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According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?
Suggested Answer: B
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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.
22 comments · newest first
TA
Tasia
2 days ago
But the investigator has direct control over trial finances. B makes sense.
AZ
Azzie
7 days ago
I’m leaning towards C) Regulatory authority. They oversee compliance.
AU
Audrie
12 days ago
Agreed! The investigator must approve the budget too.
GA
Gayla
18 days ago
I think it's B) Investigator/institution. They need to ensure funds are used properly.
ME
Merissa
23 days ago
Really? I didn't know the investigator had that much power!
AL
Alpha
28 days ago
Yep, B is correct! GCP guidelines are clear on this.
KA
Karan
1 month ago
Wait, I thought the regulatory authority had to approve everything?
LU
Lucia
1 month ago
Totally agree, B is the right answer!
TE
Teri
1 month ago
It's the Investigator/institution that needs to approve the finances.
BE
Bette
2 months ago
Not sure about that, seems like a lot of responsibility for the investigator.
MA
Malcom
2 months ago
Yup, definitely B! Makes sense for the investigator to be involved.
MI
Minna
2 months ago
Wait, I thought the regulatory authority had to approve everything?
VA
Valentine
2 months ago
Totally agree with that!
DO
Dortha
2 months ago
B) Investigator/institution is correct!
FI
Filiberto
2 months ago
I thought the DSMB was more about safety and monitoring, so I don't think they would be involved in financial approvals.
LI
Lisbeth
3 months ago
I feel like the regulatory authority might have some oversight, but I can't recall if they directly approve financial aspects.
AL
Allene
3 months ago
I remember a practice question about this, and I think it was definitely the investigator/institution that had a role in the financial approval.
HE
Herman
3 months 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.
WI
Wilson
3 months ago
I’m leaning towards the investigator/institution too, but I wonder if the DSMB has any role in this area.
MA
Marshall
3 months ago
I feel like the regulatory authority might have some say in the financial aspects, but I can't recall the specifics.
TA
Tarra
4 months ago
I remember a practice question about this, and I think it was definitely the investigator/institution.
AJ
Aja
5 months ago
I think the investigator or institution has to approve the financial aspects, but I'm not entirely sure.