ICH E6(R3) - Good Clinical Practice 4.2-later: Correct errors in an attributed, justified, source-supported and timely way; transfer and migrate data through validated or reconciled processes; finalise data sets for analysis under documented procedures; archive data and metadata retrievably and protected; and destroy them only when no longer required

What does 4.2-later require?

Processes should correct errors that could affect reliability, with each correction attributed to the person or system making it, justified, supported by source records from around the original entry and done promptly. Validated or otherwise appropriate processes such as reconciliation should keep data and metadata intact and confidential when transferred, exchanged or migrated between systems, with the process documented for traceability and reconciliation used to avoid loss or unintended change. The quality of data needed for interim and final analyses should be defined and achieved through timely capture, verification, validation, review and correction of errors and, where possible, omissions that matter for safety or reliability; finalisation activities (reconciliation, error correction, medical coding, addressing noncompliance including deviations) should be confirmed and documented under pre-specified procedures; and extraction and analysis set determination should follow the planned analysis and be documented. Data and metadata should be archived retrievably and readably, protected from unauthorised access and alteration for the retention period, and may be permanently destroyed only when no longer required by regulation.