When aprotocol is amended mid-study, resulting in additional data collection requirements, theData Management Plan (DMP)must beupdated accordinglyand all relevant stakeholders must benotified.
According to theGCDMP (Chapter: Data Management Planning and Study Start-up), the DMP is aliving documentthat defines all data management processes for a clinical study. It must accurately reflect thecurrent data flow, CRF design, validation procedures, and reporting structure. Any protocol amendments affecting data capture, structure, or analysis require immediate DMP revision and distribution to ensure alignment across data management, clinical, and biostatistics teams.
Failure to update and communicate DMP changes can lead to misalignment in data handling and introduce compliance risks during audits or inspections. Therefore,Option Bis correct: the DMP must be updated and the change communicated to all stakeholders (e.g., sponsor, CRO, clinical operations, biostatistics).
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Management Plan (DMP), Section 5.3 – Maintaining and Updating the DMP
ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Documentation of Protocol Changes and Data Handling Procedures
FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations – Section on Data Management Documentation
