A Data Manager is establishing a timeline for database lock for a 100-person study where...

For a well-maintained 100-subject study withongoing data cleaningandcompleted reconciliations, thedatabase lockprocess typically takesa few daysafter theLast Patient Last Visit (LPLV).

According to theGCDMP (Chapter: Database Lock and Archiving), the duration of the lock process depends on the level of data cleanliness at LPLV. If the study team has conducted continuous data cleaning, query resolution, and external data reconciliation throughout the trial, then the final lock steps (e.g., final data review, documentation, and approvals) can be completed in2–5 days.

However, if significant cleaning or reconciliation remains outstanding, lock may take several weeks. Since the question states that data are “maintained almost all clean,”Option B – a few days– is the appropriate estimate.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Lock and Archiving, Section 6.2 – Database Lock Preparation and Timelines

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Data Quality and Lock Procedures

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations – Data Lock and Archiving Procedures