SCDM CCDM Exam - Topic 5 Question 6 Discussion

Actual exam question for SCDM's CCDM exam

Question #: 6
Topic #: 5

[All CCDM Questions]

In the transfer of obligations for a double-blind, multi-center trial, a sponsor has maintained the task of creating the randomization schedule. Who at the sponsor company should create the randomization schedule?

AThe sponsor's project statistical programmer

BThe CRO biostatistician

CA sponsor's biostatistician not on the project

DThe sponsor's project biostatistician

Show Suggested Answer

Suggested Answer: C

In a double-blind clinical trial, the randomization schedule must be generated by an independent biostatistician not directly involved in study operations or data management to preserve study blinding and integrity.

According to ICH E9 and the GCDMP (Chapter: Regulatory Requirements and Compliance), randomization generation and blinding must be handled in a way that prevents bias or unintentional unblinding of study personnel. The sponsor's biostatistician not assigned to the project (Option C) is the appropriate person because they have the necessary statistical expertise but remain operationally independent from study execution.

A project biostatistician (Option D) or programmer (Option A) directly involved in data analysis could inadvertently compromise blinding. The CRO biostatistician (Option B) should not perform this function if the sponsor retains randomization responsibility.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Regulatory Requirements and Compliance, Section 6.4 -- Randomization and Blinding

ICH E9 -- Statistical Principles for Clinical Trials, Section 5.4 -- Randomization Procedures and Blinding

FDA Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics, Section 4.3 -- Maintaining Blinding Integrity

by Dwight at Nov 22, 2025, 01:48 PM

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Ula

24 hours ago

B could work too, but the CRO might not align with the sponsor's goals.

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Wilbert

6 days ago

Why not A? The programmer knows the data well.

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Staci

11 days ago

I think D is the best choice.

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Lou

16 days ago

Isn't it risky to have the project biostatistician do it? What if they bias the results?

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Ashton

22 days ago

Wait, why not C) A sponsor's biostatistician not on the project? Seems odd!

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Markus

27 days ago

I disagree, it should be B) The CRO biostatistician. They bring an outside perspective.

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Nu

2 months ago

I think it should be A) The sponsor's project statistical programmer. They handle the data!

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Jerry

2 months ago

Definitely D) The sponsor's project biostatistician. They know the project best!

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An

2 months ago

The sponsor's project biostatistician? Nah, they're too busy playing golf. Gotta be the statistical programmer, hands down.

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Glory

2 months ago

Haha, the CRO biostatistician? Yeah, right, like they're gonna let the outsiders handle that. Definitely the sponsor's programmer.

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Solange

2 months ago

C'mon, a sponsor's biostatistician not on the project? That's just asking for trouble. Gotta go with the project statistical programmer.

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Jesse

2 months ago

I agree, the sponsor's project statistical programmer is the best choice. They can ensure the randomization is properly implemented.

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Alyce

3 months ago

I’m leaning towards option D, the project biostatistician, but I could see an argument for the statistical programmer too.

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Kris

3 months ago

I remember a practice question where the CRO biostatistician was involved in randomization, but I feel like the sponsor's team should have more control over it.

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Zack

3 months ago

I think the project biostatistician would be the right choice since they are directly involved with the trial, but I'm not entirely sure.

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Chi

3 months ago

This looks straightforward to me. The sponsor is responsible for the randomization schedule, so it should be created by their own biostatistician who is part of the project team. Option D seems like the clear answer here.

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Reynalda

3 months ago

I'm a bit confused by this question. There are a few different statistical roles mentioned, and I'm not sure how to differentiate their responsibilities. I'll need to review my notes on the typical responsibilities of a sponsor's project team versus a CRO's team.

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Paola

3 months ago

Okay, let me see. The sponsor is maintaining the randomization schedule, so it's likely an internal resource that should handle this. I'm leaning towards option D - the sponsor's project biostatistician seems like the most appropriate choice here.

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Katie

4 months ago

The sponsor's project statistical programmer should create the randomization schedule. They have the necessary expertise and access to the project data.

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Isaiah

4 months ago

I’m confused about whether it should be someone from the sponsor or the CRO. I need to review the roles again.

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Milly

5 months ago

Hmm, I'm a bit unsure about this one. The options seem to focus on the sponsor's statistical resources, but I'm wondering if the CRO biostatistician might also be involved in this process. I'll need to think through the roles and responsibilities more carefully.

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Sharee

5 months ago

This seems like a straightforward question about who should create the randomization schedule in a clinical trial. I think the key is to identify the appropriate statistical expertise required for this task.

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Nida

4 months ago

But what about the CRO biostatistician? They might have valuable insights too.

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Ora

4 months ago

Agreed! They have the right expertise for creating the schedule.

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Tayna

4 months ago

I believe it should be the sponsor's project biostatistician. They know the project best.

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