Abstract:
Medical and other research organizations, sites within those organizations, and physicians practicing at those sites register in an online database. The company providing the database posts a description of a clinical trial opportunity or other research opportunity. The company can search and match for physicians with research opportunities, or the physicians can browse the list of opportunities. Once it is determined who will perform the research and awarded a contract, performance data are collected at 30-day intervals over the life of the trial for computation of benchmarks. The benchmarks from one physician are compared anonymously to those from other physicians participating in the same opportunity.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention is directed to a system and method for evaluation of the performance and progress of research trials and more specifically to such a system and method, which provide benchmark metrics in real time.  
         DESCRIPTION OF RELATED ART  
         [0002]    In clinical trials for pharmaceuticals and the like, data must be taken over an extended period. For example, at intervals of time, typically 30 days, data must be taken on the number of patients who are participating in the trial, the number who have dropped out, the queries per patient, and the like.  
           [0003]    However, the data are typically collected and tabulated by pharmaceutical companies to manage their project timeliness. Such information is rarely shared with the physicians and health-care professionals conducting the research studies for purposes of understanding how they are performing, how other research sites are doing and/or learning from other clinicians participating in the study about how to improve their study management and performance. Currently no electronic mechanism exists that systematically, and automatically provides clinicians the ability to interact with the physicians and health-care professionals conducting the research studies for purposes of understanding how they are performing, how other research sites are doing and or learning from other clinicians participating in the study about how to improve their study management and performance. Currently no electronic mechanism exists that systematically and automatically provides clinicians and/or pharmaceutical sponsors with the ability to obtain interactive, real-time benchmarks and with those benchmarks better assess physician capabilities for matching physicians and research sites and with those data better assess physician capabilities for matching physicians and research sites for future clinical trials.  
           [0004]    One Internet-based technique for matching experts in the biological sciences with those needing their services is disclosed in WO 01/29708, published Apr. 26, 2001. That technique provides for matching based on qualifications and times of availability as well as payment. However, once the experts and their customers are matched, there is no evaluation of the work, which the former do for the latter.  
         SUMMARY AND OBJECTS OF THE INVENTION  
         [0005]    It will be readily apparent from the above that a need exists in the art for an online, interactive evaluation of research performance. It is therefore a primary object of the invention to collect data concerning the progress of research and to provide an evaluation based on the collected data.  
           [0006]    It is another object of the invention to provide an interactive, automated, online technique for doing so.  
           [0007]    It is a further object of the invention to provide such an evaluation based on data collected at various time intervals.  
           [0008]    It is a still further object of the invention to allow comparative evaluations among various trials.  
           [0009]    It is a still further object of the invention to allow comparative evaluations without divulging the identity of one trial to researchers participating in another.  
           [0010]    To achieve the above and other objects, the present invention is directed to an online, automated technique for collecting data not only for clinical trials but for other types of medical research including: marketing research, outcomes studies, disease management, etc. This type of medical research information would be information used to support the post approval product launches, marketing, product positioning, business development opportunities including licensing from clinical trials at intervals of, e.g., 30 days and for performing automated, online evaluations based on the data. The evaluations can be presented in textual or graphical formats. A common server can be used to collect data from multiple trials, with the appropriate protection of the data from each trial for privacy purposes. The comparisons, e.g., for cost per patient, can be presented anonymously; for example, the figures for the highest and lowest costs per patient can be given without identifying the sources for those figures.  
           [0011]    Users register for the service as organizations. The system will then ask the user to register all sites and physicians that fall under the umbrella of the organization. If a physician is a solo practitioner, the physician still must complete all three profiles, although some information may be duplicated, since each profile focuses on collecting differing information. During the registration process, each user provides information to be entered into a database. For a physician, the information concerns the physician&#39;s own practice and the site, if any, at which the physician is an administrator. For a site, the information concerns such things as the facilities at the site and the physicians practicing at the site. For an organization, the information concerns such things as the type of organization and the sites and physicians within the organization.  
           [0012]    A listing of a clinical trial opportunity (blinded synopsis) or other research opportunity (blinded synopsis) with an accompanying protocol synopsis specific questionnaire (SQQ) is posted on the website. The listing is categorized to allow browsing by prospective researchers who are members. In addition, the service can search the database to find suitable physicians, sites or organizations who preliminarily match the criteria the sponsor has provided to the service and then select which ones are to be contacted about the clinical trial opportunity. That occurs by cross-referencing project requirements with general information about the sites, physicians and organizations. Contacting members about opportunities occurs via e-mail or facsimile to invite them to consider the opportunity. Following the researchers&#39; completion of any new data not currently in the database and contained in the SQQ, the research electronically submits the completed SQQ via email to the service. The service summarizes all the information across all completed SQQ&#39;s for the specific research opportunity and forwards qualified and matched researchers to the sponsor. The sponsor then selects which research provided by the service they will select for the clinical trial.  
           [0013]    Once a researcher is selected for the study, information about the study is entered into the database, e.g., at the beginning and end of the study and at 30-day intervals or less therebetween. The information concerns such things as the number of patients who have signed up and the number who have dropped out. Thus, benchmarks can be computed over time.  
           [0014]    Study (clinical trial/protocol) specific benchmarks from one researcher, site and or organization can be anonymously compared with those from other researchers, sites and/or organizations. In one example of a comparison, four values of a benchmark are given: the highest and lowest values from the researcher, site and organization participating in the study any study, the median from all researchers, sites and/or organizations, and the actual value from the researcher, site and/or organization with which the person viewing the results is linked in which the person viewing the results is participating. The identities of the other researchers, sites and/or organizations from which the information is provided are not given, thus preserving confidentiality. The user can thus see how their researcher, site and or organization performance results for the study compares with other researcher, site and/or organization performance results for the study and can use that information, e.g., to see where efficiency can be improved, budgets should be reallocated, patients that qualify for the study can be found, training is required or to make the case for an increase in the research budget.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0015]    A preferred embodiment of the present invention will be set forth in detail with reference to the drawings, in which:  
         [0016]    [0016]FIG. 1 shows a hardware architecture on which the preferred embodiment can be implemented;  
         [0017]    FIGS.  2 ,  2 A- 2 I,  3 ,  3 A- 3 D,  4  and  4 A- 4 C show flow charts and screen shots of the registration and data inputting process for new users;  
         [0018]    [0018]FIGS. 5A and 5B show a physician registration page;  
         [0019]    [0019]FIG. 6 shows a search page;  
         [0020]    [0020]FIG. 7 shows a search result page;  
         [0021]    [0021]FIG. 8 shows a flow chart of the processes involved in posting a CTO or ORO description;  
         [0022]    FIGS.  8 A- 8 E show screen shots of the processes of FIG. 8;  
         [0023]    [0023]FIG. 9 shows a merge page;  
         [0024]    [0024]FIGS. 10 and 11 show pages used in collecting progress data;  
         [0025]    [0025]FIGS. 12 and 13 show pages used in displaying benchmark data; and  
         [0026]    [0026]FIG. 14 shows a flow chart of operation of an enhancement to the service which allows physicians to obtain information on fees.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0027]    A preferred embodiment of the present invention will now be set forth in detail with reference to the drawings, in which like reference numerals refer to like elements or process steps throughout.  
         [0028]    [0028]FIG. 1 shows an example of a hardware architecture on which the preferred embodiment can be implemented. The design of the hardware architecture has been selected to follow the industry-standard N-tier architecture, separating site navigation and design from stored procedures and data. In that way, one part of the site can be redesigned without breaking another part of the site. For instance, the HTML which provides the user interface can be changed without affecting the stored procedures and tables of the database.  
         [0029]    [0029]FIG. 1 shows such a hardware architecture  100 . Client devices  102 , which can be microcomputers or any other devices capable of communicating over the Internet, connect via any suitable connections  104 , such as dial-up or cable modem connections, to the Internet  106 , and thence via a full-time Internet connection  108  to a Web server  110 . The client devices are used by physicians, research sponsors, research sites such as hospitals, and others participating in the operations of the preferred embodiment. The Web server  110  provides business services, such as site navigation and design, and is connected via a full-time dedicated connection  112  to a database server  114  storing the stored procedures and database tables. Thus, the client devices  102  access the stored procedures and database tables in the database server  114  only through the Web server  110 . It is preferable to implement the Web server  110  and the database server  114  on separate, dedicated machines to facilitate backups and restarts with a minimum of disruption. The Web server  110  implements interactive HTML pages through known technologies, such as CGI or ASP. The database stored in the database server  114  is populated when physicians and organizations register and provide the information required for registration. As is known in the art, the Web server  110  provides persons accessing it from client devices  102  with several options, including physician registration and organization registration.  
         [0030]    A user registers as an organization; physician registration and site registration are part of organizational registration. As noted above, a solo practitioner still registers as an organization. The organizational registration has two parts, the first part resulting in temporary status and the second part resulting in active status.  
         [0031]    [0031]FIG. 2 shows an overview of organization registration. At step  202 , the user is prompted for the name and address of the organization and for the type of organization (see the Web page of FIG. 2A). The latter is preferably selected through check boxes, so that multiple choices may be selected, although it may be selected through a drop-down menu or radio buttons if only one choice is allowed. At step  204 , once that information is received, a temporary user identification and password are generated and provided to the user (or the user can select them; see FIG. 2B). The user is then allowed to view more detailed descriptions of the research opportunities; however, if any particular opportunity is selected, the user must proceed to the second part of the registration.  
         [0032]    That second part begins at step  206 , in which the user is prompted to complete an organizational profile (see FIG. 2C). When the User is completing the site location section of the organization profile, the first page of the organization profile asks “how many site locations” at step  208 , and this automatically generates, at step  210 , a table (see FIG. 2D) on page two of the organization profile with the necessary number of rows for all site locations. The User must complete this table in order to advance to page three of the organization profile; that will generate the correct number of site profiles. At step  212 , the user completes a physician profile (see FIG. 2E) for each physician within the organization, until it is determined at step  214  (see FIG. 2F) that profiles have been completed for all physicians within the organization; step  214  can be performed like step  210 . Identifications and passwords are generated for the organization as a whole, for each site, and for each physician at steps  216 ,  218  and  220 , respectively (see FIG. 2G). At step  222 , it is indicated in the database that the organization&#39;s status is that of an active member (see FIG. 2H). At step  224 , the identifications and passwords are sent to the organization. At step  226 , a responsible person at the organization has the option to change the identification and password for the organization (see FIG. 2I). The organization representative has the ability to change any data about the organization, sites or physicians and has complete access to all three profiles. The representative cannot add further sites or physicians or edit the name of a physician.  
         [0033]    [0033]FIG. 3 shows an overview of the physician registration process of step  212 . At step  302  (see FIG. 3A), the Web server asks whether the physician is an administrator at the site at which the physician works. If it is determined at step  304  that the physician has answered in the affirmative, the physician is prompted at step  306  (see FIG. 3B) for information about the site, in a manner which will be described in detail below. If not, the physician is prompted at step  308  for the name of an administrator at that site. Either way, the physician&#39;s information is taken in a physician information form at step  310  (see FIG. 3C). A user identification (ID) and password (PW) are generated for the physician at step  312  (see FIG. 3D).  
         [0034]    [0034]FIG. 4 shows an overview of the site registration of step  210 . The number of sites input by the user is received at step  402  (see FIG. 4A). As noted above, a table of site locations, having a sufficient number of rows, is generated at step  404  (see FIG. 4B). The user completes the table, including information for each site, at step  406  (see FIG. 4C).  
         [0035]    The data entry forms will now be described. In general, a data entry form can be implemented in HTML as one page or several; if it is implemented in several pages, each page ends with “Next Page” (or if the last page of the form “Submit”), “Discard Changes and Exit” or “Save Changes and Exit” options. Also, the same forms can be used to add information about new users and to update information for existing users.  
         [0036]    [0036]FIG. 5A shows the first page of the physician&#39;s form. The first page  502  includes an area  504  for contact information, an area  506  for medical licensing and DEA information, and an area  508  in which the physician can identify specialties through drop-down menus. Other information, such as professional affiliations with one or more medical schools and hospitals, can be solicited here. There are also “Next Page” (or if the last page of the form “Submit”), “Main Page” and “Save Changes and Exit” buttons  510 ,  512  and  513 , as mentioned above.  
         [0037]    [0037]FIG. 5B shows a subsequent page  514  of the physician&#39;s form. As shown in FIG. 5B, the physician is asked about experience as a principal investigator in a clinical trial. Detailed experience on each clinical trial can be solicited in further pages, as well as information on any FDA or sponsor audit that the physician or the site has undergone, any administrative roles that the physician plays at the site, any articles or presentations in which the physician is named as an author, and any organizations and associations in which the physician is actively involved.  
         [0038]    The pages requesting organization and site information are similar. In addition, the organization pages request the type of organization, while the site pages request what facilities the site has, among other things. Pages can also be provided to transfer a physician from one site or organization to another or to transfer a site from one organization to another. This function is accessible solely to employees of the service, not registered users.  
         [0039]    The administrator of the database server  114  can accept the information as given or can take various steps to verify it. For example, the administrator can verify that a given facsimile number or e-mail address words, check a given medical license number, or interview either the person submitting the information or those persons named as references.  
         [0040]    Once all of the data concerning participating physicians, organizations, and sites have been entered into the database, the database can be searched. FIG. 6 shows a search page for searching for physicians. The search page  600  uses text boxes and drop-down menus, although other suitable interface elements can be used as needed. In any text box, wildcard searching can be allowed.  
         [0041]    Physicians can be searched by name, site, organization, or any combination of the three by use of the text boxes  602 ,  604 ,  606 . The drop-down menu  608  allows the search to be conducted for physicians who are members, non-members, or either. The person conducting the search can select a state through a drop-down menu  610  or a region through a drop-down menu  612 . A specialty can be selected through a drop-down menu  614 . Key words can be entered in a text box  616 . The page  600  can be designed to include any other search criteria, such as those relating to clinical trial experience. Once all of the search criteria are entered, the user clicks on the “Find Physicians” button  618 .  
         [0042]    Clicking on the “Find Physicians” button  618  causes the database server  114  to search for physician records matching the search criteria. The database server  114  passes the search results to the Web server  110  which formats them as shown in FIG. 7. The search results page  700  shows the search results in the form of a table  702 . At the far left is a select column  704 , which allows the user to select individual physicians for further consideration or to select all physicians through a “Select all” check box  706 . The name column  708  lists the physicians by name, with links to their profiles in the database. The specialty column  710  gives each physician&#39;s specialty. The organization column  712  and the site column  714  identify the organization and site, respectively, with which each physician is associated and include links to those organizations&#39; and sites&#39; profiles. A telephone number column  716  and a facsimile number column  717  give that information for each physician. The membership status column  718  identifies each physician as a member or non-member. The CTO column  720  and the ORO column  722  list CTO&#39;s and ORO&#39;s, respectively, with which the physician is or has been involved. Columns can be sorted by clicking on the name of the column. An indicator  726  identifies the number of physicians who have matched the query. The merge buttons  728  and  730  allow the user to merge the records for the selected physicians with a CTO or ORO in a manner to be explained below.  
         [0043]    An employee of the service can enter a CTO or ORO as shown in FIG. 8. At step  802 , the following are selected through drop-down menus or other suitable interface elements (see FIG. 8A): the specialty concerned (e.g., urology), the estimated number of patients, and the duration. At step  804 , the following are input as free-form text (see FIG. 8B): a descriptive title of the study, one or more inclusion criteria for patients (e.g., male patient aged 40-85 years), one or more exclusion criteria for patients (e.g., no previous prostatic surgery within two weeks of base line), and a per-patient budget (this can be indicated as “to be negotiated”). The criteria can also be selected through drop-down menus, in which case there will be an option to add criteria not appearing in the menus. The criteria can also be assigned a sorting order. Through a Design SQQ/PQQ Interface, the relevant SQQ or PQQ is designed and posted on the web at step  806  (see FIG. 8C). A number is manually assigned at step  808  (see FIG. 8D). The opportunity can be made viewable to network members only by an employee of the service at step  810  (see FIG. 8E). The CTO or ORO can be made viewable to persons viewing the organization&#39;s or site&#39;s profile or in a list sorted by specialty; preferably, both are done.  
         [0044]    Once the CTO or ORO is entered, the search results from FIG. 7 can be merged into the CTO or ORO. Once the button  728  or  730  is clicked, the merge page  902  or  904  in the merge area  900  of FIG. 9 appears. The user can select the Merge CTO or Merge ORO  902  or  904  and click the “Merge” button  906  or may cancel by closing the window. If the “Merge” button  906  is clicked, all of the selected search results from FIG. 7 are linked to the description of the CTO or ORO in the database. Checking for duplicate records is done automatically.  
         [0045]    The physicians, organizations, or sites merged into the listing can be invited to consider the CTO or ORO. Since anyone found in the search results will have provided some contact information, the invitation can be made by e-mail, facsimile, or any other suitable channel.  
         [0046]    Thus, the service (or, in an alternative embodiment, a sponsor of a CTO or ORO) can initiate contact with a physician, organization or site which may be suited to conduct that CTO or ORO, as described above with reference to FIG. 9. Either way, the questionnaire is completed and returned to the sponsor. The sponsor considers the questionnaire and can send a person to interview the physician or otherwise visit the organization or site at which the trial or other research would take place. A Web page can be provided to indicate the reasons why any particular physician, organization or site was accepted or declined. That Web page is accessible only by employees of the service or network members who have registered to use the system.  
         [0047]    Once a physician, organization or site is selected to conduct the trial, data are collected for benchmarking. General (industry) benchmarks include the following: revenue per primary investigator per year, patients enrolled per number of coordinator FTE&#39;s, average revenue per patient, distribution of revenue by type, average enrollment as a percentage of goal, split of patient recruitment between in-house and advertised, average number of protocols per year, average number of years in clinical research, percentage of studies through third party, percentage of studies directly from CRO or sponsor, number of sponsors with which a particular physician, site or organization has worked, and number of CRO&#39;s with which a particular physician, site or organization has worked. Benchmarks specific to a particular study include the following: time to first patient enrolled, total patients enrolled after the first thirty days, actual enrollment as a percentage of the enrollment goal, per-patient budget, number of queries per patient, enrollment as a percentage of total patients screened, and elapsed time from notification of award of study to initiation visit. Data entered into the Web Form (Site Status Summary, or SSS) are used to compute the benchmarks specific to a particular study. Those data are collected on a per-protocol basis, are specific to that protocol and are not stored for future protocols. On the other hand, information collected in the profiles can be used to update the SQQ/PQQ.  
         [0048]    Examples of Web pages for taking data associated with a particular study are shown in FIGS. 10 and 11 as  1000  and  1100 , respectively. The page  1100  is only partially shown, since the data are taken not simply at the end of  30  days, but rather at the end of every  30 -day interval until the end of the study; for instance, the page  1100  may ask for the number of patients screened after  720  days, etc. At the end of the study, data may be collected, such as the date of the study close-out visit and the number of queries generated.  
         [0049]    The benchmarks are calculated automatically by the system. The more data inputted, the more an organization can access. They do not have to wait until the study is over until they can view benchmarks, but as soon as the relevant data are input the benchmark is viewable. Once all of the data are input and the study is concluded, or once the data currently available are input if benchmarking during the study is required, benchmarking can be performed using straightforward calculations on the data. Two examples of data outputs are shown; those skilled in the art will recognize that many other types of data outputs can be provided as needed.  
         [0050]    [0050]FIG. 12 shows a bar chart  1200  in which the total budget per patient is broken down into overhead, procedure and lab fees, the study coordinator, and the investigator fees. FIG. 13 shows a bar chart  1300  showing a particular benchmark by its value in the user&#39;s study compared to its high, low, and average values from among all organizations participating in the same opportunity monitored by the database server  114 . The identities of the other organizations are not identified. Each of the bars of the bar chart  1300  can be broken up like the bar in the bar chart  1200 .  
         [0051]    The benchmarks can be displayed to the sponsor of the study, the physician, site or organization conducting the study, or both. Non-numerical information, such as the identities of the physicians involved in the study and information about them, can also be reported.  
         [0052]    An enhancement to the service provides a customizable search page for the “study budget project” where physicians can search for a price range for their service. The search is intuitive enough to allow physicians to select predetermined criteria to focus their search. Physicians will also be able to download their study budget information in a standard template usable in a spreadsheet program (e.g., Microsoft Excel).  
         [0053]    At step  1402 , a study budget system is provided, which is a separate module from the service previously described. At step  1404 , the user logs in. Members will pay a yearly license fee, billed monthly. Existing users will be able to retrieve their user name and password information by entering their e-mail address. If the system determines at step  1406  that the user is a new user, or is an existing member using the system for the first time, the user will be required to complete an activation form at step  1408 . On confirmation of the user&#39;s credit card, the user will receive a welcome message and information about their subscription via e-mail.  
         [0054]    At step  1410 , the user will choose from standard study questions about that user&#39;s procedure type, which sets the parameters for the query. At step  1412 , the user receives high, average, and low fees for the selected query.  
         [0055]    At step  1414 , a study budget template is provided in order to be populated with the user&#39;s information. The study budget template provides automatic calculations and a printable template. At step  1416 , on completion of the template, the information is updated to the database.  
         [0056]    While the disclosure set forth above is believed to provide an enabling disclosure of the present invention and a best mode for carrying out the present invention, an administrative-level user&#39;s guide will now be set forth for the sake of completeness. For ease of understanding, the user&#39;s guide is organized in tabular form.  
                                       Question   Topic   Response                   What happens   New Site   If it is completed on-line,       when a site   Applications   E-mail Copy automatically goes to the       completes their   Completing   service. The Site Recruiter then logs onto       application on-   Reference   www.rapidtrials.com/orge.asp       line or hard   Check   They select the organization name from       copy?   Information   the drop down list and hit EDIT           on   They move using ALT + N or Next Page           Rapidtrials   to the last page of the profile           Activating a   The last page lists the references           New Site   They also list whether the references were:               “outstanding”               “Average”               “Unfavorable”               Once the reference checks are done,               these are changed as appropriate               The date the contract is signed is inputted               into the first page, as well as some other               contract information.               Once the site is ready to be a member of               the network the site recruiter goes to the               first page of the organization profile, by               going to www.rapidtrials.com/orge.asp,               members admin, selecting the org name               from the drop down and hitting EDIT               Members admin page drop down list of               organizations If the organization is in               black it is an active member of the net-               work, if the org is in blue or any other               color you can check the status by going to               Edit and looking at the status drop down               halfway down page one of the organi-               zation profile.               Halfway down the first page is a status               drop down.               The status is:               Active               Terminated               Contact               Hold               Pending               Inactive               The organization status is changed to Ac-               tive. This automatically creates a second               browser window with the User ID and               Passwords for that organization.               You then select Export to XLS, and these               can be printed out from XLS and faxed               to the organization.               You then close the second browser win-               dow and select ‘Save changes and Exit’               This organization is now an Active mem-               ber of the network and has full access to               the member&#39;s section.       How do I put a   Posting a   The Project manager identifies a new CTO       new clinical   New Clinical   Log on to Rapidtrials.com       trial   Trial Op-   This will take you to CTO Admin or       opportunity on   portunity on   www.rapidtrials.com/cto/asp       Rapidtrials   Rapidtrials   Click New           Creating a   Enter the CTO name           PCRS Track-   Enter the Tracking Number           ing Number   Enter if the CTO is recruiting Yes/No               (When a CTO is no longer recruiting this               must be changed to No)               Enter if the CTO is to be shown on the               web Yes/No (When the CTO is no longer               to be viewed on the web must be changed               to NO)               Enter Project Manager Name               Enter which of the following are appli-               cable (to be update, as information be-               comes available over time)               Sponsor               Sponsor contact Name               Sponsor Contract Name               CRO               CRO contact name               CRO contract name               Then select save       How do I   Creating a   Click CTO description       create a CTO   Synopsis for   This is where you create the synopsis for       Online   a Clinical   the clinical trial           Trial (CTO)   For those choices that appear in blue, click               on the blue link, type in the text that is to               appear under that link, click save and click               return               Select Therapeutic Area and indication               from the dropdown               Date CTO sent to sites               CTO Phase               Study design               Status- Proposed or awarded               Study Objective               Investigator specialty, up to three from               dropdown               Clinical Experience, do they have to have               experience or can they be trial naive               Is a certain number of past clinical trials               necessary,               indicate this here               IRB Utilization- Central or Local               Type of site, check all that apply               Is it Inpatient/Outpatient?               Key Inclusion Criteria               Key exclusion Criteria               Removal of patients from therapy               Length in enrollment in months               Note: This generates the correct amount of               30 day increments for the benchmarking               Expected enrollment               Duration of therapy               Number of patient visits               Investigator Meeting               Anticipated Start Date               Special request/equipment               Budget               There are then 5 extra criteria, which you               can label and then enter text for               Click Save       How do I   Creating an   Click SQQ design       create   SQQ   If there is another SQQ already created       a Site   Using the   that you know is identical to the one you       Qualification   same tem-   wish to create, or very similar so that you       Questionnaire   plate as a   would change just one or two things-       (SQQ) Online   previously   Click Load SQQ pattern from another           developed   CTO           SQQ Creat-   Select CTO Name and click OK           ing Custom   Say OK           Questions   This will create the same SQQ for your               clinical trial               OR               To create a brand new SQQ               Click SQQ design               There will be a list of standard questions,               these are questions that if they are com-               pleted on the profiles will pre fill for the               Investigators               Select those you wish to delete               Note: The one that is blank is actually               Board Certification               If you wish to create specialized questions,               in addition to the standard questions, click               Further Criteria               Click Simple Questions               A Question Interface appears               Let&#39;s use some examples:               How far away is the nearest airport?                 ————— in miles               Which of the following apply to your site?               Small, Medium or Large               Check all that your site has ECG, Sleep               Lab, Study Coord               What date is your next IRB meeting?               Using the Interface Label-               1. Question One               Label = How far away is your site               After Label = miles               Question Type = Text box               Question Data Type = Text               Multiple Choices =               2. Question Two               Label = Which of the following               apply to your site?               After Label =               Question Type = Combo Box (only one               answer allowed)               Question Data Type = Numeric               Multiple Choices = Small, Medium,               Large               3. Question Three               Label = Check all that your site has               After Label =               Question Type = Multiple Choices (allows               for more than one answer)               Question Data Type = Numeric Multiple               Choices = ECG, Sleep               Lab, Study Coord               4. Question Four               Label = What date is your next IRB               meeting               After Label =               Question Type = Text box               Question Data Type = Date               Multiple Choices =               Then Click Save               This saves your question and it shows up               under the Criteria Label               Continue clicking Simple Questions and               then creating questions until you are done               To change any question you have already               created, click the blue link and make your               changes and click save               When you are done Click SQQ combin-               ation, this merges the standard questions               and the special questions               Click re number, and then number the               questions so that they appear in the correct               order.               To delete a question click the delete box               then save               To make further changes to the special               questions click Edit further criteria and               click on the blue links and make the               change, click save and then SQQ               combination               When you are satisfied with the order               click Save               Then click Save Changes and               Exit       TO send       The project manager will provide with the       automatic       new CTO a list of specialties who need       emails to the       to be informed about this trial       orgs to inform       From CTO admin, click search, this       them of a new       appears above the matched site window       CTO       This will take you to the search page               Select enable- Membership Status               The choices are member, non-member, or               all               Select member               Under Investigator specialty, click enable               and choose the specialty from the drop               down box               Note; The search by specialty is an AND               search, not an OR search. So choose only               one specialty at a time.               Click Find Physicians               At the bottom of the search results page,               click select all               Review the list and those that you do not               wish to inform of the clinical trial unselect               them by clicking on the checkmark on the               left-hand side so that the box is empty.               Then click merge CTO               Select the CTO name               Click Merge               This will dump the sites you selected into               the matched window on the CTO admin               page               Repeat with each specialty until completed               From CTO admin               Click Select All next to matched window               Click Send SQQ and description               This will create an email and fax list of all               the matched organizations               To send the email click send mail all               One email is sent to each organization               contact person that you identified, the               email lists all the suitable investigators               at that site.       TO add a       Go to CTO admin       doctor that has       Under CTO name drop down list, select       submitted for a       the name and click Edit       clinical trial       OR               Enter tracking number on the top bar and               click EDIT               IF               Doctor appears in matched window               Doctor does not appear in matched               window               1. Select his name by clicking on it               Click SSS               Then click EDIT under Update               Compete the first page:               Date of submission deadline               Date of submission               Date notified of submission               Note: This last field sends an automatic               email to the site when it is completed. See               attached email               Click Save changes and Exit               His status will now be Submitted pending               selection               2. From CTO admin halfway down               Select Org Name               Select Site               Select Physician               Click ADD               He will go into the top of the matched               window               Follow above steps       To get a list of       Go to responded window       doctors       Click on first name in the box       submitted for a       Click Shift       study (not       Click on last name in the box       including those       Click Show Info       whose status is       Print report       not submitted)       To remove a       Click on his name       doctor from a       Click remove       trial               To view info for a doctor               Click his name               Click view info               Info is shown as: Name, Site, Org.               Specialty, Tel #, Fax #, Status, Last               Change       To update SSS       Click his name               Click SSS               Click Edit under Update               To view SQQ               Click his name               Click SQQ       To add a new       Click New next to Sponsor       Sponsor       Enter Info               Click Save               Click Return               Same for Sponsor Contact, Sponsor               Contract, CRO, CRO Contact, and CRO               Contract           Search Page   Every criteria you enable limits your               search               It is a wild card to search:               To search for Bill Jones, enable physician               name and enter               Bill               Jones               Bi               Ll               Jo               Nes               Etc               Click find physicians to get results               Results are shown as Org, Site, Physician,               Phone, Fax, Specialty, Status (member/               non-member), CTO, ORO               The results can be sorted by any of the               column headings, simply click on them               Clicking on the physician&#39;s name takes               you to his profile               Clicking on the site name takes you to the               site profile               Clicking on the org name takes you to the               organization profile           To transfer   If a doctor moves from one organization,           a doctor   or more likely someone entered him in the               wrong organization profile               Search for the physicians               From the results page select doctor to be               transferred               Member Admin Page               Organization Level               To create a new org, click new               To edit an existing org, select name from               drop down list and click edit               Click Transfer               Select Org and Site he is to be transferred               to               Click Transfer               To view (in read only mode) an existing               org, select name from drop down list and               click show               To view the sites for that org, select site               name from drop down and click site               Site Level               To create a new site, click new               To edit an existing site, select name from               drop down list and click edit               To view (in read only mode) an existing               site, select name from dropdown list and               click show               To view the members for that site, select               site name from drop down and click               members               To view the SSS for a site (all the trials               that they are linked with) click SSS               To delete a site, select the site name from               the drop down and click delete               Members Level               To create a new member, click new               To edit an existing member, select name               from drop down lists and click edit               To view (in read only mode) an existing               member, select name from dropdown list               and click show               To view the SSS for member (all the trials               that they are linked with) click SSS               To delete a member, select the member               name from the drop down and click delete               Please Note               If you change the organization name at               the organization level, the site level and               the member level DOES NOT AUTO-               MATICALLY CHANGE.               You must click Site and Member again to               ensure the information you are looking               at is relevant to the site that you are               viewing               To view the SSS for and org (all the trials               that they are linked with) click SSS               To delete an org, select the org name from               the drop down and click delete       SSS Search       Mini search for CTO Issues       Criteria       Results are always shown as CTO Num-               ber, Org Name, Site Name, Physician,               Specialty, Phone, Fax, Sponsor/CRO,               Status, Last Change, Access to SSS               You can search by               Tracking Number               Organization Name               Site Name               Physician Name               The more information you enter the more               limited your search               After you enter the search criteria, click               find               To get to CTO admin, click CTO               To reset search criteria, click reset           Passwords   Click Passwords Link               Select the organization that you want to               get passwords for               Click Update               Make changes and to save click update               To print, click print               To export to XLS, click export to XLS           Tracking of   These are tracked by           Web Site   SSS changes           Changes   SQQ changes               Profile changes               It tracks- Tracking number, Physician,               Site, Org, Date and Time of change, Lo-               cation of change (form name and page)           Physician   View which CTO have been sent to a           History   physician and whether they responded (yes               or no)               Search by name, site, organization or               institution (for ORO doctors)               Limit as much as you want, more info,               more limited search, another wild card               search               Hit Find               Then select which physician and click               View               History               History shown as CTOs offered responded               Yes/No               OROs offered responded Yes/No           Sponsor           Requests           Results of           tell us about           your needs           Marketer           Requests           Results of           See what we           can do for           you                  
 
         [0057]    Various other enhancements can be made to the present invention. They will now be set forth.  
                                   Functionality   Description                   Best Practices   Extension of the benchmarking capability, this would be accessible to       Across All Sites   members. Based on benchmarking metrics, those sites with the best       Benchmarked   practices will be identified by the service, contacted and interviewed on           how they obtained the results in this trial. This information will be shared           confidentially with other sites in the same protocol. This will promote           information exchange amongst sites, help research naive sites, or poorer           performing sites to achieve better results on studies, and identify problems           before a study closeout situation occurs       Secure Bulletin   Each clinical trial listed on Rapidtrials and whose status is on-going will       Board   have a one (1) way (from the service outboard) Bulletin Board where           sponsors can post information about a study including Q&amp;A type           information In addition, Sponsor project managers can use the bulletin           Board to share information about the study on a on-going basis       Rapid Budget   Separate Web Module accessible from the current website (rapidtrials.com).           Members pay a yearly fee, billed monthly. They can apply for membership           via the website (rapidtrials.com), with payment accepted via credit card. A           new user will be required to complete an activation form; this will collect           basic data on the physician and his organization. The module will ask them           questions about the type of study they wish to budget for and which           procedures are involved. Users receive a high, average, low, and your site           (which allows them to view what they charged for the procedure the last           time they used the system). The system then asks them to choose a price for           each procedure, this feeds into a basic per patient clinical trial specific study           budget template which when they have completed choosing their ranges           they can print the complete budget worksheet from the website. This           information then updates the underlying sequel table, so it will be available           to be used in the calculation for the next user.       RapidTraining   Current Training Program owned by the service is for Novice Sites and or           as a refresher course for experienced sites. Currently we have the program           on CD and will Migrate the CD based training program to the Web as a           standalone serviced       Rapid Meeting   Investigator CD platform currently exists. Will be migrated to the Web.       Rapidpatient   This will be a guide Clinical Research sites in selecting strategies and       Recruitment   tactics to aid in the clinical trial patient recruitment and retention activities.           Based upon a users description of the patient recruitment and retention           objectives they are attempting to support, the Rapidtrials web module will           suggest appropriate tactics to support the objectives. This module will also           include IRB/FDA regulations governing patient recruitment advertising and           recruitment guidelines. This module of the Rapidtrials website will be a           portal for ordering mugs, t-shirts, ads, media buying, plaques and other           promotional items through the service to enhance patient recruitment and           retention in clinical trials. A catalog of items, which are IRB/FDA           compliant that they can order through us.       Rapid Assessment   A Rapidtrials web module that uses a psycho-behavioral assessment           (similar to Myers Briggs) that has been validated by the service using           historical performance and behavioral assessment response correlation&#39;s to           identify sites with a high probability of succeeding in clinical trials.           Investigators and coordinators will complete this behavioral assessment on-           line as a predictive tool for the practice of future success in clinical trials.           Gaps in attributes will be identified for Sites as a means of guiding them in           clinical research program recruitment. For sponsors involved in site           selection, or preparing to invest in site development it will give them           another performance indicator prior to selecting sites to participate in a           clinical trial.       Industry   Generated by data entered into members organization, site and Investigator       Benchmarking   profiles, these benchmarks will be displayed by Type of Organization (I.e.           solo practice, SMO etc): Total number of protocols per year, Total grant           value per protocol, total number of patients enrolled in a clinical trial/year,           total number of Study coordinators, total number of sites doing research,           Total number of Patients per study coordinator FTE&#39;s, Average number of           Patients per year, Number of Physicians, Number of PI&#39;s, Overhead as a           percentage of total per patient budget, Study Coordinator costs as a           percentage of Total per patient budget, Investigator Fees as a percentage of           total per patient budget, Procedure, lab fees as a percentage of total per           patient budget, total number of sponsors worked for/year, Total number of           CROs/year, Actual Enrollment/Enrollment           Goal.       Site Capabilities   Data capture approved by field based consultants to gather information on       Assessment Data   sites developing research programs or preparing to participate in clinical       Capture and   trial. Migration of proprietary data capture tools to the web.       Reporting       Site Operations   Data capture pages used by field based consultants to gather information on       Specialists Site   sites developing research programs or preparing to participate in clinical       Specialists Site   sites developing research programs or preparing to participate in clinical       Development   trial. Migration of proprietary data capture tools to the web. This is the       eWorkbook   same as the above.       Site Operations   Data Capture Pages, tools and presentations to use in preparing for and       Specialists Site   monitoring site performance on a clinical trial. Migration of Proprietary       Management   Data Capture tools to the web       eWorkbook                  
 
         [0058]    While a preferred embodiment of the present invention has been set forth in detail, those skilled in the art who have reviewed the present disclosure will readily appreciate that other embodiments can be realized within the scope of the present invention. For example, the utility of the invention is not limited to the medical field. Also, any benchmarks can be calculated, in which case the forms for collecting the data are modified accordingly. Further, the benchmarks can be displayed as text, as any suitable chart, or as a combination of the two. In addition, either the Web server or the database server can incorporate the ability to handle payments from one participant to another, as well as from participants to the company operating the servers. Moreover, any mention of a specific software package (e.g., Microsoft Excel) should be construed as illustrative rather than limiting. Therefore, the present invention should be construed as limited only by the appended claims.