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SCDM CCDM Exam - Topic 4 Question 21 Discussion

A Data Manager is drafting a report for clinical operations staff for support in responding to questions about milestone-based site payments. Which is the most important information to display?
C) Expected versus actual milestones met to date, by site
A) Milestones met by month, by site
B) Milestones met by month, by type
D) Milestones included in the last payment by site, by patient

SCDM CCDM Exam - Topic 4 Question 21 Discussion

Actual exam question for SCDM's CCDM exam
Question #: 21
Topic #: 4
[All CCDM Questions]

A Data Manager is drafting a report for clinical operations staff for support in responding to questions about milestone-based site payments. Which is the most important information to display?

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Suggested Answer: C

When reporting milestone-based site payment information, the most critical information to include is expected versus actual milestones met to date, by site.

According to the Good Clinical Data Management Practices (GCDMP, Chapter: Project Management and Communication), effective reporting must support operational and financial decision-making by presenting performance indicators in a clear, actionable format. Site payments in clinical studies are typically tied to specific milestones such as subject enrollment, visit completion, or data cleaning achievements.

By comparing expected (planned) versus actual (achieved) milestones per site, the Data Manager provides clinical operations staff with an accurate view of site progress and payment eligibility. This allows for identification of delayed sites, forecasting of upcoming payments, and early intervention for underperforming centers.

While milestone summaries by month or type (options A and B) may be useful for trend analysis, they lack the operational detail required for financial tracking. Milestone data by patient (option D) is overly granular for site-level payment management.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Project Management and Communication, Section 6.2 -- Data Reporting for Site Performance and Payments

ICH E6 (R2) Good Clinical Practice, Section 5.18.4 -- Communication and Monitoring Reports

FDA Guidance for Industry: Oversight of Clinical Investigations -- Site Management and Reporting


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