Discuss SCDM CCDM Exam Topic 3 Question 14

Which protocol section most concisely conveys timing of data collection throughout a study?

AStudy endpoints section

BStudy schedule of events

CProtocol synopsis

DICH essential documents

Suggested Answer: B

The Study Schedule of Events (SoE) section in the protocol is the most concise and comprehensive representation of the timing of data collection throughout a study.

According to the Good Clinical Data Management Practices (GCDMP, Chapter: Data Management Planning and Study Start-up) and ICH E6 (R2) GCP, the SoE outlines what assessments, procedures, and data collections occur at each study visit (e.g., screening, baseline, treatment visits, follow-up). This table is a foundational tool for CRF design, database structure, and edit-check development, ensuring alignment between the protocol and data management systems.

While the study endpoints section (A) defines what is measured, and the protocol synopsis (C) summarizes the design, only the schedule of events (B) specifies when data collection occurs for each parameter. The ICH essential documents (D) pertain to regulatory documentation, not study visit timing.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Management Planning and Study Start-up, Section 4.1 -- Using the Schedule of Events for Database Design

ICH E6 (R2) GCP, Section 6.3 -- Trial Design and Schedule of Assessments

FDA Guidance for Industry: Protocol Design and Data Collection Standards

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24 comments · newest first

Remedios 2 days ago

D doesn't focus on timing at all.

Carline 7 days ago

C is too vague for timing details.

Paris 12 days ago

I feel A could work too, but B is clearer.

Rhea 17 days ago

Agreed, B is the best choice.

Alex 23 days ago

I think it's B. Study schedule of events.

Hollis 28 days ago

True, B is concise and to the point.

Elfrieda 1 month ago

But C is too broad. B is more specific about timing.

Sage 1 month ago

I prefer C) Protocol synopsis. It gives a good overview.

Gearldine 1 month ago

A) Study endpoints could work, but it’s not as clear.

Kattie 2 months ago

Agreed! B is the best choice for timing details.

Renato 2 months ago

I think it's B) Study schedule of events. It clearly outlines timing.

Kandis 2 months ago

Not sure about that... I feel like C) Protocol synopsis might be better.

Gabriele 2 months ago

I agree with B! It lays it all out nicely.

Reynalda 2 months ago

Wait, I thought D) ICH essential documents covered this too?

Suzi 2 months ago

I think A) Study endpoints section is more relevant.

Dierdre 3 months ago

Definitely B) Study schedule of events. It's super clear!

Karma 3 months ago

I feel like the protocol synopsis could also touch on timing, but it seems broader than just data collection.

Ressie 3 months ago

I practiced a similar question, and I believe the study schedule of events is the most concise for timing details.

Tonette 3 months ago

I'm not entirely sure, but I remember something about the study endpoints section being important for timing too.

Melvin 3 months ago

I think the study schedule of events might be the right answer since it outlines when data is collected.

Shawnda 4 months ago

I’m confused about the protocol synopsis; does it really focus on timing, or is it more about the overall study design?

Daryl 5 months ago

I feel like I've seen a similar question before, and the study schedule of events was the answer there as well.

Walton 5 months ago

I'm not entirely sure, but I remember something about the study endpoints section being important for timing too.

Lashanda 5 months ago

I think the study schedule of events might be the right answer since it outlines when data collection happens.

SCDM CCDM Exam - Topic 3 Question 14 Discussion