In anElectronic Data Capture (EDC)system, even after a data manager completes all manual queries and marks data as "clean," the data may later appearuncleanifthe site (study coordinator)makes subsequent updates in the system after re-reviewing thesource documents.
According to theGood Clinical Data Management Practices (GCDMP, Chapter: Electronic Data Capture Systems), site users maintain the authority to modify data entries as long as the system remains open for data entry. TheEDC system audit trailcaptures such changes, which can automatically invalidate prior data reviews, triggering new discrepancies or changing system edit-check statuses.
This situation commonly occurs when the site identifies corrections in the source (e.g., wrong date or lab result) and updates the EDC form accordingly. These post-cleaning changes require additional review cycles to ensure the database reflects accurate and verified information before final lock.
Options B, C, and D are incorrect — CRAs and medical monitors cannot directly change EDC data; they can only raise queries or request updates.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Electronic Data Capture Systems, Section 6.3 – Post-Cleaning Data Changes and Audit Trails
ICH E6 (R2) GCP, Section 5.5.3 – Data Integrity and Change Control
FDA 21 CFR Part 11 – Electronic Records: Change Documentation Requirements
