SOCRA CCRP Exam - Topic 3 Question 8 Discussion

Actual exam question for SOCRA's CCRP exam

Question #: 8
Topic #: 3

A clinical investigator terminated a Phase IV drug study. In accordance with the ICH GCP Guidelines, which of the following documents should the clinical investigator maintain?

AThe master randomization list

BThe completed subject identification code list

CThe final trial closeout monitoring report

DThe audit certificate

Show Suggested Answer

Suggested Answer: B

Upon study closure, investigators must maintain documentation that allows subject data to be linked back if necessary. The Subject Identification Code List is a key essential document for ensuring traceability while maintaining confidentiality.

ICH E6(R2) 8.3.21: ''Subject Identification Code List --- A list of all subjects randomized to trial numbers, allowing investigator to identify each subject in case follow-up is required. This list should be kept in a confidential manner and retained for the maximum retention period.''

ICH E6(R2) 8.4: Essential documents for investigators include items needed for subject identification, protocol compliance, and trial closure.

Other listed documents (randomization list, monitoring report, audit certificate) are maintained by the sponsor, not the investigator. The subject code list ensures that in the event of a safety issue, regulatory authority queries, or subject withdrawal, the investigator can trace back records.

Thus, the correct answer is B (Completed Subject Identification Code List).

ICH E6(R2), 8.3.21 (Essential documents: Subject identification code list).

ICH E6(R2), 8.4 (Essential documents for trial closure).

by Ailene at Nov 19, 2025, 05:39 PM

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Ressie

2 months ago

I feel like C is the best option. It wraps up the study properly.

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Alline

2 months ago

D seems less relevant since it's about audits, not study closure.

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Lashaunda

2 months ago

B makes sense too. We need to track subjects.

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Shaun

2 months ago

I agree, but A is also important for randomization.

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Mozell

2 months ago

I think it's C. The final trial closeout report is crucial.

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Chery

2 months ago

Surprised they can just terminate a Phase IV study like that!

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Simona

3 months ago

I thought the master randomization list was crucial for all phases?

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Bambi

3 months ago

Wait, are we sure about the audit certificate? Seems less relevant.

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Chauncey

3 months ago

Definitely the completed subject identification code list too!

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Alva

4 months ago

Haha, the audit certificate? What is this, a game of "Spot the Odd One Out"?

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Ricarda

4 months ago

The final trial closeout monitoring report sounds like the right choice to me. Gotta dot those i's and cross those t's.

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Xuan

4 months ago

I'd go with the completed subject identification code list. Keeping track of those participants is crucial.

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Willard

4 months ago

The master randomization list seems crucial for transparency, but I can't recall if it’s specifically required to be maintained in this scenario.

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Micah

4 months ago

I’m a bit confused about the audit certificate. I feel like it’s important, but I’m not sure if it’s necessary to keep it after terminating a study.

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Ruth

4 months ago

I remember a practice question about maintaining documentation after a study ends, and I think the completed subject identification code list was mentioned as important.

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Fairy

5 months ago

I think the investigator should definitely keep the final trial closeout monitoring report, but I'm not entirely sure if that's the only document required.

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Tanesha

5 months ago

I'm feeling confident about this. The clinical investigator should maintain the completed subject identification code list in accordance with the ICH GCP Guidelines after terminating the Phase IV drug study.

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Hillary

5 months ago

Okay, let me think this through. The question is asking about the documents the investigator should maintain, so I'll need to focus on the ICH GCP requirements for study closeout. I'm pretty sure the subject identification code list is one of them.

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Gertude

5 months ago

The master randomization list is definitely the way to go. Gotta keep those codes under lock and key!

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Detra

5 months ago

Gotta keep the final trial closeout monitoring report, right?

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Marcelle

6 months ago

C is definitely the right choice. It summarizes everything.

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Stephane

6 months ago

The audit certificate? Really? That's like the least important thing on this list. Come on, people!

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Lemuel

6 months ago

Hmm, I'm a bit confused on this one. I'll need to review the ICH GCP Guidelines more closely to determine which document the investigator should maintain after terminating the Phase IV study.

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Alline

6 months ago

I think I know the answer to this one. The ICH GCP Guidelines require the clinical investigator to maintain the completed subject identification code list.

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