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A protocol is updated mid-study to add an additional procedure about which data needs to be collected. Which of these statements applies?
When a protocol is amended mid-study, resulting in additional data collection requirements, the Data Management Plan (DMP) must be updated accordingly and all relevant stakeholders must be notified.
According to the GCDMP (Chapter: Data Management Planning and Study Start-up), the DMP is a living document that defines all data management processes for a clinical study. It must accurately reflect the current 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 B is 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