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in the project data dictionary; Determine the status of each subject entered (i.e., excluded, ongoing, completed, withdrawn, lost to follow-up, etc.); Check for value formatting problems in database exports; Check for consistency between whole-date fields and associated fields;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.}
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.}
clinical-data-management-plan-template_0.docx