Once a clinical database islocked, it becomesread-only— no further data modifications can be made by any users, including site personnel. This ensures that the data arefinalized, consistent, and auditablefor statistical analysis and regulatory submission.

According to theGCDMP (Chapter: Database Lock and Archiving), the lock process involves freezing the database to prevent accidental or unauthorized changes. After lock, access permissions are restricted, and all edit and update functions are disabled. If any corrections are required post-lock, the database must beunlocked under controlled procedures(with full audit trail documentation).

Thus,option C—The site study coordinator is not able to make the change— correctly reflects standard EDC functionality and regulatory compliance.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Database Lock and Archiving, Section 5.2 – Database Lock Procedures and Controls

ICH E6(R2) GCP, Section 5.5.3 – Data Integrity and Audit Trail Requirements

FDA 21 CFR Part 11 – Controls for Electronic Records and System Lock Functions