A Data Manager is establishing a timeline for database lock for a 100-person study where the data have been maintained almost all clean throughout the study. All data from external labs have been received and reconciled. Which is the best estimate of the amount of time needed to lock the database after Last Patient Last Visit?
Correct Answer: B
For a well-maintained 100-subject study with ongoing data cleaning and completed reconciliations, the database lock process typically takes a few days after the Last Patient Last Visit (LPLV).
According to the GCDMP (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 in 2-5 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