SCDM CCDM Exam - Topic 2 Question 13 Discussion

Actual exam question for SCDM's CCDM exam

Question #: 13
Topic #: 2

[All CCDM Questions]

A protocol is updated mid-study to add an additional procedure about which data needs to be collected. Which of these statements applies?

AThe DMP should be updated to reflect the changes to the protocol, but this update does not need to be communicated

BThe DMP should be updated to reflect the changes to the protocol and stakeholders notified

CThe DMP does not need to be updated as it represents the data at the beginning of the trial only

DThe DMP does not need to be updated until the end of the trial and all updates are included in the DMP to indicate what happened in the trial

Show Suggested Answer

Suggested Answer: B

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

by Derick at Apr 11, 2026, 02:43 PM

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Myra

3 days ago

I think the DMP definitely needs to be updated, but I'm not sure if stakeholders need to be notified right away.

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