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SOCRA CCRP Exam - Topic 1 Question 6 Discussion

Actual exam question for SOCRA's CCRP exam
Question #: 6
Topic #: 1
[All CCRP Questions]

The sponsor of a multi-institutional clinical trial provided a site with information regarding a newly identified unanticipated adverse event attributed to study drug administration. The site's investigator has a subject actively receiving this study drug. Which of the following is the site investigator's responsibility to the subject?

Show Suggested Answer Hide Answer
Suggested Answer: C

Investigators are obligated to inform subjects of new information that may affect their willingness to continue.

ICH E6(R2) 4.8.2: ''If new information becomes available that may be relevant to a subject's willingness to continue participation, the informed consent document should be revised, and the subject should be informed in a timely manner.''

21 CFR 50.25(b)(5): Consent must include a statement that ''significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided.''

Thus, the investigator must communicate new risk information to the subject.

Discontinuation (A) may not be warranted unless medically indicated. Reporting to FDA (B) is the sponsor's role. Sharing subject contact with sponsor (D) would violate confidentiality.

Correct answer: C.


ICH E6(R2), 4.8.2.

21 CFR 50.25(b)(5).

by Cassi at Nov 20, 2025, 02:38 AM

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Benton
9 hours ago
Agree with C, but isn't there a legal risk if they don't act fast?
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Mertie
6 days ago
I thought they had to stop the drug immediately.
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Lavera
11 days ago
Wait, can they really just keep giving the drug after an adverse event?
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Rima
16 days ago
The investigator must inform the subject about new findings.
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Aleisha
21 days ago
C is the clear winner here. Can't leave the subject in the dark about this.
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Rima
26 days ago
I agree, C is the right choice. Transparency with the subject is crucial.
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Nydia
1 month ago
Definitely C. The subject deserves to know about the potential risks.
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Hortencia
1 month ago
Giving the subject's contact info to the sponsor seems a bit off to me; I don’t think that’s the right approach. I’d focus more on the subject's safety first.
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Rosann
1 month ago
I feel like submitting the safety update to the regulatory authority is important too, but I’m not sure if that’s the investigator's immediate responsibility in this case.
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Solange
2 months ago
I remember a practice question where we discussed the importance of patient safety, but I’m not sure if that means they have to stop the drug right away.
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Salley
2 months ago
I feel pretty good about this question. Based on my understanding of investigator responsibilities, I think the best answer is to provide the subject with the new safety information, which is option C. The other choices don't fully address the investigator's duty to the participant.
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Tomoko
2 months ago
This is a tricky one. I can see the logic behind a few of the answers, but I'm not sure which one is the most complete or appropriate response. I'll have to review the relevant guidelines and regulations to make sure I get this right.
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Gregg
2 months ago
Okay, I've got this. The investigator's top priority has to be informing the subject about the new safety information, so I'm going with option C. Discontinuing the drug is important too, but keeping the subject in the loop is crucial.
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Cristina
2 months ago
C is the correct answer. The site investigator has a responsibility to inform the subject of the new safety findings.
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Dalene
2 months ago
I think the investigator should definitely inform the subject about the new findings, so I’m leaning towards option C.
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Antonio
3 months ago
This question is tricky! I think the investigator should inform the subject.
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Izetta
3 months ago
Definitely C! Keeping subjects informed is crucial.
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Daisy
3 months ago
Hmm, I'm a bit unsure about this one. There are a few options that seem reasonable, but I'm not totally confident in my ability to pick the best one. I'll have to think it through carefully.
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Haydee
3 months ago
This seems like a straightforward question about an investigator's responsibilities when a new safety issue arises. I think the key is to identify the most important action the investigator must take to protect the subject.
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