Clinical Data Review Plan Description of process for providing data to one or more clinicians who will complete a clinical review. {Only include if a clinical review will be conducted. If a clinical review will be conducted, this plan would also specify the fields that will be reviewed and the timing of the review. This document may be created well after the initiation of the study in the EDC.} Project data manager EDC Specifications Review Checklist Describes and tracks the process for review and approval of the study-specific EDC requirements (e.g., blank and annotated CRF, edit check plan) prior to the initiation of User Acceptance Testing. Project data manager Study Startup Checklist List of items to be completed during study startup. Project data manager Study Timeline Projected timeline of study events and deliverables Project manager Sponsor Converted Database Specifications Describes the requirements of the clinical database that is delivered back to the sponsor after database lock. {This conversion may not be required. Delete item if not applicable. Alternatively, this may be the specifications for the creation of de-identified public use data} Project SAS programmer Development and Testing Responsibility Matrix Identifies tasks and deliverables for this project and indicates who is responsible for writing, executing, reviewing, and approving each item. Project data manager
Reports {List reports anticipated to be generated for this study in Table 3; examples are shown below. Additional reports that are agreed upon during the course of the study do not require an immediate amendment to the CDMP. Simply ensure that the final version of the CDMP (usually signed immediately prior to database lock) reflects all delivered reports.} Table 3. List of Data Management Reports Report Name Description/Purpose Frequency Recipients/ Users Method for Provision Medical Coding Report Summaries of verbatim and corresponding coded AEs and ConMeds. For approval of medical coding, including split events, preferred terms, and System Organ Class. 1 month prior to DB freeze for DSMB reports and prior to database lock. Medical Officer or designee Emailed zip file Query override report for EDC Lists all queries where the data entry user overrode the query with no change, includes the explanation for the change/DM review for acceptability of overrides. Monthly Data Managers and other DM staff Automated SAS report stored on local network.
Database Closure {This section should describe all processes associated with final database closure. Subsections proposed here include final pre-closure data checks; QA review and actual database lock; and procedures for unlocking a database in the event that data must be corrected after lock.} Checks {Describe the set of closure procedures that will be performed to database lock to verify the integrity and completion of the database. In some cases these may be the same data checks described in above sections, repeated until all queries are resolved and the data are determined to be clean. Other appropriate checks at this stage may include: Check that all expected CRFs have been entered; Check that the project database is consistent with the specifications in the project data dictionary; Determine the status of each subject entered (i.e., excluded, ongoing, completed, withdrawn, lost to follow-up, etc.); Check for value formatting problems in database exports; Check for consistency between whole-date fields and associated fields; Confirm that all expected site signatures have been applied.} Assurance Audit and Database Lock {Describe QA processes to be employed during study conduct to assure data quality, such as clinical site monitoring. Specify QA procedures after study conduct to be performed to ensure all possible errors are detected and corrected before final database lock. For example, an audit may be performed of a sample of completed CRFs in the EDC system against exported SAS datasets to ensure the integrity of the final study data. Explain how approval for final database lock will be sought and documented, and how the lock will be achieved at the database level. If a separate soft lock will take place prior to final lock, describe how the two events will take place and what may distinguish soft from hard lock in terms of user access and write privileges.} Unlock {Database unlock should only occur in extraordinary circumstances. As such, special controls are needed to limit the scope of unlock. Explain here the conditions necessary to justify database unlock, the procedures for documenting justification and approval by relevant personnel (e.g., the Principal Investigator, Medical Monitor, Program Officer, etc.), personnel authorized to unlock the database, and procedures for making and documenting the approved changes.}