g., parent, roommate). Experimental units (i.e., subjects) are sometimes segregated and/or assigned to a treatment based on certain criteria (Table 58: Planned Subject Condition). For example, site 1 might enroll 8 males and 12 females, where site 2 enrolls 12 males and 8 females. A planned subject condition is type of observation. Like observation, a planned subject condition can be stored with different data types.
After the experiment is designed, the types of research subjects are defined and treatments are determined, the researcher would create eligibility criteria (FIG. 22). The eligibility criteria (Table 20: Eligibility Criteria) is a complex set of rules to determine if a subject is eligible to participate in the study. Eligibility criteria has the same set of “and’ and “or” criteria as the treatment workflow, and like the treatment workflow, is based on a complex set of observations.
Next, the detailed schedule of planned activities (FIG. 28) is determined. Typically the planned activities are broken by visits or encounters (Table 52: Planned Encounter) with the researcher, but does not have to be. The activities planned to be performed are, collectively, referred to herein as a plurality or set of planned activities and are stored in a set of objects. At the visit, the researcher can supply (Table 60: Planned Supplies) the intervention. The supplied intervention could be a substance administration (Table 51: Planned Administration). The planned intervention could also be a surgery (Table 55: Planned Procedure). During the visit, many observations (Table 54: Planned Observation) occur (e.g., weight, blood pressure). Each planned activity can have a specified duration or can be an offset in time from another planned activity, encounter or treatment. For human clinical trials, case report forms are created at this time.
Planned activities do not have a particular start and stop time. The planned activity starts from an offset (Table 46: Offset Type) of another planned activity, encounter, treatment or the start of the study. For example, an encounter can start on day 13 of a trial, as opposed to January 13th. The offset could be a window (e.g., day 14+−1 day). Planned activities do have a duration that is measured to a specific time unit (Table 116: Time Units) (e.g., seconds).
Planned observations can be complex (FIG. 15). The types of planned observation can be vast (Table 42: Observation Types), from a simple blood pressure to a compound observation like the Barthel Index. The planned observation can be planned to be stored in varied data type including but not limited to, a controlled term, a physical quantity, a ratio, a string, and a numeric value. When the observation is a physical quantity, the quantity has a unit of measure (Table 71: Quantity Units) (e.g., pounds). The observation can be made about a particular location on the subject (Table 115: Target Sites). Observations have different means or techniques used to ascertain the observation (Table 40: Method Types). The observation can be made from a specimen (Table 45: Observation Specimen) collected from the subject. The observation can have qualitative interpretation (Table 34: Interpretation Types); such as abnormal.
Each observation can have a reference range (Table 79: Reference Range). Reference ranges are essentially descriptors of a result values assumed to be “normal”, “abnormal”, or “critical.” Those can vary by sex, age, or any other criterion (Table 77: Reference Range Criteria). The reference range can have a qualitative interpretation and the range may or may not be specific to a lab or facility.
A planned substance administration (FIG. 4) (Table 51: Planned Administration) is a type of procedure that involves a performer introducing or otherwise applying a product (Table 68: Product) into or to the experimental unit. There are many types of substances (Table 2: Administration Types). For purposes of this definition, photons and other models of radiation or light energy are considered substances. Substances may also include living entities such as live virus vaccines and other materials containing infectious agents, e.g., saliva, blood products. There are different routes (Table 88: Routes of Administration) in which a substance can be administered. A substance can be administered to a certain location on the subject (Table 3: Approach Sites). If there are changes to the dose, the reason for that change is recorded.
A planned procedure (FIG. 12) is a planned activity whose immediate and primary outcome (post-condition) is the alteration of the physical condition of the subject. A procedure (Table 55: Planned Procedure) does not comprise all planned activities having an intervention intent. Whether the bodily alteration is appreciated or intended as beneficial to the subject is likewise irrelevant. Taking an x-ray image may sometimes be called “procedure,” but it is not a procedure because an x-ray image is not done to alter the physical condition of the body. The x-ray is a substance administration. There are many different types of procedures (Table 63: Procedure Type). A procedure can approach a specific location (Table 3: Approach Sites) on the subject to target a specific location (Table 115: Target Sites) on the subject. For example, an arteria pulmonalis catheter targets a pulmonary artery, but the approach site is typically the vena carotis interna at the neck or the vena subclavia at the fossa subclavia. There can be different means or technique used to perform the procedure (Table 40: Method Types). The procedure can attach a product or can collect a specimen (Table 57: Planned Specimen). There are many types of specimen (Table 94: Specimen Types) that can be collected (e.g., blood, urine) and there is a process that is followed to collect those specimen (Table 38: Lab Process). There are many types of lab processes (Table 37: Lab Process Types); typical process steps include Specimen Collection, Specimen Accession, and Specimen Separation.
Product or material can be planned to be supplied to subjects (FIG. 2). For example, an investigator provides the subject with a bottle of 20 pills. Most of the detailed information about the supply (Table 60: Planned Supplies) should be represented by the product (Table 68: Product). The quantity (Table 71: Quantity Units) of the supply is needed in the planned supplies table.
When the plan is complete, the research needs to find sites (FIG. 7) where the study will be performed, investigators (FIG. 18) to carry out the study and service providers (FIG. 8) to perform actual activities like a central lab.
The site (Table 92: Sites) is one location where subjects go for treatment. In the planning stage, the site's physical site might not be known. Accordingly, a planning site is documented. A specified time could be documented for the use of the study (Table 102: Study Definition Sites). The site used in the study is commonly known as the study site (Table 98: Study Sites). Sites are not necessarily where treatment happens, but more of an area that can be used for analysis to determine that the intervention had an effect based on the site. Service delivery location (Table 89: Service Delivery Location) is the physical location where treatment occurs.
There could be many investigators (Table 35: Investigators) for a study and the same investigator can perform actual activities for many studies (Table 36: Investigators Studies). An investigator is associated to a study site and must be qualified (Table 70: Qualification) with such things as a degree or certification to be an investigator for the specified study.
Then service providers (Table 90: Service Provider) with certain specialties are chosen for the study (Table 91: Service Provider in Study) in a certain site. The service provider could be a central lab, a data safety monitoring board or something else.
Once the study is designed, treatments are determined, investigators and sites are chosen and service providers are picked, the researcher then will seek independent approval through an institutional review board (IRB) or ethical committee (FIG. 21). The ethical committee (Table 26: Ethical Committee) is a group that approves studies (Table 108: Subject Protection Approval) to be performed on humans. The ethical committee approves the sites, investigators, design, treatments and other documentation. The ethical committee also determines the start and end of the study.
If the experimental product is regulated, the research forwards all of the information about the study (e.g., experimental design, treatments, etc.), ethical committee and participants (e.g., investigator, service provider, sites, etc.) to a regulator. The regulator would also receive summary information (FIG. 3) about the study. The summaries (Table 112: Study Summaries) would include, but are not limited to, the number of subjects, the randomization scheme, the phase of the study, objective, indication, min age of the subject, max age of the subject, and route of administration.
The study begins with the recruitment of research subjects (FIGS. 9a and 9b: Research Subject). The research subject (Table 85: Research Subjects) could by a person, a non-human living subject, a product, a tissue, an organ or part of a person (Table 115: Target Sites), non-human living subject or product (Table 84: Research Subject Types). When the subject is living, the species (Table 93: Species) may be noted. Different organization might have different identifiers for the subject (Table 83: Research Subject); such as, the hospital might have one identifier for the subject and the researcher might have another identifier. There could be relevance to who a subject is related with (Table 110: Subject Cross Table) and the type of relationship (Table 109: Subject Relationship Types) (e.g., parent, roommate). There are some basic demographic information that is of interest about the subject; such as gender (Table 30: Gender), race (Table 72: Race), ethnic group (Table 27: Ethnic Group) and for a product, dosage form (Table 19: Dosage Form).
Next, screening of the subject begins. From the screening it is possible that the study plan will have to change. For example, the eligibility criteria may need to be loosened because patient recruitment is low. An amendment may be needed to the study design (FIG. 6). All of the study design is linked together (Table 106: Study Master). That is, there are different versions of the same study. Each study can also be referred to by a different identifier (Table 105: Study Identifiers). For example, the researcher could have an identification system for studies. When that study is sent to the ethical committee, the ethical committee assigns their own identifier. When the study is sent to a government, the government has their own identifier. Furthermore, the same study can be performed at a different time by a different organization.
When the study is performed at different times, it is considered a different execution of the study (FIG. 7). For each run of a study (Table 103: Study Events), based on the study design, there is a start and end of that study. That study is actually performed at a site (Table 92: Sites) and services (e.g., substance administration, supplies, visits, observations) are delivered at certain locations (Table 97: Study Site Location). Not all service delivery location and sites are specified in the initial study design.
Both the site and the study can be in a different state, including but not limited to recruiting subject, collecting data and analyzing data (Table 99: Study Sites Statues and Table 104: Study Event Statuses). Each status type can have a state, including but not limited to active, closed, complete, and hold. Both statuses are required since one cannot determine the state of the study based on the state of each site. For example, if all of the sites are collecting data, the study can be in the search of a new site and is still in the state of recruiting patients. Each state starts at a specified time and both the site and the study can enter the same state more than once. For example, a site that is closed to recruiting subject can subsequently become open to recruiting subjects again.
The investigator performs actions and collects data (FIGS. 23a and 23b: Audit) on research subjects (FIGS. 27a and 27b: Research Subject Activities). The actions performed and the data collected are, collectively, referred to herein as a plurality or set of actual activities and are stored in a set of objects. These actual activities may or may not occur during an encounter (Table 23: Encounters). Not all encounters are visits. Encounters may include journal entries and phone calls. (Table 22: Encounter Types). Actions have a time that the action occurred and a time that the data was collected. An actual activity or type of data collected could be an observation (Table 43: Observations), substance administration (Table 111: Substance Administration), a supply of product (Table 113: Supplies) and a procedure (Table 64: Procedures).
All actual activities can start and end at a particular time and can have a duration that is measured to a specific time unit (Table 116: Time Units) (e.g., seconds). If an actual activity is modified, the person who modified the record and the reason why they modified the record must be maintained and must point to the old record. Accordingly, each collected data needs an audit trail (FIG. 23a). There are a few standard way to store audit trails. One would be to have one table listing every field that changes. Another way would be to have a shadow table for each table where each table that can be modified would have a duplicate table with extra fields if the action was an insert, delete or edit, the date and time of the action and who did the action. Yet another type would be to list all of the audit trails in one table. The present invention uses this last option. Accordingly, the status (Table 96: Status) table is a lookup to determine the status of any row in a table. The scope of the present invention includes other types of audit trails. The data recording could occur via an investigator, service provider or device (Table 17: Devices).
Observations can be complex (FIG. 16). The types of observation can be vast (Table 42: Observation Types), from a simple blood pressure to a compound observation like the Barthel Index. The observation can be stored in varied data type including, but not limited to, a controlled term (Table 41: Observation Result Types), a physical quantity, a ratio, a string, and a numeric value. When the observation has a physical quantity, the quantity has a unit of measure (Table 71: Quantity Units) (e.g., pounds). The observation can be made about a particular location on the subject (Table 115: Target Sites). Observations have different means or technique used to ascertain the observation (Table 40: Method Types). The observation can be made from a specimen (Table 45: Observation Specimen) collected from the subject. The observation can have qualitative interpretation (Table 34: Interpretation Types) such as “abnormal.”
Each observation can have a reference range (FIG. 17). Reference ranges (Table 79: Reference Range) are essentially descriptors of a result values assumed to be “normal”, “abnormal”, or “critical.” Those can vary by sex, age, or any other criterion (Table 77: Reference Range Criteria). The reference range can have a qualitative interpretation and the range may or may not be specific to a lab or facility.
A substance administration (FIG. 5) (Table 111: Substance Administration) is a type of procedure that involves a performer introducing or otherwise applying a product (Table 68: Product) into or to the experimental unit. There are many types of substances (Table 2: Administration Types). For purposes of this definition, photons and other models of radiation or light energy are considered substances. Substances may also include living entities such as live virus vaccines and other materials containing infectious agents, e.g., saliva, and blood products. There are different routes (Table 88: Routes of Administration) that a substance can be administered. A substance can be administered to a certain location on the subject (Table 3: Approach Sites). If there are changes to the dose, the reason for that change is recorded.
A procedure (FIG. 13) is an actual activity whose immediate and primary outcome (post-condition) is the alteration of the physical condition of the subject. A procedure (Table 64: Procedures) does not comprise all actual activities having an intervention intent. Whether the bodily alteration is appreciated or intended as beneficial to the subject is likewise irrelevant. Taking an x-ray image may sometimes be called “procedure,” but it is not a procedure because an x-ray image is not done to alter the physical condition of the body. The x-ray is a substance administration. There are many different types of procedures (Table 63: Procedure Type). A procedure can approach a specific location (Table 3: Approach Sites) on the subject to target a specific location (Table 115: Target Sites) on the subject. For example: An arteria pulmonalis catheter targets a pulmonary artery, but the approach site is typically the vena carotis interna at the neck or the vena subclavia at the fossa subclavia. There can be different means or technique used to perform the procedure (Table 40: Method Types). The procedure can attach a product or can collect a specimen (Table 95: Specimen). There are many types of specimen (Table 94: Specimen Types) that can be collected (e.g., blood, urine) and there is a process that is followed to collect those specimen (Table 38: Lab Process). There are many types of lab processes (Table 37: Lab Process Types); typical process steps include Specimen Collection, Specimen Accession, and Specimen Separation.
Product or material can be planned to be supplied to subjects (FIG. 1). For example, an investigator provides the subject with a bottle of 20 pills. Most of the detailed information about the supply (Table 113: Supplies) should be represented using by the product. The quantity (Table 71: Quantity Units) of the supply is needed in the supplies table. If a product (Table 65: Product Instance) is administered or supplied, the product could have been produced in a lot (Table 39: Lots). A lot identifies an amount of the product that has been produced or otherwise processed together.
When there is an investigation, assessments (FIGS. 25a and 25b: Assessments on Observations (Adverse Events)) are made. One example of when assessments are made is determining an adverse event. When an adverse event report (Table 81: Reports) is created, source documents (Table 18: Documents) (e.g., doctor's note) are attached to the report (Table 82: Report Documents). The report itself is completed on a certain date and the report is made available on a certain date.
An assessment (Table 5:) is a kind of observation that allows a secondary observation (Table 6: Assessments Observations) to assert (at various levels of probability) the cause (Table 12: Cause) (e.g., substance administration) of the event (actual activity) of a subject. One assessment can have many causes, one per evaluator. Based on the assessment, outcomes are recorded or actions are taken (e.g., stop taking drug) (Table 87: Results). The assessments are, collectively, referred to herein as a plurality or set of assessments and are stored in a set of objects.
Once data is available, analysis can begin. One type of analysis is to compare what actually happened to what was planned to occur (FIG. 26). Each actual activity could be associated with the planned activity, encounter or treatment. An encounter should be associated with a planned encounter. An actual research subject should be associated with a planned research subject. With these associations, an accounting can be provided for all of the actual activities that should have occurred for the planned research subject and match that against what actually occurred. For example, if a physical exam was supposed to occur at an encounter, a check is made to see if that physical exam actually occurred. Furthermore, a comparison can be made between the actual subject observations and the eligibility criteria to determine if the subject was fit for the study. For example, if there is an eligibility criteria that states that all subject must be from the age of 10 to 18, one can calculate that against a subject that has an age of 20.
For analysis purposes, planned and actual activities can be organized (FIG. 14). Organizers (Table 49: Organizers) are used to group a set of planned or actual activities (Table 50: Organizer Actions) sharing a common context. Organizers can nest within other organizers, such as where a document is contained within a folder, or a folder is contained within an Electronic Health Record (HER) extract.
There are many tables that have the word “type” in them. The “type” is a controlled term or lookup table that explains what the main table (e.g., the main table for assignment types is assignment) entry is. For example, an assignment can have the type of randomization or observation. Type tables are one method that can be used to determine the type of row. However, the scope of the present invention includes other methods used to determine the type of row. For example, one might have a check constraint on a table with values for each type. The type could be a number or text.
The following are a list of type tables used in this invention: Table 1: Action Types, Table 2: Administration Types, Table 9: Assignment Observation Types, Table 10: Assignment Types, Table 11: Causes Types, Table 14: Conjunction Types, Table 21: Eligibility Observation Types, Table 22: Encounter Types, Table 24: Epoch Types, Table 28: Evaluator Type, Table 32: Ingredient Types, Table 34: Interpretation Types, Table 37: Lab Process Types, Table 41: Observation Result Types, Table 42: Observation Types, Table 44: Observation Cross Table Types, Table 47: Offset From Type, Table 48: Organizer Types, Table 53: Planned Observation Cross Table Types, Table 61: Planned Subject Condition Observation Type, Table 62: Planned Subject Condition Result Type, Table 63: Procedure Type, Table 69: Qualification Type, Table 73: Reference Criteria Observation Types, Table 76: Reference Observation Types, Table 74: Reference Observation High Type, Table 75: Reference Observation Low Type, Table 78: Reference Range Types, Table 80: Reference Result Code Type, Table 84: Research Subject Types, Table 86: Result Types, Table 94: Specimen Types, Table 100: Study Characteristic Types, Table 107: Study Status Types, Table 109: Subject Relationship Types, Table 114: Supply types and Table 117: Treatment Types.
Many databases handle auto-generated unique identifiers differently. This example does not use built-in database functions to handle auto-generated unique identifiers. This example has a table called identifiers (Table 31: Identifiers) to manage the unique identifier. The table name is the name of the table for the unique identifier and a system queries and adds one to the table to generate a unique identifier. The scope of the present invention includes other types of methods to create unique identifiers, such as using a built-in sequence number in Oracle® or using a combination of unique keys instead of a single primary key.
Different hardware configurations can be used with the present invention. In one example (FIG. 30), several individuals (e.g. statisticians, medical professional, researcher) receive views of the data by querying a database via an electronic network (e.g., the Internet) for information. The individuals may communicate using various forms of data receivers, such as portable computers, handheld computers, and tablet computers. The queries are processed by one or more processors within an application server that communicates with the database server. Each of the processors may be any general-purpose computer, such as a personal computer (PC) that runs a Microsoft Windows® operating system or a mainframe computer running a UNIX-type operating system.
Since many users may simultaneously query for data, the application server may be clustered and/or an application pool may be utilized. Also, since there could be a tremendous amount of stored data, the database can also be clustered. The tables may reside in one or more hard drive. Multiple hard drives may be preferred due to the large amount of data. Furthermore, source clinical data repositories would export data to be stored by the illustrated storage elements.
Referring to FIG. 30, in one preferred embodiment of the present invention, a computer 10 for processing the types of data discussed herein is provided. The computer 10 includes a memory 12 in database server 14 configured to store an operating system 16, a database schema 18, and a database 20. The operating system 16 includes an object-oriented database engine 22. The database schema 18 is maintained by the object-oriented database engine 22 of the operating system 16. The computer 10 also includes memory 24 in application server 26 configured to store an operating system 28 and computer instructions 30 to create, read, update and delete information in the database 20. The computer 10 is in communication with a plurality of data receivers 32 and a source of clinical data 34 via an electronic network 36, such as the internet.
In another embodiment, a computer program product for processing the types of data discussed herein is provided. The computer program product includes non-transitory computer-readable media encoded with instructions for execution by a processor to configure the operating system that includes the object-oriented database engine, maintain the database schema by the object-oriented database engine of the operating system, and maintain the database.
Detailed Description of Tables and Columns
Table 1: Action Types







TABLE 1







Action Types









Table Name
Entity/Column Name
Description





ACTION_TYPES
ENTITY
Either a supply, substance




administration, procedure or




observation.


ACTION_TYPES
ACTION_TYPE_ID
Unique identifier


ACTION_TYPES
DESCRIPITION
Text description of the actions
















TABLE 2







Administration Types









Table Name
Entity/Column Name
Description





ADMINISTRATION_TYPES
ENTITY
The type of administration


ADMINISTRATION_TYPES 
ADMINISTRATION_TYPE_ID
Unique identifier


ADMINISTRATION_TYPES
DESCRIPTION
Friendly name of identifier


ADMINISTRATION_TYPES
CODE
Code from the coding system


ADMINISTRATION_TYPES
CODE_SYSTEM
Code system of the code


ADMINISTRATION_TYPES
CODE_SYSTEM_VERSION
Version of the code system version of




the code
















TABLE 3







Approach Sites










Entity/



Table Name
Column Name
Description





APPROACH_
ENTITY
The anatomical site or system through


SITES

which the procedure reaches its target.




For example: An arteria pulmonalis




catheter targets a pulmonary artery, but




the approach site is typically the vena




carotis interna at the neck or the vena




subclavia at the fossa subclavia.


APPROACH_
APPROACH_
Unique identifier


SITES
SITE_ID



APPROACH_
DESCRIPTION
Friendly name of identifier


SITES




APPROACH_
CODE
Code from the coding system


SITES




APPROACH_
CODE_
Code system of the code


SITES
SYSTEM



APPROACH_
CODE_SYS-
Version of the code system 


SITES
TEM_VERSION
version of the code
















TABLE 4







Arms









Table Name
Entity/Column Name
Description





ARMS
ENTITY
A path through the study which




describes what planned 




activities the subject will be




involved in as they pass 




through the study, and are




typically equivalent to a




treatment group in a parallel




design trial. Generally, each




subject is assigned to an Arm, 




and the design of the study




is reflected in the number and




composition of the individual 




arms. This intended path of




the subject progressing in a trial 




is composed of a time point 




events (study cell) for each 




Epoch of the study. Each 




time point events, in turn, 




has a pattern of child time




points through which




the subject would pass.This 




planned path thus describes 




how subjects assigned to the 




Arm will be treated.


ARMS
ARM_ID
Unique identifier


ARMS
STUDY_DEFINITION_ID
Study definition where the 




arm is defined


ARMS
TITLE
The title of the arm


ARMS
SOURCE_ID
The arm identifier as defined 




in the source document
















TABLE 5







Assessments









Table Name
Entity/Column Name
Description





ASSESSMENTS
ENTITY
A kind of observation 




that allows a Secondary 




Observation (obser-




vation assessment) 




to assert (at various 




levels of probability) 




that the target of 




the association (which 




may be of any type 




of cause) is implicated 




in the etiology of




another observation 




that is named as the 




subject of the Secondary




Observation. The 




assessment is about one 




or more secondary 




observations and what




caused those 




observations.One




assessment can have 




many causes, one per 




evaluator.


ASSESSMENTS
REPORT_ID
The report that contains 




the assessment


ASSESSMENTS
RESEARCH_SUBJECT_ID
The subject of the




assessment


ASSESSMENTS
INVESTIGATOR_ID
If the investigator made 




the assessment


ASSESSMENTS
SERVICE_PROVIDER_ID
If the service provider 




made the assessment


ASSESSMENTS
DEVICE_ID
If the device made the 




assessment


ASSESSMENTS
REASON
The reason for the




assessment


ASSESSMENTS
DATE_EFFECTIVE_HIGH
The date range of when 




the assessment occurred


ASSESSMENTS
DATE_EFFECTIVE_LOW
The date range of when 




the assessment occurred


ASSESSMENTS
DURATION
The duration of the




assessment


ASSESSMENTS
DURATION_TIME_UNIT_ID
The duration of the 




assessment


ASSESSMENTS
SOURCE_ID
Source identifier of the 




assessment


ASSESSMENTS
EVALUATOR_TYPE_ID
Who made the 




assessment (e.g. 




patient, drug company, 




investigator, device, 




service provider, etc.)
















TABLE 6







Assessments Observations










Entity/ 



Table Name
Column Name
Description





ASSESSMENTS_OBSERVATIONS
ENTITY
One observation 




can be referred to 




in many assess- 




ments and an 




assessment can be 




based on many 




observations.
















TABLE 7







Assignment









Table Name
Entity/Column Name
Description





ASSIGNMENT
ENTITY
Treatments have exit 




and entry criteria and 




uses workflow control 




suite of attributes.


ASSIGNMENT
ASSIGNMENT_ID
Unique identifier


ASSIGNMENT
ASSIGNMENT_TYPE_ID
If the assignment is 




based on random-




ization or observation


ASSIGNMENT
TREATMENT_ID
The treatment


ASSIGNMENT
DESCRIPTION
The textual description 




of the assignment
















TABLE 8







Assignment Criteria









Table Name
Entity/Column Name
Description





ASSIGNMENT_CRITERIA
ENTITY
Each assignment has criteria to




determine if the assignment will be




executed


ASSIGNMENT_CRITERIA
ASSIGNMENT_CRITERION_ID
Unique identifier


ASSIGNMENT_CRITERIA
ASSIGNMENT_ID
The assignment


ASSIGNMENT_CRITERIA
PARENT_ID
If the criteria is completes the parent




criteria


ASSIGNMENT_CRITERIA
CONJUNCTION_TYPE_ID
The logical conjunction of the criteria 




among all the rules (e.g., and, or,




exclusive-or).


ASSIGNMENT_CRITERIA
RESULT_REAL
Used when the data type is physical 




quantity, ratio or real. Result is a




numeric value of the observation


ASSIGNMENT_CRITERIA
RESULT_UNIT_ID
Used when the data type is physical 




quantity or ratio. The unit of measure 




of the result. The numeric value will be 




located in the result_real. 


ASSIGNMENT_CRITERIA
RESULT_STRING
Used when the data type is string. The 




result of the observation 


ASSIGNMENT_CRITERIA
RESULT_DATE_LOW
Used when the data type is date. The 




result of the observation


ASSIGNMENT_CRITERIA
RESULT_DATE_HIGH
Used when the data type is date. The 




result of the observation


ASSIGNMENT_CRITERIA
RESULT_DENOM_REAL
Used when the data type is ratio. The 




numeric denominator result of the




operation


ASSIGNMENT_CRITERIA
RESULT_DENOM_UNIT_ID
Used when the data type is ration. The 




unit of measure of the denominator of 




the result of the observation


ASSIGNMENT_CRITERIA
NEGATION
Explains the results are the opposite of 




what is stated


ASSIGNMENT_CRITERIA
SEQ
The order of the child criteria
















TABLE 9







Assignment Observation Types










Entity/




Column 



Table Name
Name
Description





ASSIGNMENT_OBSERVATION_TYPES
ENTITY
The type of observation in coded




values. Since coded systems 




can be post-coordinate, many 




codes could be present


ASSIGNMENT_OBSERVATION_TYPES
SEQ
The order the code appeared 




in the observation


ASSIGNMENT_RESULTS_OBS_TYPES
ENTITY
The type of observation in coded




values. Since coded systems 




can be post-coordinate, many 




codes could be present


ASSIGNMENT_RESULTS_OBS_TYPES
SEQ
The order the code appeared 




in the observation
















TABLE 10







Assignment Types









Table Name
Entity/Column Name
Description





ASSIGNMENT_TYPES
ENTITY
If the assignment 




is based on




randomization 




or observation


ASSIGNMENT_TYPES
ASSIGNMENT_TYPE_ID
Unique identifier


ASSIGNMENT_TYPES
DESCRIPTION
Friendly name 




of identifier


ASSIGNMENT_TYPES
CODE
Code from the 




coding system


ASSIGNMENT_TYPES
CODE_SYSTEM
Code system of 




the code


ASSIGNMENT_TYPES
CODE_SYSTEM_VERSION
Version of the 




code system 




version of the 




code
















TABLE 11







Causes Types









Table Name
Entity/Column Name
Description





CAUSE_TYPES
ENTITY
The type of cause




(e.g., need examples)


CAUSE_TYPES
CAUSE_TYPE_ID
Unique identifier


CAUSE_TYPES
CODE
Code from the coding 




system


CAUSE_TYPES
CODE_SYSTEM
Code system of the code


CAUSE_TYPES
CODE_SYSTEM_VERSION
Version of the code 




system version of




the code


CAUSE_TYPES
DESCRIPTION
Friendly name of




identifier
















TABLE 12







Cause










Entity/Column 



Table Name
Name
Description





CAUSES
ENTITY 
A kind of observation that allows a




Secondary Observation (source act) to




assert (at various levels of probability)




that the target act of the association




(which may be of any type of act) is




implicated in the etiology of another




observation that is named as the subject




of the Secondary Observation
















TABLE 13







Check Points









Table Name
Entity/Column Name
Description





CHECK_POINTS
ENTITY
A code specifying when 




in the rules are evaluated




(e.g., before the treat- 




ment starts for the




first time, before every 




repetition, after each 




repetition but not 




before the first, or




throughout the entire




time of the treatment.)


CHECK_POINTS
CHECK_POINT_ID
Unique Identifier


CHECK_POINTS
DESCRIPTION
Friendly name of 




identifier


CHECK_POINTS
CODE
Code from the coding 




system


CHECK_POINTS
CODE_SYSTEM
Code system of the code


CHECK_POINTS
CODE_SYSTEM_VERSION
Version of the code 




system version of




the code
















TABLE 14







Conjunction Types









Table Name
Entity/Column Name
Description





CONJUNCTION_TYPES
ENTITY
The logical 




conjunction of




the criteria 




among all the 




rules


CONJUNCTION_TYPES
CONJUNCTION_TYPE_ID
Unique identifier


CONJUNCTION_TYPES
DESCRIPTION
Friendly name of 




identifier


CONJUNCTION_TYPES
CODE
Code from the 




coding system


CONJUNCTION_TYPES
CODE_SYSTEM
Code system of 




the code


CONJUNCTION_TYPES
CODE_SYSTEM_VERSION
Version of the 




code system 




version of




the code
















TABLE 15







Data Types









Table Name
Entity/Column Name 
Description





DATATYPES
ENTITY
The type of data (e.g., physical




quantity, real, string, coded) 




that will be used


DATATYPES
DATATYPE_ID
Unique Identifier


DATATYPES
DESCRIPTION
Friendly name of identifier
















TABLE 16







Device Identifier










Entity/Column 



Table Name
Name
Description





DEVICE_IDENTIFIER
ENTITY
Unique identifier of the device
















TABLE 17







Devices









Table Name
Entity/Column Name
Description





DEVICES
ENTITY
A device that is a data enterer. One




device can be used on many studied


DEVICES
DEVICE_ID
Unique identifier


DEVICES
MODEL_NUMBER
The human designated moniker for




a device, assigned by the 




manufacturer.


DEVICES
SOFTWARE_NAME
The moniker, version and release




of the software that operates 




the device as assigned by the




software manufacturer or developer.
















TABLE 18







Documents









Table Name
Entity/Column Name
Description





DOCUMENTS
ENTITY
There could be several 




documents in a report


DOCUMENTS
DOCUMENT_ID
Unique identifier


DOCUMENTS
URL
Location of the document
















TABLE 19







Dosage Form









Table Name
Entity/Column Name
Description





DOSAGE_FORMS
ENTITY
such as tablet, ointment, gel, etc


DOSAGE_FORMS
DOSAGE_FORM_ID
Unique identifier


DOSAGE_FORMS
DESCRIPTION
Friendly name of identifier


DOSAGE_FORMS
CODE
Code from the coding system


DOSAGE_FORMS
CODE_SYSTEM
Code system of the code


DOSAGE_FORMS
CODE_SYSTEM_VERSION
Version of the code system version of the code
















TABLE 20







Eligibility Criteria









Table Name
Entity/Column Name
Description





ELIGIBILITY_CRITERIA
ENTITY
Eligibility criteria are a set of




conditions that a subject must meet in




order to participate in a study.




Because eligibility criteria affect




recruitment into a study, they are often




the subject of protocol amendments,




and one criterion may be superseded by




another. The most commonly occurring




types of criteria involve age, sex, the




type and stage of a disease, treatment




history, and other medical conditions.




For a full description of how conditions




work review the Condition section.


ELIGIBILITY_CRITERIA
STUDY_DEFINITION_ID
The study that defines the eligibility




criteria


ELIGIBILITY_CRITERIA
PARENT_ID
If the criteria is complex (e.g., (A AND




B) OR (C AND D)) the parent id is the




criteria identifier of this sub rule


ELIGIBILITY_CRITERIA
CONJUNCTION_TYPE_ID
The logical conjunction of the criteria




among all the criteria (e.g., and, or,




exclusive-or).


ELIGIBILITY_CRITERIA
DATATYPE_ID
The type of data (e.g., physical




quantity, real, string, coded) that will be




used in the criteria


ELIGIBILITY_CRITERIA
RESULT_REAL
Only used if data type is a physical




quantity, ratio, or real. Value of the




criteria.


ELIGIBILITY_CRITERIA
RESULT_UNIT_ID
Only used if data type is a physical




quantity or ratio. Unit of measure of the




value of the criteria.


ELIGIBILITY_CRITERIA
RESULT_STRING
Only used if data type is a string. Value




of the criteria.


ELIGIBILITY_CRITERIA
RESULT_DATE_LOW
Only used if data type is a date. Value




of the criteria.


ELIGIBILITY_CRITERIA
RESULT_DATE_HIGH
Only used if data type is a date. Value




of the criteria.


ELIGIBILITY_CRITERIA
RESULT_DENOM_REAL
Only used if data type is a ratio. Value




of the denominator rule.


ELIGIBILITY_CRITERIA
RESULT_DENOM_UNIT_ID
Only used if data type is a ratio. Unit of




measure of the denominator of the




value of the rule.


ELIGIBILITY_CRITERIA
NEGATION
The criteria is the opposite (e.g., if the




code is fever, then when negation is set




to true, the criteria will be absent of




fever).


ELIGIBILITY_CRITERIA
DESCRIPTION
The full textual description of the




criteria


ELIGIBILITY_CRITERIA
SOURCE_ID
The identifier in the source document
















TABLE 21







Eligibility Observation Types










Entity/



Table Name
Column Name
Description





ELIGIBILITY_OBSERVATION_TYPES
ENTITY
The type of observation in coded




values. Since coded systems can be




post-coordinate, many codes could be




present


ELIGIBILITY_OBSERVATION_TYPES
SEQ
The order the code appeared in the




observation


ELIGIBILITY_RESULTS_OBS_TYPES
ENTITY
The type of observation in coded




values. Since coded systems can be




post-coordinate, many codes could be




present


ELIGIBILITY_RESULTS_OBS_TYPES
SEQ
The order the code appeared in the




observation
















TABLE 22







Encounter Types









Table Name
Entity/Column Name
Description





ENCOUNTER_TYPES
ENTITY
The types of encounter (e.g., visit,




journal, phone call)


ENCOUNTER_TYPES
ENCOUNTER_TYPE_ID
Unique identifier


ENCOUNTER_TYPES
DESCRIPTION
Friendly name of identifier


ENCOUNTER_TYPES
CODE
Code of the encounter


ENCOUNTER_TYPES
CODE_SYSTEM
Code system of the code


ENCOUNTER_TYPES
CODE_SYSTEM_VERSION
Version of the code system version of




the code
















TABLE 23







Encounters










Entity/



Table Name
Column Name
Description





ENCOUNTERS
ENTITY
An interaction between an experimental




unit and an investigator for the purpose




of providing study related services.


ENCOUNTERS
ENCOUNTER_ID
Unique identifier


ENCOUNTERS
ENCOUNTER_TYPE_ID
The type of encounter (e.g., visit,




journal entry).


ENCOUNTERS
RESEARCH_SUBJECT_ID
The encounter is unique based on




research subject and unique identifier.


ENCOUNTERS
DESCRIPTION
Textual description of the encounter


ENCOUNTERS
DATE_EFFECTIVE_HIGH
Start date and time of encounter.


ENCOUNTERS
DATE_EFFECTIVE_LOW
End date and time of encounter


ENCOUNTERS
AVAILABLE_DATE
The point in time at which information




about this encounter first became




available to a system reproducing this




encounter. The availability date is




metadata describing the record, not the




encounter.


ENCOUNTERS
DURATION
The magnitude of the quantity




measured in terms of the unit of the




duration


ENCOUNTERS
DURATION_TIME_UNIT_ID
The unit of measure specified for the




duration


ENCOUNTERS
PLANNED_ENCOUNTER_ID
Link to the planned encounter


ENCOUNTERS
TREATMENT_ID
The treatment that this encounter is




within


ENCOUNTERS
IS_CURRENT
If true the this record is the most




current


ENCOUNTERS
MODIFIED_REASON
The reason for the modification


ENCOUNTERS
MODIFIED_ENCOUTNER_ID
The encounter records that this records




modifies


ENCOUNTERS
MODIFIED_RESEARCH_SUBJECT_ID
The encounter record that this record




modifies
















TABLE 24







Epoch Types










Entity/



Table Name
Column Name
Description





EPOCH_TYPES
ENTITY
A coded value which indicates 




the general scope of the planned




activities that occurin the epoch.




Forexample, screening, treatment,




follow-up, etc.


EPOCH_TYPES
EPOCH_TYPE_ID
Unique identifier


EPOCH_TYPES
TITLE
The description of the type of




epoch
















TABLE 25







Epochs









Table 
Entity/



Name
Column Name
Description





EPOCHS
ENTITY
A subject moves from one Epoch to another and can only be in one epoch at a time. 




The subject can only move to an Epoch with a greater sequenceNumber. The main




purpose of the Epoch is to organize the Arms for comparison purposes. Planned




activities in the same Epoch but a different Arm need not be similar in time and




pattern.


EPOCHS
EPOCH_ID
Unique identifier


EPOCHS
STUDY_DEFINITION_ID
The study definition that defines the epoch


EPOCHS
EPOCH_TYPE_ID
A coded value which indicates the general scope of the planned activities that occur




in the epoch. For example, screening, treatment, follow-up, etc.


EPOCHS
TITLE
The protocol-assigned name for an epoch.




Note: When multiple Epochs have the same purpose (e.g., treatment), then the




titles will probably include order numbers to distinguish them. For example, first




treatment epoch, second treatment epoch, etc. or first wash-out epoch, second




wash-out epoch.


EPOCHS
SEQUENCE
The order the epochs are executed


EPOCHS
DESCRIPTION
Human readable text which describes what happens to the subject during the epoch.


EPOCHS
SOURCE_ID
The identifier in the source document
















TABLE 26







Ethical Committee









Table Name
Entity/Column Name
Description





ETHICAL_COMMITTEES
ENTITY
A board that approves monitors and




reviews biomedical research to protect




the rights, safety and welfare of the




subjects. An Ethical Committee




performs critical oversight functions for




research conducted on human subjects




that are scientific, ethical, and




regulatory.


ETHICAL_COMMITTEES
ETHICAL_ COMMITTEE_ID
Unique identifier
















TABLE 27







Ethnic Group











Table Name
Entity/Column Name
Description







ETHNIC_GROUPS
ENTITY
The ethnic group

















TABLE 28







Evaluator Type









Table Name
Entity/Column Name
Description





EVALUATOR_TYPES
ENTITY
The type of the evaluator 




(e.g., investigator)
















TABLE 29







Gender Status









Table Name
Entity/Column Name
Description





GENDER_STATUSES
ENTITY
The status of the gender
















TABLE 30







Gender











Table Name
Entity/Column Name
Description







GENDERS
ENTITY
The gender

















TABLE 31







Identifiers









Table Name
Entity/Column Name
Description





ID_REFS
ENTITY
To handle unique ids
















TABLE 32







Ingredient Types









Table Name
Entity/Column Name
Description





INGREDIENT_TYPES
ENTITY
The kind of the 




ingredient


INGREDIENT_TYPES
INGREDIENT_TYPE_ID
Unique identifier


INGREDIENT_TYPES
CODE
Code from the 




coding system


INGREDIENT_TYPES
CODE_SYSTEM
Code system of the 




code


INGREDIENT_TYPES
CODE_SYSTEM_VERSION
Version of the code 




system version of 




the code


INGREDIENT_TYPES
ESTABLISHED_NAME
Friendly name of 




identifier
















TABLE 33







Ingredients









Table Name
Entity/Column Name
Description





INGREDIENTS
ENTITY
A material (or chemical substance) in




the make-up of the main product, not a




structural part or content, and not a




material added into a device for




operation. For medicines and food this




is obvious. For devices, an example for




ingredient would be latex in a chest




tube (but not an inhalant in a nebulizer




device).


INGREDIENTS
INGREDIENT_ID
Unique identifier


INGREDIENTS
INGREDIENT_TYPE_ID
The code for an ingredient from a




controlled vocabulary (e.g., the U.S.




FDA UNII code).


INGREDIENTS
PRODUCT_ID
The product the ingredient is within


INGREDIENTS
ACTIVE
Whether the ingredient is active or




inactive


INGREDIENTS
STRENGTH_NUMERATOR
A ratio specifying the strength of the




ingredient as amount of ingredient




substance (numerator) in amount of




medicine (denominator). For example,




a 50 mg tablet contains 50 mg in 1




tablet; a 50 mg per 5 mL syrup contains




50 mg in 5 mL.


INGREDIENTS
NUMERATOR_UNIT_ID
Unit of measure of the strength


INGREDIENTS
STRENGTH_DENOMERATOR
Strength in the denominator


INGREDIENTS
DENOMERATOR_UNIT_ID
Unit of measure of the strength


INGREDIENTS
CONFIDENTIAL
Is the ingredient confidential


INGREDIENTS
NAME
Name of the ingredient


INGREDIENTS
SOURCE_ID
The identifier in the source document
















TABLE 34







Interpretation Types









Table Name
Entity/Column Name
Description





INTERPRETATION_TYPES
ENTITY
A qualitative interpretation of the




observation. These interpretation codes




are sometimes called “abnormal flags,”




however, the judgment of normalcy is




just one of the interpretations, and is




often not relevant.


INTERPRETATION_TYPES
INTERPRETATION_TYPE_ID
Unique identifier


INTERPRETATION_TYPES
DESCRIPTION
Friendly name of identifier


INTERPRETATION_TYPES
CODE
Code from the coding system


INTERPRETATION_TYPES
CODE_SYSTEM
Code system of the code


INTERPRETATION_TYPES
CODE_SYSTEM_VERSION
Version of the code system version of




the code
















TABLE 35:







Investigators









Table 




Name
Entity/Column Name
Description





INVESTI-
ENTITY
A researcher in a study who oversees


GATORS

aspects of the study, such as concept




development, protocol writing, protocol




submission for IRB approval,




participant recruitment, informed




consent, data collection, analysis,




interpretation and presentation. A study




can have one study primary




investigator, although this is not




required. There is one site primary




investigator for each site for a study.




There could be many sub-investigators




for a study site. One investigator can be




on several studies


INVESTI-
INVESTIGATOR_ID
Unique identifier


GATORS
















TABLE 36







Investigators Studies









Table Name
Entity/Column Name
Description





INVESTIGATORS_STUDIES
ENTITY
The investigator on the study.


INVESTIGATORS_STUDIES
INVESTIGATOR_STUDY_ID
Unique identifier


INVESTIGATORS_STUDIES
INVESTIGATOR_ID
The investigator


INVESTIGATORS_STUDIES
INVESTIGATOR_TYPE_ID
If the investigator is the primary or sub




on this study


INVESTIGATORS_STUDIES
SITE_ID
The site the investigator.


INVESTIGATORS_STUDIES
STUDY_MASTER_ID
the study


INVESTIGATORS_STUDIES
DATE_LOW
The start of actual activities for the




investigator


INVESTIGATORS_STUDIES
DATE_HIGH
The end of actual activities for the




investigator
















TABLE 37







Lab Process Types









Table Name
Entity/Column Name
Description





LAB_PROCESS_TYPES
ENTITY
The type of lab process (Typical




process steps are Specimen Collection,




Specimen Accession, Specimen




Separation etc)


LAB_PROCESS_TYPES
LAB_PROCESS_TYPE_ID
Unique identifier


LAB_PROCESS_TYPES
DESCRIPTION
Friendly name of identifier


LAB_PROCESS_TYPES
CODE
Code from the coding system


LAB_PROCESS_TYPES
CODE_SYSTEM
Code system of the code


LAB_PROCESS_TYPES
CODE_SYSTEM_VERSION
Version of the code system version of




the code
















TABLE 38







Lab Process









Table Name
Entity/Column Name
Description





LAB_PROCESSES
ENTITY
A process is performed on a specimen




and its container or holder. Typical




process steps are Specimen Collection,




Specimen Accession, and Specimen




Separation etc. The Process Step is




intended to identify that the step has




taken place but not record any value or




the outcome. For instance, when Cold




Agglutinins are discovered in the




specimen during the processing of a




CBC test the specimen is placed in a 37




degree wash for two hours. This




observation would record that this had




been performed.


LAB_PROCESSES
LAB_PROCESS_ID
Unique identifier


LAB_PROCESSES
LAB_PROCESS_TYPE_ID
The type of lab process (Typical




process steps are Specimen Collection,




Specimen Accession, Specimen




Separation etc)


LAB_PROCESSES
SPECIMEN_ID
The specimen


LAB_PROCESSES
PLANNED_SPECIMEN_ID
The planned specimen


LAB_PROCESSES
DESCRIPTION
Text description of the process


LAB_PROCESSES
DATE_EFFECTIVE_LOW
When the process took place


LAB_PROCESSES
DATE_EFFECTIVE_HIGH
When the process took place
















TABLE 39







Lots









Table




Name
Entity/Column Name
Description





LOTS
ENTITY
The lot for this instance. It identifies an




amount of the product that has been




produced or otherwise processed




together.


LOTS
LOT_ID
Unique Identifier


LOTS
PRODUCT_ID
The product


LOTS
LOT_NUMBER
The lot number for this instance.


LOTS
EXPIRATION_LOW
When the lot expires


LOTS
EXPERATION_HIGH
When the lot expires
















TABLE 40







Method Types









Table Name
Entity/Column Name
Description





METHOD_TYPES
ENTITY
The means or technique used to




ascertain the observation. In all




observations the method is already




partially specified by the observation




type. In this case, the methodCode need




not be used at all. Examples: Blood




pressure measurement method: arterial




puncture vs. sphygmomanometer




(Riva-Rocci), sitting vs. supine position


METHOD_TYPES
METHOD_TYPE_ID
Unique identifier


METHOD_TYPES
DESCRIPTION
Friendly name of identifier


METHOD_TYPES
CODE
Code from the coding system


METHOD_TYPES
CODE_SYSTEM
Code system of the code


METHOD_TYPES
CODE_SYSTEM_VERSION
Version of the code system version of




the code
















TABLE 41







Observation Result Types









Table Name
Entity/Column Name
Description





OBSERVATION_RESULT_CODE_TYPES
ENTITY
Results of the observation for coded




values. Since coded systems can be




post-coordinate, many codes could be




present
















TABLE 42







Observation Types









Table Name
Entity/Column Name
Description





OBSERVATION_TYPES
ENTITY
The type of observation (e.g., type of




lab test)


OBSERVATION_TYPES
OBSERVATION_TYPE_ID
Unique identifier


OBSERVATION_TYPES
DESCRIPTION
Friendly name of identifier


OBSERVATION_TYPES
CODE
Code from the coding system


OBSERVATION_TYPES
CODE_SYSTEM
Code system of the code


OBSERVATION_TYPES
CODE_SYSTEM_VERSION
Version of the code system version of




the code


OBSERVATION_TYPES
DATATYPE_ID
The data type expected for the result of




this observation.
















TABLE 43







Observations









Table Name
Entity/Column Name
Description





OBSERVATIONS
ENTITY
An actual activity that is intended to




result in new information about a




subject. A description of what was




actually observed (“results” or




“answers”). It may be a


OBSERVATIONS
OBSERVATION_ID
Unique identifier


OBSERVATIONS
METHOD_TYPE_ID
The means or technique used to




ascertain the observation. In all




observations the method is already




partially specified by the observation




type. In this case, the methodCode need




not be used at all. Examples: Blood




pressure measurement method: arterial




puncture vs. sphygmomanometer




(Riva-Rocci), sitting vs. supine position


OBSERVATIONS
INTERPRETATION_TYPE_ID
A qualitative interpretation of the




observation. These interpretation codes




are sometimes called “abnormal flags,”




however, the judgment of normalcy is




just one of the interpretations, and is




often not relevant.


OBSERVATIONS
ENCOUNTER_ID
The encounter where the observation




occurred


OBSERVATIONS
TARGET_SITE_ID
The anatomical site or system that is




the focus of the observation. Most




observation target sites are implied by




the observation type. For example,




“heart murmur” always has the heart as




target. If the subject of the Observation




is something other than a human patient




or animal, the attribute is used




analogously to specify a structural




landmark of the thing where the




observation focuses.


OBSERVATIONS
DATATYPE_ID
Based on the data type certain fields




will be populated. The data type




examples include, coded, physical




quantity, string, real


OBSERVATIONS
RESULT_REAL
Used when the data type is physical




quantity, ratio or real. Result in a




numeric value of the observation


OBSERVATIONS
RESULT_UNIT_ID
Used when the data type is physical




quantity or ratio. The unit of measure




of the result. The numeric value will be




located in the result real.


OBSERVATIONS
RESULT_STRING
Used when the data type is string. The




result of the observation


OBSERVATIONS
RESULT_DATE_LOW
Used when the data type is date. The




result of the observation


OBSERVATIONS
RESULT_DATE_HIGH
Used when the data type is date. The




result of the observation


OBSERVATIONS
RESULT_DENOM_REAL
Used when the data type is ratio. The




numeric denominator result of the




operation


OBSERVATIONS
RESULT_DENOM_UNIT_ID
Used when the data type is ration. The




unit of measure of the denominator of




the result of the observation


OBSERVATIONS
NEGATION
Explains the results are the opposite of




what is stated


OBSERVATIONS
DESCRIPTION
Textual description of the observation


OBSERVATIONS
DATE_EFFECTIVE_HIGH
The date the observation was taken


OBSERVATIONS
DATE_EFFECTIVE_LOW
The date the observation was taken


OBSERVATIONS
DURATION
The magnitude of the quantity




measured in terms of the unit of the




duration


OBSERVATIONS
DURATION_TIME_UNIT_ID
The unit of measure specified for the




duration


OBSERVATIONS
AVAILABLE_DATE
The point in time at which information




about this observation first became




available to a system reproducing this




observation. The availability date is




metadata describing the record, not the




observation.


OBSERVATIONS
SOURCE_ID
The id provided by the source




document


OBSERVATIONS
BASELINE
Is this observation a baseline




observation


OBSERVATIONS
OBSERVATION_TYPE_SOURCE
Original text of the type of observation




(e.g., blood pressure test)


OBSERVATIONS
RESULT_SOURCE
Original text of the result


OBSERVATIONS
RESULT_SOURCE_UNIT
Original text of the result unit


OBSERVATIONS
RESEARCH_SUBJECT_ID
The subject of the observation


OBSERVATIONS
DATA_ENTERER
The person who entered the data


OBSERVATIONS
MODIFIED_REASON
The reason for the modification


OBSERVATIONS
MODIFIED_OBSERVATION_ID
The observation records that this




records modifies


OBSERVATIONS
DEVICE_ID
The device that recorded the




observation


OBSERVATIONS
INVESTIGATOR_ID
The investigator that recorded the




observation


OBSERVATIONS
SERVICE_PROVIDER_ID
The service provided that recorded the




observation


OBSERVATIONS
PLANNED_OBSERVATION_ID
The planned observation as specified in




the protocol


OBSERVATIONS
TREATMENT_ID
The treatment that this observation is




within


OBSERVATIONS
IS_CURRENT
If true the this record is the most




current
















TABLE 44







Observation Cross Table Types









Table Name
Entity/Column Name
Description





OBSERVATIONS_OBSERVATION_TYPES
ENTITY
The type of observation in coded




values. Since coded systems can be




post-coordinate, many codes could be




present


OBSERVATIONS_OBSERVATION_TYPES

The order the code appeared in the


SEQ

observation
















TABLE 45







Observation Specimen









Table Name
Entity/Column Name
Description





OBSERVATIONS_SPECIMENS
ENTITY
One specimen can be the focus of many




observations


OBSERVATIONS_SPECIMENS
CONDITION
The condition of the specimen. For




example, if the specimen is cloudy, that




could be analytically significant
















TABLE 46







Offset Type









Table Name
Entity/Column Name
Description





OFFSET_BEFORE_AFTER_TYPES
ENTITY
A relationship in which the target




planned activity takes place with a




defined temporal relationship with




respect to this planned activity. The




relationship could be offset from the




start or end of the target planned




activity
















TABLE 47







Offset From Type









Table Name
Entity/Column Name
Description





OFFSET_FROM_TYPES
ENTITY
The type of 




planned activity 




to offset from 




(e.g., treatment,




procedure, 




supply, etc.)


OFFSET_FROM_TYPES
OFFSET_FROM_TYPE_ID
Unique identifier


OFFSET_FROM_TYPES
DESCRIPTION
Friendly name 




of the type
















TABLE 48







Organizer Types









Table Name
Entity/Column Name
Description





ORGANIZER_TYPES
ENTITY
The type of 




organizer (e.g. 




domain, demo-




graphic, lab 




tests, etc.)


ORGANIZER_TYPES
ORGANIZER_TYPE_ID
Unique identifier


ORGANIZER_TYPES
DESCRIPTION
Friendly name 




of identifier


ORGANIZER_TYPES
CODE
Code from the 




coding system


ORGANIZER_TYPES
CODE_SYSTEM
Code system of 




the code


ORGANIZER_TYPES
CODE_SYSTEM_VERSION
Version of the 




code system ver-




sion of the code
















TABLE 49







Organizers









Table Name
Entity/Column Name
Description





ORGANIZERS
ENTITY
Used to group a set of planned 




or actual activities sharing a 




common context.




Organizers can nest within other




organizers - such as where a




document is contained within a 




folder, or a folder is contained 




within an EHR extract


ORGANIZERS
ORGANIZER_ID
Unique identifier


ORGANIZERS
ORGANIZER_TYPE_ID
The type of organizer


ORGANIZERS
DESCRIPTION
The description of the organizer


ORGANIZERS
SOURCE_ID
The identifier of the organizer 




from the source document
















TABLE 50







Organizer Actions









Table Name
Entity/Column Name
Description





ORGANIZERS_ACTIONS
ENTITY
Link many planned or actual 




activities in to one organizer


ORGANIZERS_ACTIONS
ORGANIZER_ACTION_ID
Unique identifier


ORGANIZERS_ACTIONS
ORGANIZER_ID
The organizer


ORGANIZERS_ACTIONS
ACTION_TYPE_ID
A supply, substance administration,




procedure or observation.
















TABLE 51







Planned Administration









Table Name
Entity/Column Name
Description





PLANNED_ADMINISTRATIONS
ENTITY
A planned type of procedure that




involves a performer introducing or




otherwise applying a product into or to




the experimental unit. For purposes of




this definition, photons and other




models of radiation or light energy are




considered substances. Substances may




also include living entities such as live




virus vaccines and other materials




containing infectious agents, e.g.,




saliva, blood products, etc.


PLANNED_ADMINISTRATIONS
OFFSET_OBSERVATION_ID
Offset from a target observation
















TABLE 52







Planned Encounter









Table Name
Entity/Column Name
Description





PLANNED_ENCOUNTERS
ENTITY
A planned interaction between an




experimental unit and an investigator




for the purpose of providing study




related services.


PLANNED_ENCOUNTERS
PLANNED_ENCOUNTER_ID
Unique identifier


PLANNED_ENCOUNTERS
ENCOUNTER_TYPE_ID
The type of encounter (e.g., visit,




journal entry).


PLANNED_ENCOUNTERS
DESCRIPTION
Textual description of the encounter


PLANNED_ENCOUNTERS
DURATION
The magnitude of the quantity




measured in terms of the unit of the




duration


PLANNED_ENCOUNTERS
DURATION_TIME_UNIT_ID
The unit of measure specified for the




duration


PLANNED_ENCOUNTERS
OFFSET
The magnitude of the quantity




measured in terms of the unit of the




offset from the target planned activity


PLANNED_ENCOUNTERS
OFFSET_TIME_UNIT_ID
The unit of measure specified for the




offset


PLANNED_ENCOUNTERS
OFFSET_BEFORE_AFTER_TYPE_ID
A relationship in which the target




planned activity takes place with a




defined temporal relationship with




respect to this planned activity. The




relationship could be offset from the




start or end of the target planned




activity


PLANNED_ENCOUNTERS
OFFSET_FROM_TYPE_ID
The type of planned activity to offset




from (e.g., treatment, procedure,




supply, etc.)


PLANNED_ENCOUNTERS
OFFSET_TREATMENT_ID
Offset from a target treatment


PLANNED_ENCOUNTERS
OFFSET_SUPPLY_ID
Offset from a target supply


PLANNED_ENCOUNTERS
OFFSET_PROCEDURE_ID
Offset from a target procedure


PLANNED_ENCOUNTERS
OFFSET_OBSERVATION_ID
Offset from a target observation


PLANNED_ENCOUNTERS
OFFSET_ADMINISTRATION_ID
Offset from a target substance




administration


PLANNED_ENCOUNTERS
OFFSET_ENCOUNTER_ID
Offset from a target encounter


PLANNED_ENCOUNTERS
SOURCE_ID
The id provided by the source




document


PLANNED_ENCOUNTERS
TREATMENT_ID
The treatment that this encounter is




within
















TABLE 53







Planned Observation Cross Table Types









Table Name
Entity/Column Name
Description





PLANNED_OBS_OBS_TYPES
ENTITY
The type of observation in coded




values. Since coded systems can be




post-coordinate, many codes could be




present


PLANNED_OBS_OBS_TYPES
SEQ
The order the code appeared in the




observation
















TABLE 54







Planned Observation









Table Name
Entity/Column Name
Description





PLANNED_OBSERVATIONS
ENTITY
A planned activity that is intended to




result in new information about a




subject. A description of what was




actually observed (“results” or




“answers”). It may be a


PLANNED_OBSERVATIONS
PLANNED_OBSERVATION_ID
Unique identifier


PLANNED_OBSERVATIONS
OBSERVATION_TYPE_ID
The type of observation (e.g., lab test)


PLANNED_OBSERVATIONS
METHOD_TYPE_ID
The means or technique used to




ascertain the observation. In all




observations the method is already




partially specified by the observation




type. In this case, the methodCode need




not be used at all. Examples: Blood




pressure measurement method: arterial




puncture vs. sphygmomanometer




(Riva-Rocci), sitting vs. supine position


PLANNED_OBSERVATIONS
INTERPRETATION_TYPE_ID
A qualitative interpretation of the




observation. These interpretation codes




are sometimes called “abnormal flags,”




however, the judgment of normalcy is




just one of the interpretations, and is




often not relevant.


PLANNED_OBSERVATIONS
PLANNED_ENCOUNTER_ID
Planned encounter where the




observation is within


PLANNED_OBSERVATIONS
TARGET_SITE_ID
The anatomical site or system that is




the focus of the observation. Most




observation target sites are implied by




the observation type. For example,




“heart murmur” always has the heart as




target. If the subject of the Observation




is something other than a human patient




or animal, the attribute is used




analogously to specify a structural




landmark of the thing where the




observation focuses.


PLANNED_OBSERVATIONS
DATATYPE_ID
Based on the data type certain fields




will be populated. The data type




examples include, coded, physical




quantity, string, real


PLANNED_OBSERVATIONS
NEGATION
Specifies this observation should not




occur


PLANNED_OBSERVATIONS
DESCRIPTION
Textual description of the observation


PLANNED_OBSERVATIONS
DURATION
The magnitude of the quantity




measured in terms of the unit of the




duration


PLANNED_OBSERVATIONS
DURATION_TIME_UNIT_ID
The unit of measure specified for the




duration


PLANNED_OBSERVATIONS
OFFSET
The magnitude of the quantity




measured in terms of the unit of the




offset from the target planned activity


PLANNED_OBSERVATIONS
OFFSET_TIME_UNIT_ID 
The unit of measure specified for the




offset


PLANNED_OBSERVATIONS
OFFSET_BEFORE_AFTER_TYPE_ID
A relationship in which the target




planned activity takes place with a




defined temporal relationship with




respect to this planned activity. The




relationship could be offset from the




start or end of the target planned




activity


PLANNED_OBSERVATIONS
OFFSET_FROM_TYPE_ID
The type of planned activity to offset




from (e.g., treatment, procedure,




supply, etc.)


PLANNED_OBSERVATIONS
OFFSET_SUPPLY_ID
Offset from a target supply


PLANNED_OBSERVATIONS
OFFSET_TREATMENT_ID
Offset from a target treatment


PLANNED_OBSERVATIONS
OFFSET_PROCEDURE_ID
Offset from a target procedure


PLANNED_OBSERVATIONS
OFFSET_OBSERVATION_ID
Offset from a target observation


PLANNED_OBSERVATIONS
OFFSET_ADMINISTRATION_ID
Offset from a target substance




administration


PLANNED_OBSERVATIONS
OFFSET_ENCOUNTER_ID
Offset from a target encounter


PLANNED_OBSERVATIONS
SOURCE_ID
The id provided by the source




document


PLANNED_OBSERVATIONS
TREATMENT_ID
The treatment that this encounter is




within
















TABLE 55







Planned Procedure









Table Name
Entity/Column Name
Description





PLANNED_PROCEDURES
ENTITY
A planned activity whose immediate




and primary outcome (post-condition)




is the alteration of the physical




condition of the subject. A procedure




does not comprise all planned activities




of whose intent is intervention.




Whether the bodily alteration is




appreciated or intended as beneficial to




the subject is likewise irrelevant.




Taking an x-ray image may sometimes




be called “procedure,” but it is not a




procedure, for an x-ray image is not




done to alter the physical condition of




the body. The X-Ray is a substance




administration


PLANNED_PROCEDURES
PLANNED_PROCEDURE_ID
Unique identifier


PLANNED_PROCEDURES
PROCEDURE_TYPE_ID
The type of procedure


PLANNED_PROCEDURES
PRODUCT_ID
The product applied in the procedure


PLANNED_PROCEDURES
METHOD_TYPE_ID
The means or technique used to




perform the procedure. For any




Procedure there may be several




different methods to achieve by and




large the same result, but may be




important to know when interpreting a




report more thoroughly (e.g.,




cholecystectomy: open vs.




laparoscopic).


PLANNED_PROCEDURES
PLANNED_ENCOUNTER_ID 
Planned encounter where the




observation is within


PLANNED_PROCEDURES
APPROACH_SITE_ID
The anatomical site or system through




which the procedure reaches its target.




For example: An arteria pulmonalis




catheter targets a pulmonary artery, but




the approach site is typically the vena




carotis interna at the neck or the vena




subclavia at the fossa subclavia.


PLANNED_PROCEDURES
TARGET_SITE_ID
The anatomical site or system that is




the focus of the procedure. For




example: An arteria pulmonalis catheter




targets a pulmonary artery, but the




approach site is typically the vena




carotis interna at the neck or the vena




subclavia at the fossa subclavia.


PLANNED_PROCEDURES
NEGATION
Specifies this procedure should not




occur


PLANNED_PROCEDURES
DESCRIPTION
Textual description of the procedure


PLANNED_PROCEDURES
DURATION
The magnitude of the quantity




measured in terms of the unit of the




duration


PLANNED_PROCEDURES
DURATION_TIME_UNIT_ID
The unit of measure specified for the




duration


PLANNED_PROCEDURES
OFFSET
The magnitude of the quantity




measured in terms of the unit of the




offset from the target planned activity


PLANNED_PROCEDURES
OFFSET_TIME_UNIT_ID 
The unit of measure specified for the




offset


PLANNED_PROCEDURES
OFFSET_BEFORE_AFTER_TYPE_ID
A relationship in which the target




planned activity takes place with a




defined temporal relationship with




respect to this planned activity. The




relationship could be offset from the




start or end of the target planned




activity


PLANNED_PROCEDURES
OFFSET_FROM_TYPE_ID
The type of planned activity to offset




from (e.g., treatment, procedure,




supply, etc.)


PLANNED_PROCEDURES
OFFSET_SUPPLY_ID
Offset from a target supply


PLANNED_PROCEDURES
OFFSET_TREATMENT_ID
Offset from a target treatment


PLANNED_PROCEDURES
OFFSET_PROCEDURE_ID
Offset from a target procedure


PLANNED_PROCEDURES
OFFSET_OBSERVATION_ID
Offset from a target observation


PLANNED_PROCEDURES
OFFSET_ADMINISTRATION_ID
Offset from a target substance




administration


PLANNED_PROCEDURES
OFFSET_ENCOUNTER_ID
Offset from a target encounter


PLANNED_PROCEDURES
SOURCE_ID
The id provided by the source




document


PLANNED_PROCEDURES
TREATMENT_ID
The treatment that this encounter is




within
















TABLE 56







Planned Research Subject









Table Name
Entity/Column Name 
Description





PLANNED_RESEARCH_SUBJECTS
ENTITY
The experimental unit is the physical




entity which is the primary unit of




interest in a study. In an interventional




study, the experimental unit is assigned




to an intervention. The experimental




unit is also the unit of primary




statistical analysis. Commonly the




individual subject (animal, person or




product) is the experimental unit.




Different experimental units must be




capable of receiving different




experimental interventions.




Accordingly if all pigs in a pen receive




the same intervention in their feed, and




the primary observations and analyses




of interest are associated with the entire




pen (e.g., total feed consumed, total




weight of all pigs combined), then the




pen of pigs rather than the individual




animal is the experimental unit. This




means that the statistical analysis may




be incorrect if it is assumed that the pig




is the experimental unit. In this case the




statistical analysis should normally be




done using the mean of all the pigs in




the pen. An example of when the




experimental unit is a product would be




product stress test or product




performance studies.


PLANNED_RESEARCH_SUBJECTS
PLANNED_RESEARCH_SUBJECT_ID
Unique identifier


PLANNED_RESEARCH_SUBJECTS 
STUDY_SITE_ID
Site where the planned subject will be




located


PLANNED_RESEARCH_SUBJECTS 
SPECIES_ID
The type of species


PLANNED_RESEARCH_SUBJECTS
PRODUCT_ID
The product that is the subject


PLANNED_RESEARCH_SUBJECTS 
RESEARCH_SUBJECT_TYPE_ID
The type of research subject (e.g.,




person, animal, virus, specimen, group,




part of organism, etc.)


PLANNED_RESEARCH_SUBJECTS
QUANTITY
The total amount of research subject




that will be of this type


PLANNED_RESEARCH_SUBJECTS
SOURCE_ID
The unique identifier in the source




document
















TABLE 57







Planned Specimen









Table Name
Entity/Column Name
Description





PLANNED_SPECIMENS
ENTITY
The type of specimen that 




is planned to be collected
















TABLE 58







Planned Subject Condition









Table Name
Entity/Column Name
Description





PLANNED_SUBJECT_CONDITIONS
ENTITY
Experimental units are sometimes




segregated based on certain criteria. For




example, site 1 might enroll 8 males




and 12 females, where site 2 enrolls 12




males and 8 females.


PLANNED_SUBJECT_CONDITIONS
PLANNED_SUBJECT_CONDITION_ID
Unique identifier


PLANNED_SUBJECT_CONDITIONS
PLANNED_RESEARCH_SUBJECT_ID
The planned research subject


PLANNED_SUBJECT_CONDITIONS
OBSERVATION_TYPE_ID
The condition


PLANNED_SUBJECT_CONDITIONS
DATATYPE_ID
Based on the data type certain fields




will be populated. The data type




examples include, coded, physical




quantity, string, real


PLANNED_SUBJECT_CONDITIONS
CONDITION_REAL
Used when the data type is physical




quantity, ratio or real. Result in a




numeric value of the observation


PLANNED_SUBJECT_CONDITIONS
CONDITION_UNIT_ID
Used when the data type is physical




quantity or ratio. The unit of measure




of the result. The numeric value will be




located in the result_real.


PLANNED_SUBJECT_CONDITIONS
CONDITION_STRING
Used when the data type is string. The




result of the observation


PLANNED_SUBJECT_CONDITIONS
CONDITION_DATE_LOW
Used when the data type is date. The




result of the observation


PLANNED_SUBJECT_CONDITIONS
CONDITION_DATE_HIGH
Used when the data type is date. The




result of the observation


PLANNED_SUBJECT_CONDITIONS
CONDITION_DENOM_REAL
Used when the data type is ratio. The




numeric denominator result of the




operation


PLANNED_SUBJECT_CONDITIONS
CONDITION_DENOM_UNIT_ID
Used when the data type is ration. The




unit of measure of the denominator of




the result of the observation


PLANNED_SUBJECT_CONDITIONS
NEGATION
Explains the results are the opposite of




what is stated


PLANNED_SUBJECT_CONDITIONS
DESCRIPTION
Textual description of the observation
















TABLE 59







Planned Subject









Table Name
Entity/Column Name 
Description





PLANNED_SUBJECTS_SUBJECTS
ENTITY
The relationship between subjects. e.g.,




members in a group or people of the




specimen
















TABLE 60







Planned Supplies









Table Name
Entity/Column Name
Description





PLANNED_SUPPLIES
ENTITY
Planned provision of a material by an




investigator to the experimental unit.




The precise identification of the




product (route, dosage form, serial




numbers, etc.) is important. Most of the




detailed infoimation about the Supply




should be represented using by the




product.


PLANNED_SUPPLIES
PLANNED_SUPPLY_ID
Unique id


PLANNED_SUPPLIES
SUPPLY_TYPE_ID
The type of supply


PLANNED_SUPPLIES
PRODUCT_ID
The product that is being supplied


PLANNED_SUPPLIES
PLANNED_ENCOUNTER_ID
The encounter where the supply occurs


PLANNED_SUPPLIES
DESCRIPTION
Textual description of the supply


PLANNED_SUPPLIES
QUANTITY
The amount of product that is to be




supplied.


PLANNED_SUPPLIES
QUANITITY_UNIT_ID
The unit of measure specified for the




quantity


PLANNED_SUPPLIES
EXPECTED_USE_HIGH
The period time over which the




supplied product is expected to be used.


PLANNED_SUPPLIES
EXPECTED_USE_LOW
The period time over which the




supplied product is expected to be used.


PLANNED_SUPPLIES
EXPECTED_USE_UNIT_ID
The unit of measure specified for the




expected use


PLANNED_SUPPLIES
OFFSET
The magnitude of the quantity




measured in terms of the unit of the




offset from the target planned activity


PLANNED_SUPPLIES
OFFSET_TIME_UNIT_ID
The unit of measure specified for the




offset


PLANNED_SUPPLIES
OFFSET_BEFORE_AFTER_TYPE_ID
A relationship in which the target




planned activity takes place with a




defined temporal relationship with




respect to this planned activity. The




relationship could be offset from the




start or end of the target planned




activity


PLANNED_SUPPLIES
OFFSET_FROM_TYPE_ID
The type of activity to offset from (e.g.,




treatment, procedure, supply, etc.)


PLANNED_SUPPLIES
OFFSET_TREATMENT_ID
Offset from a target treatment


PLANNED_SUPPLIES
OFFSET_SUPPLY_ID
Offset from a target supply


PLANNED_SUPPLIES
OFFSET_PROCEDURE_ID
Offset from a target procedure


PLANNED_SUPPLIES 
OFFSET_OBSERVATION_ID 
Offset from a target observation


PLANNED_SUPPLIES 
OFFSET_ADMINISTRATION_ID 
Offset from a target substance




administration


PLANNED_SUPPLIES
OFFSET_ENCOUNTER_ID
Offset from a target encounter


PLANNED_SUPPLIES 
SOURCE_ID
The id provided by the source




document


PLANNED_SUPPLIES
TREATMENT_ID
The treatment that this encounter is




within
















TABLE 61







Planned Subject Condition Observation Type









Table Name
Entity/Column Name 
Description





PLND_SUBJCT_COND_OBS_TYPES
ENTITY
The type of observation in coded




values. Since coded systems can be




post-coordinate, many codes could be




present


PLND_SUBJCT_COND_OBS_TYPES
SEQ
The order the code appeared in the




observation
















TABLE 62







Planned Subject Condition Result Type










Entity/




Column 



Table Name
Name
Description





PLND_SUBJCT_COND_RESULT_TYPES
ENTITY
Results of the 




observation for 




coded values. Since




coded systems can 




be post-coordinate,




many codes could 




be present
















TABLE 63







Procedure Type









Table Name
Entity/Column Name
Description





PROCEDURE_TYPES
ENTITY
The type of 




procedure


PROCEDURE_TYPES
PROCEDURE_TYPE_ID
Unique identifier


PROCEDURE_TYPES
DESCRIPTION
Friendly name of 




identifier


PROCEDURE_TYPES
CODE
Code from the 




coding system


PROCEDURE_TYPES
CODE_SYSTEM
Code system of the 




code


PROCEDURE_TYPES
CODE_SYSTEM_VERSION
Version of the code 




system version




of the code
















TABLE 64







Procedures









Table Name
Entity/Column Name
Description





PROCEDURES
ENTITY
An actual activity whose




immediate and primary 




outcome (post-




condition) is the 




alteration of the 




physical condition of the 




subject. A procedure 




does not comprise 




all actual activities 




of whose intent 




is intervention.




Whether the bodily 




alteration is 




appreciated or intended 




as beneficial to the 




subject is likewise 




irrelevant. Taking




an x-ray image may




sometimes be called 




“procedure,” but it is 




not a procedure, for an 




x-ray image is not 




done to alter the 




physical condition of 




the body. The X-Ray 




is a substance 




administration


PROCEDURES
PROCEDURE_ID
Unique identifier


PROCEDURES
PROCEDURE_TYPE_ID
The type of procedure


PROCEDURES
PRODUCT_ID
The product applied in 




the procedure


PROCEDURES
METHOD_TYPE_ID
The means or technique 




used to perform the




procedure. For any 




Procedure there may 




be several different 




methods to achieve by 




and large the same 




result, but may be 




important to know 




when interpreting a 




report more thoroughly 




(e.g., cholecystectomy: 




open vs. laparoscopic).


PROCEDURES
ENCOUNTER_ID
The encounter where the 




procedure occurred


PROCEDURES
APPROACH_SITE_ID
The anatomical site or 




system through which 




the procedure reaches




its target. For example: 




An arteria pulmonalis 




catheter targets a 




pulmonary artery, but 




the approach site is 




typically the vena 




carotis interna at the




neck or the vena




subclavia at the 




fossa subclavia.


PROCEDURES
TARGET_SITE_ID
The anatomical site or




system that is the focus




of the procedure. For 




example: An arteria




pulmonalis catheter 




targets a pulmonary 




artery, but the approach 




site is typically the vena 




carotis interna at the 




neck or the vena 




subclavia at the fossa 




subclavia.


PROCEDURES
NEGATION
That the procedure did 




not occur


PROCEDURES
DESCRIPTION
Textual description of




the procedure


PROCEDURES
DATE_EFFECTIVE_HIGH
The date the procedure 




occurred


PROCEDURES
DATE_EFFECTIVE_LOW
The date the procedure 




occurred


PROCEDURES
AVAILABLE_DATE
The point in time at 




which information 




about this procedure 




first became available 




to a system reproducing 




this administration. 




The availability date 




is metadata describing




the record, not the 




procedure.


PROCEDURES
DURATION
The magnitude of the 




quantity measured in 




terms of the unit of 




the duration


PROCEDURES
DURATION_TIME_UNIT_ID
The unit of measure 




specified for the 




duration


PROCEDURES
SOURCE_ID
The id provided by the 




source document


PROCEDURES
RESEARCH_SUBJECT_ID
The subject of the 




procedure


PROCEDURES
DATE_ENTERER
The person who entered




the data


PROCEDURES
MODIFIED_REASON
The reason for the 




modification


PROCEDURES
MODIFIED_PROCEDURE_ID
The procedure records 




that this records 




modifies


PROCEDURES
DEVICE_ID
The device that recorded 




the procedure


PROCEDURES
INVESTIGATOR_ID
The investigator that




recorded the procedure


PROCEDURES
SERVICE_PROVIDER_ID
The service provided 




that recorded the




procedure


PROCEDURES
PLANNED_PROCEDURE_ID
The planned procedure 




as specified in the




protocol


PROCEDURES
TREATMENT_ID
The treatment that this 




procedure is within


PROCEDURES
IS_CURRENT
If true the this record is 




the most current
















TABLE 65







Product Instance









Table Name
Entity/Column Name
Description





PRODUCT_INSTANCE
ENTITY
Information for a 




particular product 




instance, or amount 




of the product.


PRODUCT_INSTANCE
PRODUCT_INSTANCE_ID
Unique identifier


PRODUCT_INSTANCE
PRODUCT_ID
The product


PRODUCT_INSTANCE
LOT_ID
The lot
















TABLE 66







Product Part









Table Name
Entity/Column Name
Description





PRODUCT_PARTS
ENTITY
Products could be 




combination products 




or the parts could 




be of interest


PRODUCT_PARTS
PRODUCT_ID
Product identifier


PRODUCT_PARTS
PARENT_PRODUCT_ID
The product of whom 




this product is




a part of


PRODUCT_PARTS
QUANTITY
The number of this 




product in the 




parent product


PRODUCT_PARTS
UNIT_ID
Unit of measure of the




quantity of products
















TABLE 67







Product Types









Table Name
Entity/Column Name
Description





PRODUCT_TYPES
ENTITY
The type of product


PRODUCT_TYPES
PRODUCT_TYPE_ID
Unique identifier


PRODUCT_TYPES
DESCRIPTION
Friendly name of 




identifier


PRODUCT_TYPES
CODE
Code from the 




coding system


PRODUCT_TYPES
CODE_SYSTEM
Code system of the




code


PRODUCT_TYPES
CODE_SYSTEM_VERSION
Version of the code 




system version of 




the code
















TABLE 68







Product









Table Name
Entity/Column Name
Description





PRODUCTS
ENTITY
A product, like a device or pill, 




could be the experimental unit 




of the study or the product used 




to extract the specimen.


PRODUCTS
PRODUCT_ID
Unique identifier


PRODUCTS
PRODUCT_TYPE_ID
The kind of product


PRODUCTS
PROPRIETARY_NAME
The name of the product as per 




the manufacturer


PRODUCTS
DOSAGE_FORM_ID
The dosage form (e.g., tablet) 




of the product


PRODUCTS
MODEL_NUMBER
The product identifier as per 




the manufacturer


PRODUCTS
SOFTWARE_NAME
The software name and 




version of the product
















TABLE 69







Qualification Type









Table Name
Entity/Column Name
Description





QUALIFICATION_TYPES
ENTITY
The type of 




qualifications 




(e.g., MD, 




board




certifications, 




etc.)


QUALIFICATION_TYPES
QUALIFICATION_TYPE_ID 
Unique 




identifier


QUALIFICATION_TYPES
DESCRIPTION
Friendly name 




of identifier


QUALIFICATION_TYPES
CODE
Code from the 




coding system


QUALIFICATION_TYPES
CODE_SYSTEM
Code system 




of the code


QUALIFICATION_TYPES
CODE_SYSTEM_VERSION
Version of the 




code system 




version of the




code
















TABLE 70







Qualification









Table Name
Entity/Column Name
Description





QUALIFICATIONS
ENTITY
A skill, achievement, 




etc, that demonstrates 




that a person capable




or suitable to do a




job etc.


QUALIFICATIONS
QUALIFICATION_ID
Unique identifier


QUALIFICATIONS
INVESTIGATOR_ID
Investigator


QUALIFICATIONS
QUALIFICATION_TYPE_ID
The type of 




qualifications (e.g., 




MD, board 




certifications, etc.)


QUALIFICATIONS
DATE_HIGH
The end date of the 




qualification


QUALIFICATIONS
DATE_LOW
The start date of the 




qualification


QUALIFICATIONS
ISSUER_NAME
The name of the 




issuing party of the




qualification


QUALIFICATIONS
ISSUER_ADDRESS1
The address of the 




issuing party of the




qualification


QUALIFICATIONS
ISSUER_ADDRESS2
The address of the 




issuing party of




the qualification


QUALIFICATIONS
ISSUER_CITY
The city of the 




issuing party of 




the qualification


QUALIFICATIONS
ISSUER_STATE
The state of the 




issuing party of the




qualification


QUALIFICATIONS
ISSUER_COUNTRY
The country of the 




issuing party of the




qualification
















TABLE 71







Quantity Units









Table Name
Entity/Column Name
Description





QUANTITY_UNITS
ENTITY
A dimensioned 




quantity expressing




the result of 




measuring


QUANTITY_UNITS
QUANTITY_UNIT_ID
Unique identifier


QUANTITY_UNITS
DESCRIPTION
Friendly name of




identifier


QUANTITY_UNITS
CODE
Code from the coding




system


QUANTITY_UNITS
CODE_SYSTEM
Code system of the 




code


QUANTITY_UNITS
CODE_SYSTEM_VERSION
Version of the code 




system version of 




the code
















TABLE 72







Race











Table Name
Entity/Column Name
Description







RACES
ENTITY
The race

















TABLE 73







Reference Criteria Observation Types










Entity/




Column 



Table Name
Name
Description





REF_CRITERIA_OBS_TYPES
ENTITY
The type of observation 




in coded values. Since 




coded systems can be 




post-coordinate, many




codes could be present


REF_CRITERIA_OBS_TYPES
SEQ
The order the code 




appeared in the




observation
















TABLE 74







Reference Observation High Type










Entity/




Column 



Table Name
Name
Description





REFERENCE_OBS_RES_HIGH_TYPES
ENTITY
The type of 




observation in 




coded values. 




Since coded 




systems can be




post-coordinate, 




many codes




could be present


REFERENCE_OBSERVATION_TYPES
SEQ
The order the 




code appeared in 




the observation
















TABLE 75







Reference Observation Low Type










Entity/




Column



Table Name
Name
Description





REFERENCE_OBS_RES_LOW_TYPES
ENTITY
The type of 




observation in 




coded values.




Since coded 




systems can be 




post-coordinate,




many codes 




could be present


REFERENCE_OBSERVATION_TYPES
SEQ
The order the code 




appeared in the




observation
















TABLE 76







Reference Observation Types










Entity/ 




Column



Table Name
Name
Description





REFERENCE_OBSERVATION_TYPES
ENTITY
The type of 




observation in 




coded values. 




Since coded 




systems can be




post-coordinate, 




many codes could 




be present


REFERENCE_OBSERVATION_TYPES
SEQ
The order the code 




appeared in the




observation
















TABLE 77







Reference Range Criteria









Table Name
Entity/Column Name
Description





REFERENCE_RANGE_
ENTITY
The criteria uses to determine is the


CRITERIA

reference range is appropriate


REFERENCE_RANGE_
OBSERVATION 
Unique identifier


CRITERIA
CRITERION_ID



REFERENCE_RANGE_
REFERENCE_CRITE-
Should this be observation type


CRITERIA
RION_TYPE_ID



REFERENCE_RANGE_
REFERENCE_ 
The reference range


CRITERIA
RANGE_ID



REFERENCE_RANGE_
PARENT_ID
When the criteria is complex, the parent


CRITERIA

criteria


REFERENCE_RANGE_
CONJUNCTION_
The logical conjunction of the criteria


CRITERIA
TYPE_ID
among all the rules (e.g., and, or,




exclusive-or).


REFERENCE_RANGE_
DATATYPE_ID
Based on the data type certain fields


CRITERIA

will be populated. The data type




examples include, coded, physical




quantity, string, real


REFERENCE_RANGE_
RESULT_REAL
Used when the data type is physical


CRITERIA

quantity, ratio or real. Result in a




numeric value of the observation


REFERENCE_RANGE_
RESULT_UNIT_ID
Used when the data type is physical


CRITERIA

quantity or ratio. The unit of measure




of the result. The numeric value will be




located in the result_real. The low end




of the range.


REFERENCE_RANGE_
RESULT_STRING
Used when the data type is string. The


CRITERIA

result of the observation


REFERENCE_RANGE_
RESULT_
Used when the data type is date. The


CRITERIA
DATE_LOW
result of the observation


REFERENCE_RANGE_
RESULT_
Used when the data type is date. The


CRITERIA
DATE_HIGH
result of the observation


REFERENCE_RANGE_
RESULT_DENOM_ 
Used when the data type is ratio. The


CRITERIA
REAL
numeric denominator result of the




operation


REFERENCE_RANGE_
RESULT_DENOM_
Used when the data type is ration. The


CRITERIA
UNIT_ID
unit of measure of the denominator of




the result of the observation


REFERENCE_RANGE_
NEGATION
Explains the results are the opposite of


CRITERIA

what is stated


REFERENCE_RANGE_
SEQ
The order of this criteria within the


CRITERIA

parent
















TABLE 78







Reference Range Types









Table Name
Entity/Column Name
Description





REFERENCE_
ENTITY
Could be possible values (e.g., a


RANGE_TYPES

thermometer can produce values 




from 92-108), linear range 




(e.g., a thermometer is accurate 




from 97-105), normal range 




(e.g., a healthy patient would 




be in the range of 98-99)


REFERENCE_
REFERENCE_
Unique identifier


RANGE_TYPES
RANGE_TYPE_ID



REFERENCE_
DESCRIPTION
Friendly name of identifier


RANGE_TYPES




REFERENCE_
CODE
Code from the coding system


RANGE_TYPES




REFERENCE_
CODE_SYSTEM
Code system of the code


RANGE_TYPES




REFERENCE_
CODE_SYSTEM_ 
Version of the code system 


RANGE_TYPES
VERSION
version of the code
















TABLE 79







Reference Range









Table Name
Entity/Column Name
Description





REFERENCE_
ENTITY
Reference ranges are essentially


RANGES

descriptors of a result values 




assumed to be “normal”, 




“abnormal”, or “critical.” Those 




can vary by sex, age, or any 




other criterion.


REFERENCE_
REFERENCE_
Unique Identifier


RANGES
RANGE_ID



REFERENCE_
OBSERVATION_ID
The observation where the range


RANGES

applies to


REFERENCE_
INTERPRE-
A qualitative interpretation of the


RANGES
TATION_TYPE_ID
observation. These interpretation 




codes are sometimes called 




“abnormal flags,” however, the 




judgment of normalcy is just 




one of the interpretations, 




and is often not relevant.


REFERENCE_
RESULT_
Used when the data type is physical


RANGES
LOW_REAL
quantity, ratio or real. Result in a




numeric value of the observation. 




The low end of the range.


REFERENCE_
RESULT_LOW_
Used when the data type is physical


RANGES
UNIT_ID
quantity or ratio. The unit of measure




of the result. The numeric value 




will be located in the result_real. 




The low end of the range.


REFERENCE_
RESULT_
Used when the data type is string. 


RANGES
LOW_STRING
The result of the observation. 




The low end of the range


REFERENCE_
RESULT_LOW_
Used when the data type is date. The


RANGES
DATE_LOW
result of the observation. The low 




end of the range.


REFERENCE_
RESULT_LOW_
Used when the data type is date. The


RANGES
DATE_HIGH
result of the observation. The low 




end of the range.


REFERENCE_
RESULT_LOW_
Used when the data type is ratio. The


RANGES
DENOM_REAL
numeric denominator result of the




operation. The low end of the range


REFERENCE_
RESULT_LOW_
Used when the data type is ration. 


RANGES
DENOM_UNIT_ID
The unit of measure of the 




denominator of the result of the 




observation. The low end of the 




range.


REFERENCE_
RESULT_HIGH_
Used when the data type is physical


RANGES
REAL
quantity, ratio or real. Result in a




numeric value of the observation. 




The high end of the range.


REFERENCE_
RESULT_HIGH_ 
Used when the data type is physical


RANGES
UNIT_ID
quantity or ratio. The unit of measure




of the result. The numeric value 




will be located in the result_real. 




The low end of the range.


REFERENCE_
RESULT_HIGH_
Used when the data type is string. 


RANGES
STRING
The result of the observation. 




The high end of the range


REFERENCE_
RESULT_HIGH_
Used when the data type is date. 


RANGES
DATE_LOW
The result of the observation. 




The low high of the range.


REFERENCE_
RESULT_HIGH_
Used when the data type is date. The


RANGES
DATE_HIGH
result of the observation. The




low high of the range.


REFERENCE_
RESULT_HIGH_
Used when the data type is ratio. The


RANGES
DENOM_REAL
numeric denominator result of the




operation. The high end of the range


REFERENCE_
RESULT_HIGH_
Used when the data type is ration. 


RANGES
DENOM_UNIT_ID
The unit of measure of the 




denominator of the result of the 




observation. The high end of 




the range.


REFERENCE_
DESCRIPTION
The textual description of the range


RANGES




REFERENCE_
NEGATION
Specifies the opposite.


RANGES




REFERENCE_
RESULT_LOW_
The source text of the low end of the


RANGES
REAL_SOURCE
range


REFERENCE_
RESULT_HIGH_
The source text of the high end of the


RANGES
REAL_SOURCE
range
















TABLE 80







Reference Result Code Type









Table Name
Entity/Column Name
Description





REFERENCE_
ENTITY
Results of the observation for 


RESULT_

coded values. Since coded 


CODE_TYPES

systems can be post-coordinate, 




many codes could be present
















TABLE 81







Reports









Table Name
Entity/Column Name
Description





REPORTS
ENTITY
The safety report


REPORTS
REPORT_ID
Unique identifier


REPORTS
COMPLETED
When the report was complete


REPORTS
AVAILABLE
When the report was made available
















TABLE 82







Report Documents









Table Name
Entity/Column Name
Description





REPORTS_
ENTITY
There could be many documents


DOCUMENTS

associated to a report
















TABLE 83







Research Subject Identifiers









Table Name
Entity/Column Name
Description





RESEARCH_SUBJECT_
ENTITY
Other identifiers of 


IDENTIFIERS

the subject


RESEARCH_SUBJECT_
RESEARCH_
Subject


IDENTIFIERS
SUBJECT_ID



RESEARCH_SUBJECT_
IDENTIFIER
Other identifier


IDENTIFIERS




RESEARCH_SUBJECT_
IDENTIFIER_NAME
The organization 


IDENTIFIERS

providing the identifier
















TABLE 84







Research Subject Types









Table Name
Entity/Column Name
Description





RESEARCH_
ENTITY
The type of research sub-


SUBJECT_TYPES

ject (e.g., person, animal, 




specimen, group, etc.)


RESEARCH_
RESEARCH_
Unique identifier


SUBJECT_TYPES
SUBJECT




TYPE_ID



RESEARCH_
DESCRIPTION
Textual description or 


SUBJECT_TYPES

friendly name
















TABLE 85







Research Subjects









Table Name
Entity/Column Name
Description





RESEARCH_
ENTITY
The experimental unit is the physical


SUBJECTS

entity which is the primary unit of




interest in a study. In an interven-




tional study, the experimental 




unit is assigned to an intervention. 




The experimental unit is also the unit 




of primary statistical analysis. 




Commonly the individual subject 




(animal, person or product) is the 




experimental unit.




Different experimental units must 




be capable of receiving different




experimental interventions.




Accordingly if all pigs in a pen 




receive the same intervention in their




feed, and the primary observations 




and analyses of interest are 




associated with the entire pen 




(e.g., total feed consumed, 




total weight of all pigs combined), 




then the pen of pigs rather than 




the individual animal is the 




experimental unit. This means that 




the statistical analysis may be 




incorrect if it is assumed that the pig




is the experimental unit. In this 




case the statistical analysis should 




normally be done using the mean 




of all the pigs in the pen. An 




example of when the experimental 




unit is a product would be




product stress test or product




performance studies.
















TABLE 86







Result Types









Table Name
Entity/Column Name
Description





RESULT_TYPES
ENTITY
The type of results (e.g., 




need examples)


RESULT_TYPES
RESULT_TYPE_ID
Unique identifier


RESULT_TYPES
CODE
Code from the coding system


RESULT_TYPES
CODE_SYSTEM
Code system of the code


RESULT_TYPES
CODE_SYSTEM_ 
Version of the code system 



VERSION
version of the code


RESULT_TYPES
DESCRIPTION
Friendly name of identifier
















TABLE 87







Results









Table Name
Entity/Column Name
Description





RESULTS
ENTITY
Any outcome or actions taken (e.g.,




stop taking drug)


RESULTS
RESULT_ID
Unique Identifier


RESULTS
ASSESSMENT_ID
The assessment


RESULTS
RESULT_TYPE_ID
The type of result


RESULTS
DATA_TYPE_ID
Based on the data type certain fields




will be populated. The data type




examples include, coded. physical




quantity, string, real


RESULTS
RESULT_REAL
Used when the data type is physical




quantity, ratio or real. Result in a




numeric value of the observation


RESULTS
RESULT_UNIT_ID
Used when the data type is physical




quantity or ratio. The unit of measure




of the result. The numeric value will be




located in the result_real.


RESULTS
RESULT_STRING
Used when the data type is string. The




result of the observation


RESULTS
RESULT_ 
Used when the data type is date. The



DATE_LOW
result of the observation


RESULTS
RESULT_ 
Used when the data type is date. The



DATE_HIGH
result of the observation


RESULTS
RESULT_DENOM_ 
Used when the data type is ratio. The



REAL
numeric denominator result of the




operation


RESULTS
RESULT_DENOM_
Used when the data type is ration. The



UNIT_ID
unit of measure of the denominator of




the result of the observation


RESULTS
RESULT_SOURCE
Original text of the result


RESULTS
RESULT_SOURCE_ 
Original text of the result unit



UNIT
















TABLE 88







Routes of Administration









Table Name
Entity/Column Name
Description





ROUTES
ENTITY
The physiological path or route for




introducing the therapeutic material




into or onto the subject.


ROUTES
ROUTE_ID
Unique identifier


ROUTES
DESCRIPTION_
Friendly name of identifier


ROUTES
CODE
Code from the coding system


ROUTES
CODE_SYSTEM
Code system of the code


ROUTES
CODE_SYSTEM_
Version of the code system 



VERSION
version of the code
















TABLE 89







Service Delivery Location









Table Name
Entity/Column Name
Description





SERVICE_DELIVERY
ENTITY
The physical location 


LOCATIONS

of activities


SERVICE_DELIVERY
LOCATION_
The type of the location 


LOCATIONS
TYPE_ID
(e.g., hospital, clinic)
















TABLE 90







Service Provider









Table Name
Entity/Column Name
Description





SERVICE_
ENTITY
There are many service providers that


PROVIDERS 

are involved in a study. It is important




to list some, not all, service providers




involved in a study. For example, this




information could be used to find all




contract research organizations




involved in all active studies.


SERVICE_
SERVICE_PROVI-
Unique identifier


PROVIDERS 
DER_ID



SERVICE_
NAME
Name of provider


PROVIDERS
















TABLE 91







Service Provider in Study









Table Name
Entity/Column Name
Description





SERVICE_PROVI-
ENTITY
One service provider 


DERS_STUDIES

and provide services 




for many studies


SERVICE_PROVI-
SERVICE_PROVI-
Service provider


DERS_STUDIES
DER_ID



SERVICE_PROVI-
SITE_ID
Site where the 


DERS_STUDIES

services take place


SERVICE_PROVI-
STUDY_
Study of the services


DERS_STUDIES
MASTER_ID
















TABLE 92







Sites









Table Name
Entity/Column Name
Description





SITES
ENTITY
Site of the study.
















TABLE 93







Species









Table Name
Entity/Column Name
Description





SPECIES
ENTITY
The type or kind of




animal/virus/organism


SPECIES
SPECIES_ID
Unique identifier


SPECIES
DESCRIPTION
Friendly name of identifier


SPECIES
CODE
Code from the coding system


SPECIES
CODE_SYSTEM
Code system of the code


SPECIES
CODE_SYSTEM_
Version of the code system 



VERSION
version of the code
















TABLE 94







Specimen Types









Table Name
Entity/Column Name
Description





SPECIMEN_TYPES
ENTITY
categorize the type of 




specimen


SPECIMEN_TYPES
SPECIMEN_TYPE_ID
Unique identifier


SPECIMEN_TYPES
DESCRIPTION
Friendly name of identifier


SPECIMEN_TYPES
CODE
Code from the coding system


SPECIMEN_TYPES
CODE_SYSTEM
Code system of the code


SPECIMEN_TYPES
CODE_SYSTEM_
Version of the code system 



VERSION
version of the code
















TABLE 95







Specimen









Table Name
Entity/Column Name
Description





SPECIMENS
ENTITY
A sample used for analysis 




or diagnosis


SPECIMENS
SPECIMEN_ID
Unique identifier


SPECIMENS
SPECIMEN_
categorize the type 



TYPE_ID
of specimen


SPECIMENS
PROCEDURE_ID
Procedure, if any, used 




to extract the specimen


SPECIMENS
COLLECTED_
Date when the specimen 



LOW
was collected


SPECIMENS
COLLECTED_
Date when the specimen 



HIGH
was collected


SPECIMENS
SOURCE_ID
Identifier of the specimen as 




per the source document
















TABLE 96







Status









Table Name
Entity/Column Name
Description





STATUSES
ENTITY
Different states. This is a look up table.
















TABLE 97







Study Site Location











Table Name
Entity/Column Name
Description







STUDIES_SITE_
ENTITY
The same location can 



LOCATIONS

be used for many sites

















TABLE 98







Study Sites









Table 
Entity/



Name
Column Name
Description





STUDIES_
ENTITY
The main location where 


SITES

study actual activities are 




conducted. One site can




be for many studies


STUDIES_
SITE ID
Unique identifier


SITES




STUDIES_
STUDY_
With site id, this is 


SITES
MASTER_ID
the unique identifier


STUDIES_
SOURCE_ID
The identifier of the study 


SITES

site in the source document
















TABLE 99







Study Sites Statues









Table Name
Entity/Column Name
Description





STUDIES_
ENTITY
The status of site. The status 


SITES_

could be null (not started), in 


STATUSES

progress, hold or complete
















TABLE 100







Study Characteristic Types










Entity/



Table Name
Column Name
Description





STUDY_CHARAC-
ENTITY
The type of study characteristics 


TERISTIC_TYPES

(e.g.; blinding schema, intent, phase,




randomization, objectives, blinding




Schema, confidentiality, monitor




disease, intent, phase randomized




Indicator, populated description,




intervention, duration, study 




duration)


STUDY_CHARAC-
STUDY_
Unique identifier


TERISTIC_TYPES
CHARAC-




TERISTIC_




TYPE_ID



STUDY_CHARAC-
CODE
Code from the coding system


TERISTIC_TYPES




STUDY_CHARAC-
CODE_
Code system of the code


TERISTIC_TYPES
SYSTEM



STUDY_CHARAC-
CODE_
Version of the code system version 


TERISTIC_TYPES
VERSION
of the code


STUDY_CHARAC-
DESCRIP-
Friendly name of identifier


TERISTIC_TYPES
TION
















TABLE 101







Study Definition









Table Name
Entity/Column Name
Description





STUDY_DEFINITIONS
ENTITY
An action plan for a formal




investigation to assess the utility,




impact, pharmacological, physiological,




and psychological effects of a particular




treatment, procedure, drug, device,




biologic, food product, cosmetic, care




plan, or subject characteristic.




Note: Among other things, the action




plan may include the design, statistical




considerations and all planned activities




to test a particular hypothesis that is the




basis of the study. Subjects may be




biological entities (human, animal,




specimen, tissue, organ, etc.) or




products.




The study may be of any type that




involves subjects, including prevention,




therapeutic, interventional or




observational.


STUDY_DEFINITIONS 
STUDY_ 
Unique Identifier



DEFINITION_ID



STUDY_DEFINITIONS 
TITLE
A brief description of the study.


STUDY_DEFINITIONS
SOURCE_ID
Identifier in the source document


STUDY_DEFINITIONS 
DESCRIPTION
Full description of the study


STUDY_DEFINITIONS 
VERSION
Protocol version number


STUDY_DEFINITIONS 
MODIFIED_REASON
Reason for modification


STUDY_DEFINITIONS 
IS_CURRENT
Is this study definition the most 




current study definition
















TABLE 102







Study Definition Sites









Table Name
Entity/Column Name
Description





STUDY_DEFINI-
ENTITY
A study site uses a version of 


TIONS_SITES

a protocol at a certain time


STUDY_DEFINI-
START
start date of protocol 


TIONS_SITES

version


STUDY_DEFINI-
END
End date of the protocol 


TIONS_SITES

version
















TABLE 103







Study Events









Table Name
Entity/Column Name
Description





STUDY_EVENTS
ENTITY
The study that is executed. 




The same study can be 




executed many times


STUDY_EVENTS
DATE_LOW
The start of the study


STUDY_EVENTS
DATE_HIGH
The end of the study
















TABLE 104







Study Event Statuses









Table Name
Entity/Column Name
Description





STUDY_
ENTITY
The status of study. The status 


EVENTS_

could be null (not started), in 


STATUSES

progress, hold or complete
















TABLE 105







Study Identifiers









Table Name
Entity/Column Name
Description





STUDY_IDENTIFIERS
ENTITY
A study can have many identifiers


STUDY_IDENTIFIERS
STUDY_MASTER_ID
Unique identifier


STUDY_IDENTIFIERS
IDENTIFIER
The alternative identifier


STUDY_IDENTIFIERS
IDENTIFIER_NAME
Organization provided the alternative




identifier or identifier name
















TABLE 106







Study Master









Table Name
Entity/Column Name
Description





STUDY_
ENTITY
A study can have many different


MASTERS

protocols (study definition) and be




executed many different times (study




event)
















TABLE 107







Study Status Types










Entity/Column



Table Name
Name
Description





STUDY_STATUS_TYPES
ENTITY
The status of the study, 




such as “recruiting 




subjects” and “active”
















TABLE 108







Subject Protection Approval









Table Name
Entity/Column Name
Description





SUBJECT_PROTECTION_APPROVALS
ENTITY
The purpose of a subject protection




approval (by an Institutional review




board (IRB), independent ethics




committee (IEC) or ethical review




board (ERB)) is to assure, both in




advance and by periodic review, that




appropriate steps are taken to protect




the rights and welfare of humans




participating as subjects in a research




study. To accomplish this purpose,




ethical committees review research




protocols and related materials (e.g.,




informed consent documents and




investigator brochures) to ensure




protection of the rights and welfare of




human subjects of research. The chief




objectives of every ethical committee




protocol review are to assess the




scientific merit of the research and its




methods, to promote fully informed and




voluntary participation by prospective




subjects who are themselves capable of




making such choices (or, if that is not




possible, informed permission given by




a suitable proxy) and to maximize the




safety of subjects once they are enrolled




in the project.


SUBJECT_PROTECTION_APPROVALS
SUBJECT_PROTECTION_APPROVAL_ID
Unique identifier


SUBJECT_PROTECTION_APPROVALS
ETHICAL_COMMITTEE_ID
The ethical committee making the




approval judgment


SUBJECT_PROTECTION_APPROVALS
EFFECTIVE_DATE_LOW
The period of time during which the




approval is in effect.


SUBJECT_PROTECTION_APPROVALS
EFFECTIVE_DATE_HIGH
The period of time during which the




approval is in effect.


SUBJECT_PROTECTION_APPROVALS
AVAILABLE_DATE
When the approval was recorded by the




ethical committee. For example, if the




ethical committee made a decision on




June 4th that the study can be




conducted at a certain site for one year




started in July 1st. June 4th would be




the availability time and July 1st for




one year would be the effective time.


SUBJECT_PROTECTION_APPROVALS
SITE_ID
The study site that is the subject of the




approval


SUBJECT_PROTECTION_APPROVALS
STUDY_MASTER_ID
The study master of the site in question
















TABLE 109







Subject Relationship Types









Table Name
Entity/Column Name
Description





SUBJECT_RELATIONSHIP_TYPES
ENTITY
The type of relationship (e.g., part.




specimen, family member, etc.)


SUBJECT_RELATIONSHIP_TYPES
SUBJECT_RELATIONSHIP_TYPE_ID
Unique identifier


SUBJECT_RELATIONSHIP_TYPES
DESCRIPTION
Friendly name or description
















TABLE 110







Subject Cross Table









Table Name
Entity/Column Name
Description





SUBJECTS_SUBJECTS
ENTITY
The relationship between subjects. e.g.,




members in a group or people of the




specimen


SUBJECTS_SUBJECTS
SUBJECT_RELATIONSHIP_TYPE_ID
The type of relationship (e.g., part,




specimen, family member, etc.)
















TABLE 111







Substance Administration









Table Name
Entity/Column Name
Description





SUBSTANCE_ADMINISTRATIONS
ENTITY
A type of procedure that involves a




performer introducing or otherwise




applying a product into or to the




experimental unit. For purposes of this




definition, photons and other models of




radiation or light energy are considered




substances. Substances may also




include living entities such as live virus




vaccines and other materials containing




infectious agents, e.g., saliva, blood




products, etc.


SUBSTANCE_ADMINISTRATIONS
SUBSTANCE_ADMINISTRATION_ID
Unique identifier


SUBSTANCE_ADMINISTRATIONS
ADMINISTRATION_TYPE_ID
The type of administration


SUBSTANCE_ADMINISTRATIONS
PRODUCT_ID
The product that was administered


SUBSTANCE_ADMINISTRATIONS
ROUTE_ID
The physiological path or route for




introducing the therapeutic product into




or onto the subject.


SUBSTANCE_ADMINISTRATIONS
ENCOUNTER_ID
The encounter where the administration




occurred


SUBSTANCE_ADMINISTRATIONS
APPROACH_SITE_ID
The anatomical site or system through




which the administration reaches its




target. If the route is intravenous or




intra-muscular, it may be necessary to




specify the precise site, with approach




site, (e.g., right forearm or left deltoid




muscle respectively)


SUBSTANCE_ADMINISTRATIONS
DOSE_UNIT_ID
The unit of measure specified for the




dose. The dose may be specified either




as a physical quantity of active




ingredient (e.g., 200 mg) or as the




count of administration-units (e.g.,




tablets, capsules, etc).


SUBSTANCE_ADMINISTRATIONS
DOSE
The amount of the administered




substance or other substance given at




one administration event


SUBSTANCE_ADMINISTRATIONS
DOSE_TEXT
The description of the dose as provided




by the source


SUBSTANCE_ADMINISTRATIONS
DOSE_MODIFICATION_REASON
The reason why the dose was modified




from the protocol


SUBSTANCE_ADMINISTRATIONS
NEGATION
That the administration did not occur


SUBSTANCE_ADMINISTRATIONS
DESCRIPTION
Description of the administration


SUBSTANCE_ADMINISTRATIONS
DATE_EFFECTIVE_HIGH
The date the administration occurred


SUBSTANCE_ADMINISTRATIONS
DATE_EFFECTIVE_LOW
The date the administration occurred


SUBSTANCE_ADMINISTRATIONS
AVAILABLE_DATE
The point in time at which information




about this administration first became




available to a system reproducing this




administration. The availability date is




metadata describing the record, not the




administration.


SUBSTANCE_ADMINISTRATIONS
PERIOD
A time duration specifying as a




reciprocal measure of the frequency at




which the administration repeats


SUBSTANCE_ADMINISTRATIONS
PERIOD_TIME_UNIT_ID
The unit of measure of the period


SUBSTANCE_ADMINISTRATIONS
DURATION
The magnitude of the quantity




measured in terms of the unit of the




duration


SUBSTANCE_ADMINISTRATIONS
DURATION_TIME_UNIT_ID
The unit of measure specified for the




duration


SUBSTANCE_ADMINISTRATIONS
SOURCE_ID
The id provided by the source




document


SUBSTANCE_ADMINISTRATIONS
RESEARCH_SUBJECT_ID
The subject of the administration


SUBSTANCE_ADMINISTRATIONS
DATA_ENTERER
The person who entered the data


SUBSTANCE_ADMINISTRATIONS
MODIFIED_REASON
The reason for the modification


SUBSTANCE_ADMINISTRATIONS
MODIFIED_SUB_ADMINISTRATION_ID
The administration records that this




records modifies


SUBSTANCE_ADMINISTRATIONS
DEVICE_ID
The device that recorded the




administration


SUBSTANCE_ADMINISTRATIONS
INVESTIGATOR_ID
The investigator that recorded the




administration


SUBSTANCE_ADMINISTRATIONS
SERVICE_PROVIDER_ID
The service provided that recorded the




administration


SUBSTANCE_ADMINISTRATIONS
PLANNED_ADMINISTRATION_ID
The planned administration as specified




in the protocol


SUBSTANCE_ADMINISTRATIONS
TREATMENT_ID
The treatment that this observation is




within


SUBSTANCE_ADMINISTRATIONS
IS_CURRENT
If true the this record is the most




current
















TABLE 112







Study Summaries









Table Name
Entity/Column Name
Description





SUMMARIES
ENTITY
There are several attributes of the




study. Each attribute is used to describe




the study. It is expected that there




would be a controlled terminology to




limit the type (code) of the study




characteristics. Each code might have a




set of controlled terminology as well.




Nonetheless, for every attribute type,




the data type will be specified. This list




of Study Characteristics is currently




bound to the Characteristics identified




by the CT.gov trial registration data




specification.


SUMMARIES
SUMMARY_ID
Unique identifier


SUMMARIES
STUDY_CHARACTERISTIC_TYPE_ID
The type of study characteristics (e.g.;




blinding schema, intent, phase,




randomization, objectives, blinding




Schema, confidentiality, monitor




disease, intent, phase randomized




Indicator, populated description,




intervention, duration, study duration)


SUMMARIES
STUDY_MASTER_ID
The study


SUMMARIES
DATATYPE_ID
Based on the data type certain fields




will be populated. The data type




examples include, coded, physical




quantity, string, real


SUMMARIES
RESULT_REAL
Used when the data type is physical




quantity, ratio or real. Result in a




numeric value of the summary


SUMMARIES
RESULT_UNIT_ID
Used when the data type is physical




quantity or ratio. The unit of measure




of the result. The numeric value will be




located in the result_real.


SUMMARIES
RESULT_STRING
Used when the data type is string. The




result of the summary


SUMMARIES
RESULT_DATE_LOW
Used when the data type is date. The




result of the summary


SUMMARIES
RESULT_DATE_HIGH 
Used when the data type is date. The




result of the summary


SUMMARIES
RESULT_DENOM_REAL
Used when the data type is ratio. The




numeric denominator result of the




operation


SUMMARIES
RESULT_DENOM_UNIT_ID 
Used when the data type is ratio. The




unit of measure of the denominator of




the result of the observation


SUMMARIES
NEGATION
Explains results that are the opposite of




what is stated


SUMMARIES
SOURCE_ID
The id provided by the source




document
















TABLE 113







Supplies









Table Name
Entity/Column Name
Description





SUPPLIES
ENTITY
Provision of a material by an




investigator to the experimental unit.




The precise identification of the




product (route, dosage form, serial




numbers, etc.) is important. Most of the




detailed information about the Supply




should be represented by the product.


SUPPLIES
SUPPLY_ID
If true the this record is the most




current


SUPPLIES
SUPPLY_TYPE_ID
The type of supply - why is this needed


SUPPLIES
PRODUCT_ID
The product that is being supplied


SUPPLIES
ENCOUNTER_ID
The encounter where the supply




occurred


SUPPLIES
DATE_EFFECTIVE_HIGH
The date the supply occurred


SUPPLIES
DATE_EFFECTIVE_LOW
The date the supply occurred


SUPPLIES
DESCRIPTION
Description of the supply


SUPPLIES
EXPECTED_USE_HIGH
The period time over which the




supplied product is expected to be used.


SUPPLIES
EXPECTED_USE_LOW
The period time over which the




supplied product is expected to be used.


SUPPLIES
EXPECTED_USE_UNIT_ID
The unit of measure specified for the




expected use


SUPPLIES
DURATION
The magnitude of the quantity




measured in terms of the unit of the




duration


SUPPLIES
DURATION_TIME_UNIT_ID
The unit of measure specified for the




duration


SUPPLIES
SOURCE_ID
The id provided by the source




document


SUPPLIES
RESEARCH_SUBJECT_ID
The subject of the administration


SUPPLIES
DATA_ENTERER
The person who entered the data


SUPPLIES
MODIFIED_REASON
The reason for the modification


SUPPLIES
MODIFIED_SUPPY_ID
The supply records that this records




modifies


SUPPLIES
DEVICE_ID
The device that recorded the supply


SUPPLIES
INVESTIGATOR_ID
The investigator that recorded the




supply


SUPPLIES
SERVICE_PROVIDER_ID
The service provided that recorded the




supply


SUPPLIES
QUANTITY_UNIT_ID
The unit of measure specified for the




quantity


SUPPLIES
QUANTITY
The amount of product that is to be




supplied.


SUPPLIES
PLANNED_SUPPLY_ID
The planned supply as specified in the




protocol


SUPPLIES
TREATMENT_ID
The treatment that this supply is within


SUPPLIES
IS_CURRENT
If true the this record is the most




current
















TABLE 114







Supply types









Table Name
Entity/Column Name
Description





SUPPLY_TYPES
ENTITY
The type of supply - why is this needed


SUPPLY_TYPES
SUPPLY_TYPE_ID
Unique identifier


SUPPLY_TYPES
DESCRIPTION
Friendly name of identifier


SUPPLY_TYPES
CODE
Code from the coding system


SUPPLY_TYPES
CODE_SYSTEM
Code system of the code


SUPPLY_TYPES
CODE_SYSTEM_VERSION
Version of the code system version of




the code
















TABLE 115







Target Sites









Table Name
Entity/Column Name
Description





TARGET_SITES
ENTITY
The anatomical site or system that is




the focus of the planned or actual




activity. Most activity target sites are




implied by the activity type.


TARGET_SITES
TARGET_SITE_ID
Unique identifier


TARGET_SITES
DESCRIPTION
Friendly name of identifier


TARGET_SITES
CODE
Code from the coding system


TARGET_SITES
CODE_SYSTEM
Code system of the code


TARGET_SITES
CODE_SYSTEM_VERSION
Version of the code system version of




the code
















TABLE 116







Time Units









Table Name
Entity/Column Name
Description





TIME_UNITS
ENTITY
The unit of measure of 




time


TIME_UNITS
TIME_UNIT_ID
Unique identifier


TIME_UNITS
DESCRIPTION
Friendly name of identifier


TIME_UNITS
CODE
Code from the coding 




system


TIME_UNITS
CODE_SYSTEM
Code system of the code


TIME_UNITS
CODE_SYSTEM_VERSION
Version of the code 




system version of the code
















TABLE 117







Treatment Types









Table Name
Entity/Column Name
Description





TREATMENT_TYPES
ENTITY
Used to determine 




the type of the treat-




ment (e.g., screening,




pre-op, etc.)


TREATMENT_TYPES
TREATMENT_TYPE_ID
Unique identifier


TREATMENT_TYPES
NAME
Name of the 




treatment type
















TABLE 118







Treatments









Table Name
Entity/Column Name
Description





TREATMENTS
ENTITY
Studies are organized into discrete




units. This organization of the protocol




into discrete units is used for study




analysis and to describe the conduct of




the study. This organization is




accomplished through the treatments.




Note: Study cell and study segment are




both a treatment. Since every study




segment is contained wholly within one




epoch, at a minimum, in each Arm




there are at least as many treatments as




there are Epochs. The treatment has




two purposes: statistical analysis and




scheduling of planned activities. The




statistical analysis typically needs only




two levels of organization. The top




level of organization corresponds to




one Epoch. The schedule of planned




activities can require several levels of




organization. Nevertheless, the




statistical analysis organization and




schedule of planned activities




organization overlap. A treatment,




along with the recursive treatments,




represents the action plan. Treatments




can be a cell, segment, stage, phase,




period, cycle. Duration of treatments




can be calculated. When the treatment




refers to an epoch, then that treatment is




a cell (a cell as defined by CDISC's




Study Data Tabulation Model).


TREATMENTS
TREATMENT_ID
Unique identifier


TREATMENTS
TREATMENT_TYPE_ID
The type of treatment, e.g., study, study




cell, element, workflow node


TREATMENTS
EPOCH_ID
If the treatment is a study cell, then the




study cell belongs in one epoch


TREATMENTS
OBSERVATION_CRITERIA_ID
The treatment can have many blocking




(enter) or exit criteria


TREATMENTS
ASSIGNMENT_TYPE_ID
If an assignment occurs to this




treatment, is the assignment based on




randomization or observation.


TREATMENTS
SOURCE_ID
The identifier as provided by the source




documents


TREATMENTS
STUDY_DEFINITION_ID
The study the treatment belongs to


TREATMENTS
TITLE
A word or phrase by which a treatment




may be known among people. This is




not a formal identifier but rather a




human-recognizable common name.




Title will not always be used


TREATMENTS
ITERATION_LOW
The minimal number of repetitions of




the treatment


TREATMENTS
ITERATION_HIGH
The maximal number of repetitions of




the treatment. A value of negative 1




equals forever.


TREATMENTS
DESCRIPTION
Long description of the treatment


TREATMENTS
DURATION
The magnitude of the quantity




measured in terms of the unit of the




duration


TREATMENTS
DURATION_TIME_UNIT_ID
The unit of measure specified for the




duration
















TABLE 119







Treatment Arms










Entity/ 




Column



Table Name
Name
Description





TREATMENTS_ARMS
ENTITY
Intersection table to allow 




for the many to many 




relationship of a treatment 




in an arm


TREATMENTS_LOCATIONS
ENTITY
The location where the 




treatment occurs
















TABLE 120







Treatments Planned Subjects










Entity/




Column



Table Name
Name
Description





TREATMENTS_PLANNED_SUBJECTS
ENTITY
A planned subject 




can receive many 




treatments
















TABLE 121







Sub Treatments










Entity/




Column



Table Name
Name
Description





TREATMENTS_TREATMENTS
ENTITY
A mechanism to order 




the execution of the 




treatment planned 




activities


TREATMENTS_TREATMENTS
PARENT_ID
Parent treatment


TREATMENTS_TREATMENTS
CHILD_ID
The child treatment


TREATMENTS_TREATMENTS
SEQUENCE
The order the child 




treatment is executed









Alternative embodiments of the present invention can store patient information not linked to a study. The planned components can be used as a guideline for the best practices to treat a specified condition. The actual activities do not need to be linked to a study or a guideline. Even without a study or a guideline, embodiments of the present invention can be used to compare different treatments to determine which treatments work best on a population.
Also, a subset of the plurality or set of planned or actual activities may be the same in a plurality of different studies. For example, a blood pressure test in study 1 may be the same blood pressure test in study 2. Likewise, a subset of the plurality or set of assessments may be the same in a plurality of different studies.
The embodiment described above relates to an investigational drug. However, the present invention may be used with an investigational product, which may be an investigational compound (e.g., pharmaceutical drug), an investigational device, or an investigational diagnostic device, agent, or test.
The present invention may be implemented with any combination of hardware and software. If implemented as a computer-implemented apparatus, the present invention is implemented using means for performing all of the steps and functions described above.
When implemented in software, the software code can be executed on any suitable processor or collection of processors, whether provided in a single computer or distributed among multiple computers.
The present invention can also be included in an article of manufacture (e.g., one or more computer program products) having, for instance, computer readable storage media. The storage media has computer readable program code stored therein that is encoded with instructions for execution by a processor for providing and facilitating the mechanisms of the present invention. The article of manufacture can be included as part of a computer system or sold separately.
The storage media can be any known media, such as computer memory, one or more floppy discs, compact discs, optical discs, magnetic tapes, flash memories, circuit configurations in Field Programmable Gate Arrays or other semiconductor devices, or other tangible computer storage medium. The storage media can be transportable, such that the program or programs stored thereon can be loaded onto one or more different computers or other processors to implement various aspects of the present invention as discussed above.
The computers used herein may be embodied in any of a number of foams, such as a rack-mounted computer, a desktop computer, a laptop computer, or a tablet computer. Additionally, a computer may be embedded in a device not generally regarded as a computer but with suitable processing capabilities, including a Personal Digital Assistant (PDA), a smart phone or any other suitable portable, mobile, or fixed electronic device.
The computer may have one or more input and output devices. These devices can be used, among other things, to present a user interface. Examples of output devices that can be used to provide a user interface include printers or display screens for visual presentation of output and speakers or other sound generating devices for audible presentation of output. Examples of input devices that can be used for a user interface include keyboards, and pointing devices, such as mice, touch pads, and digitizing tablets. As another example, a computer may receive input information through speech recognition or in other audible format.
Such computers may be interconnected by one or more networks in any suitable form, including as a local area network or a wide area network, such as an enterprise network or the Internet. Such networks may be based on any suitable technology and may operate according to any suitable protocol and may include wireless networks, wired networks or fiber optic networks.
The various methods or processes outlined herein may be coded as software that is executable on one or more processors that employ any one of a variety of operating systems or platforms. Additionally, such software may be written using any of a number of suitable programming languages and/or programming or scripting tools, and also may be compiled as executable machine language code or intermediate code that is executed on a framework or virtual machine.
The terms “program” or “software” are used herein in a generic sense to refer to any type of computer code or set of computer-executable instructions that can be employed to program a computer or other processor to implement various aspects of the present invention as discussed above. The computer program need not reside on a single computer or processor, but may be distributed in a modular fashion amongst a number of different computers or processors to implement various aspects of the present invention.
Computer-executable instructions may be in many forms, such as program modules, executed by one or more computers or other devices. Generally, program modules include routines, programs, objects, components, data structures, and the like, that perform particular tasks or implement particular abstract data types. The functionality of the program modules may be combined or distributed as desired in various embodiments.
Data structures may be stored in computer-readable media in any suitable form. For simplicity of illustration, data structures may be shown to have fields that are related through location in the data structure. Such relationships may likewise be achieved by assigning storage for the fields with locations in a computer-readable medium that conveys relationship between the fields. However, any suitable mechanism may be used to establish a relationship between information in fields of a data structure, including through the use of pointers, tags or other mechanisms that establish relationship between data elements.
Preferred embodiments of the present invention may be implemented as methods, of which examples have been provided. The acts performed as part of the methods may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though such acts are shown as being sequentially performed in illustrative embodiments.
It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention.

## Claims

1. A computer for processing data from a plurality of studies of investigational products in a manner that allows data from one study to be compared to data from one or more other studies, wherein each study includes a set of actual activities, the computer comprising:
(a) memory configured to store an operating system, the operating system including an object-oriented database engine;
(b) a database schema maintained by the object-oriented database engine of the operating system, the database schema having a plurality of uniquely defined database objects, the uniquely defined database objects including for each study of an investigational product a set of objects that store the set of actual activities, wherein the set of actual activities for each study of an investigational product differ from one another; and
(c) a database that is populated with data associated with the set of actual activities,
wherein the set of objects that store the set of actual activities for each study of an investigational product share common attributes and relationships,
wherein each actual activity has an associated data type, and the associated data type is the same for different studies of investigational products, and
wherein the set of objects are used to allow the data from one study to be compared to the data from one or more other studies.

2. The computer of claim 1 wherein the investigational product is an investigational compound.

3. The computer of claim 1 wherein the investigational product is an investigational device, or an investigational diagnostic device, agent, or test.

4. The computer of claim 1 wherein a subset of the set of actual activities is the same in a plurality of different studies of investigational products.

5. A computer program product for processing data from a plurality of studies of investigational products in a manner that allows data from one study to be compared to data from one or more other studies, wherein each study includes a set of actual activities, the computer program product comprising non-transitory computer-readable media encoded with instructions for execution by a processor to perform a method comprising:
(a) configuring an operating system that includes an object-oriented database engine;
(b) maintaining a database schema by the object-oriented database engine of the operating system, the database schema having a plurality of uniquely defined database objects, the uniquely defined database objects including for each study of an investigational product a set of objects that store the set of actual activities, wherein the set of actual activities for each study of an investigational product differ from one another; and
(c) maintaining a database that is populated with data associated with the set of actual activities,
wherein the set of objects that store the set of actual activities for each study of an investigational product share common attributes and relationships, and
wherein each actual activity has an associated data type, and the associated data type is the same for different studies of investigational products, and
wherein the set of objects are used to allow the data from one study to be compared to the data from one or more other studies.

6. The computer program product of claim 5 wherein the investigational product is an investigational compound.

7. The computer program product of claim 5 wherein the investigational product is an investigational device, or an investigational diagnostic device, agent, or test.

8. The computer program product of claim 5 wherein a subset of the set of actual activities is the same in a plurality of different studies of investigational products.

9. A computer for processing data from a study of an investigational product, wherein each study includes (i) a plurality of planned activities, and (ii) a plurality of actual activities, the computer processing the data in a manner that allows the plurality of planned activities to be compared to the plurality of actual activities, the computer comprising:
(a) memory configured to store an operating system, the operating system including an object-oriented database engine;
(b) a database schema maintained by the object-oriented database engine of the operating system, the database schema having a plurality of uniquely defined database objects, the uniquely defined database objects including for each study of an investigational product:
(i) a first set of objects that store the plurality of planned activities,
(ii) a second set of objects that store the plurality of actual activities, and

(c) a database that is populated with data associated with the plurality of planned activities and the actual activities,
wherein the first set of objects that store the plurality of planned activities for the study of an investigational product share common attributes and relationships, and the second set of objects that store the plurality of actual activities for the study of an investigational product share common attributes and relationships, and
wherein the first and second set of objects are used to allow the plurality of planned activities to be compared to the plurality of actual activities.

10. The computer of claim 9 wherein the study of an investigational product further includes a study definition that includes the plurality of planned activities.

11. The computer of claim 9 wherein the investigational product is an investigational compound.

12. The computer of claim 9 wherein the investigational product is an investigational device, or an investigational diagnostic device, agent, or test.

13. The computer of claim 9 wherein a subset of the plurality of planned activities and a subset of the plurality of actual activities is the same in a plurality of different studies of investigational products.

14. A computer program product for processing data from a study of an investigational product in a manner that allows for data comparison, wherein each study includes (i) a plurality of planned activities, and (ii) a plurality of actual activities, the computer program product processing the data in a manner that allows the plurality of planned activities to be compared to the plurality of actual activities, the computer program product comprising non-transitory computer-readable media encoded with instructions for execution by a processor to perform a method comprising:
(a) configuring an operating system that includes an object-oriented database engine;
(b) maintaining a database schema by the object-oriented database engine of the operating system, the database schema having a plurality of uniquely defined database objects, the uniquely defined database objects including for each study of an investigational product:
(i) a first set of objects that store the plurality of planned activities, and
(ii) a second set of objects that store the plurality of actual activities; and

(c) maintaining a database that is populated with data associated with the plurality of planned activities and the plurality of actual activities,
wherein the first set of objects that store the plurality of planned activities for the study of an investigational product share common attributes and relationships, and the second set of objects that store the plurality of actual activities for the study of an investigational product share common attributes and relationships, and
wherein the first and second set of objects are used to allow the plurality of planned activities to be compared to the plurality of actual activities.

15. The computer program product of claim 14 wherein the study further includes a study definition that includes the plurality of planned activities.

16. The computer program product of claim 14 wherein the investigational product is an investigational compound.

17. The computer program product of claim 14 wherein the investigational product is an investigational device, or an investigational diagnostic device, agent, or test.

18. The computer program product of claim 14 wherein a subset of the plurality of planned activities and a subset of the plurality of actual activities is the same in a plurality of different studies.

19. A computer for processing data from a plurality of studies of investigational products in a manner that allows data from one study to be compared to data from one or more other studies, wherein each study includes (i) a plurality of planned activities, and (ii) a plurality of actual activities, the computer comprising:
(a) memory configured to store an operating system, the operating system including an object-oriented database engine;
(b) a database schema maintained by the object-oriented database engine of the operating system, the database schema having a plurality of uniquely defined database objects, the uniquely defined database objects including for each study of an investigational product:
(i) a first set of objects that store the plurality of planned activities,
(ii) a second set of objects that store the plurality of actual activities, and

(c) a database that is populated with data associated with the plurality of planned activities and the plurality of actual activities,
wherein the first set of objects that store the plurality of planned activities and the second set of objects that store the plurality of actual activities for each study of an investigational product share common attributes and relationships, and
wherein each planned activity and each actual activity has an associated data type, and the associated data type is the same for different studies of investigational products, and
wherein the first and second set of objects are used to allow the data from one study to be compared to the data from one or more other studies.

20. The computer of claim 19 wherein the study of an investigational product further includes a study definition that includes the plurality of planned activities.

21. The computer of claim 19 wherein the investigational product is an investigational compound.

22. The computer of claim 19 wherein the investigational product is an investigational device, or an investigational diagnostic device, agent, or test.

23. The computer of claim 19 wherein a subset of the plurality of planned activities and a subset of the plurality of actual activities is the same in a plurality of different studies of investigational products.

24. A computer program product for processing data from a plurality of studies of investigational products in a manner that allows data from one study to be compared to data from one or more other studies, wherein each study includes (i) a plurality of planned activities and (ii) a plurality of actual activities, the computer program product comprising non-transitory computer-readable media encoded with instructions for execution by a processor to perform a method comprising:
(a) configuring an operating system that includes an object-oriented database engine;
(b) maintaining a database schema by the object-oriented database engine of the operating system, the database schema having a plurality of uniquely defined database objects, the uniquely defined database objects including for each study of an investigational product:
(i) a first set of objects that store the plurality of planned activities, and
(ii) a second set of objects that store the plurality of actual activities; and

(c) maintaining a database that is populated with data associated with the plurality of planned activities and the plurality of actual activities,
wherein the first set of objects that store the plurality of planned activities and the second set of objects that store the plurality of actual activities for each study of an investigational product share common attributes and relationships, and
wherein each planned activity and each actual activity has an associated data type, and the associated data type is the same for different studies of investigational products, and
wherein the first and second set of objects are used to allow the data from one study to be compared to the data from one or more other studies.

25. The computer program product of claim 24 wherein the study of an investigational product further includes a study definition that includes the plurality of planned activities.

26. The computer program product of claim 24 wherein the investigational product is an investigational compound.

27. The computer program product of claim 24 wherein the investigational product is an investigational device, or an investigational diagnostic device, agent, or test.

28. The computer program product of claim 24 wherein a subset of the plurality of planned activities and the plurality of actual activities is the same in a plurality of different studies of investigational products.

29. A computer for processing data from a plurality of studies of investigational products in a manner that allows data from one study to be compared to data from one or more other studies, wherein each study includes (i) a plurality of actual activities; and (ii) a plurality of assessments, the computer comprising:
(a) memory configured to store an operating system, the operating system including an object-oriented database engine;
(b) a database schema maintained by the object-oriented database engine of the operating system, the database schema having a plurality of uniquely defined database objects, the uniquely defined database objects including for each study of an investigational product:
(i) a first set of objects that store the plurality of actual activities, and
(iii) a second set of objects that store the plurality of assessments; and

(c) a database that is populated with data associated with the plurality of actual activities and the plurality of assessments,
wherein the first set of objects that store the plurality of actual activities and the second set of objects that store the plurality of assessments for each study of an investigational product share common attributes and relationships, and
wherein each actual activity and assessment has an associated data type, and the associated data type is the same for different studies of investigational products, and
wherein the first and second set of objects are used to allow the data from one study to be compared to the data from one or more other studies.

30. The computer of claim 29 wherein the investigational product is an investigational compound.

31. The computer of claim 29 wherein the investigational product is an investigational device, or an investigational diagnostic device, agent, or test.

32. The computer of claim 29 wherein a subset of the plurality of actual activities is the same in a plurality of different studies of investigational products.

33. A computer program product for processing data from a plurality of studies of investigational products in a manner that allows data from one study to be compared to data from one or more other studies, wherein each study includes (i) a plurality of actual activities; and (ii) a plurality of assessments, the computer program product comprising non-transitory computer-readable media encoded with instructions for execution by a processor to perform a method comprising:
(a) configuring an operating system that includes an object-oriented database engine;
(b) maintaining a database schema by the object-oriented database engine of the operating system, the database schema having a plurality of uniquely defined database objects, the uniquely defined database objects including for each study of an investigational product:
(i) a first set of objects that store the plurality of actual activities, and
(iii) a second set of objects that store the plurality of assessments; and

(c) maintaining a database that is populated with data associated with the plurality of actual activities and the plurality of assessments,
wherein the first set of objects that store the plurality of actual activities and the second set of objects that store the plurality of assessments for each study of an investigational product share common attributes and relationships, and
wherein each actual activity and assessment has an associated data type, and the associated data type is the same for different studies of investigational products, and
wherein the first and second set of objects are used to allow the data from one study to be compared to the data from one or more other studies.

34. The computer program product of claim 33 wherein the investigational product is an investigational compound.

35. The computer program product of claim 33 wherein the investigational product is an investigational device, or an investigational diagnostic device, agent, or test.

36. The computer program product of claim 33 wherein a subset of the plurality of actual activities is the same in a plurality of different studies of investigational products.