A protocol amendment adds three data elements to the vital signs screen and two additional...

Thebest practicewhen implementing aprotocol amendmentthat affects CRF content or data collection timing is toupdate the eCRF completion guidelines and notify sites before implementing the change.

According to theGCDMP (Chapter: CRF Design and Data Collection), theeCRF Completion Guidelines (eCRF CG)are an essential study tool that instructs site personnel on accurate and consistent data entry. When new data elements or collection time points are added, the guidelines must berevised, version-controlled, and communicatedto all users prior to implementation to ensure sites collect and enter data correctly.

Simply relying on the revised CRF (option C) or updating the document without notification (option B) violates communication and training standards. Likewise, notifying sites without updating the documentation (option D) leaves insufficient reference material for data entry compliance.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 5.5 – Managing CRF Revisions and Site Communication

ICH E6 (R2) GCP, Section 5.18.4 – Communication of Protocol Amendments and Documentation Updates

FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, Section 4.3 – Site Communication and Documentation Management