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SOCRA CCRP Exam - Topic 1 Question 15 Discussion

According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?
B) Investigator/institution
A) OHRP
C) Regulatory authority
D) DSMB

SOCRA CCRP Exam - Topic 1 Question 15 Discussion

Actual exam question for SOCRA's CCRP exam
Question #: 15
Topic #: 1
[All CCRP Questions]

According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?

Show Suggested Answer Hide Answer
Suggested Answer: B

ICH E6(R2) 5.6.1: ''The sponsor should ensure agreement from the investigator/institution on the financial aspects of the trial.''

This ensures transparency in compensation, reimbursement, and budget.


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Herman
5 hours ago
I think the investigator or institution has to approve the financial aspects, but I'm not entirely sure if there are other parties involved.
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Wilson
5 days ago
I’m leaning towards the investigator/institution too, but I wonder if the DSMB has any role in this area.
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Marshall
11 days ago
I feel like the regulatory authority might have some say in the financial aspects, but I can't recall the specifics.
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Tarra
16 days ago
I remember a practice question about this, and I think it was definitely the investigator/institution.
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Aja
2 months ago
I think the investigator or institution has to approve the financial aspects, but I'm not entirely sure.
upvoted 0 times
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