Which records changes, additions, or corrections made to the Case Report Form after initial data were recorded?

• A. Investigational Products Accountability at the Site
• B. Documentations of CRF Corrections
• C. Subject Enrollment Log
• D. Notification by Sponsor to Investigators of Safety Information

Answer: (B)

The key idea is documenting CRF changes to preserve traceability. When data are recorded on a Case Report Form and later edited, added, or corrected, those edits must be captured as CRF corrections with an audit trail that shows what was changed, when, by whom, and why. This preserves data integrity and regulatory compliance by making every modification transparent and verifiable against source documents. The other options relate to separate study processes—IP inventory at the site, the subject enrollment log, and sponsor safety communications—and do not capture edits to CRF data after initial recording.