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During an audit for a Phase II IND study, the auditor identified unreported serious protocol deviations. Which party must take prompt action to ensure compliance?
Suggested Answer: C
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The sponsor holds ultimate responsibility for trial oversight and compliance.
ICH E6(R2) 5.20.1: If noncompliance is discovered, the sponsor must ''take prompt action to secure compliance'' and, if necessary, terminate participation of the investigator/institution.
21 CFR 312.56(b): Sponsors must ensure proper conduct and report investigators who fail to comply to the FDA and IRB.
While investigators commit to protocol adherence, once deviations are identified, the sponsor must act to safeguard subjects and trial validity.
14 comments · newest first
KE
Keneth
10 months ago
Definitely the sponsor, they hold the ultimate accountability.
LA
Lashawnda
10 months ago
Wait, I thought the investigator had more responsibility in these cases?
DE
Delmy
10 months ago
Totally agree, the sponsor has to step up!
YO
Yolando
10 months ago
Really? I’m surprised it’s not the investigator’s job to report those deviations!
TA
Tanesha
10 months ago
It's the sponsor's responsibility to ensure compliance.
TA
Tammi
11 months ago
This is tricky! I want to say the sponsor, but I also remember discussions about the IRB's role in oversight.
JA
Jackie
11 months ago
I feel like the CRO might have some role in this, but I can't recall if they have the final say on compliance issues.
TH
Thea
11 months ago
I remember a similar question where the investigator was held accountable for protocol deviations. Could it be A?
MA
Marci
11 months ago
I think the sponsor is usually responsible for ensuring compliance, but I'm not entirely sure if the investigator has some obligations too.
RO
Ronny
12 months ago
This is a good test of my understanding of clinical trial oversight. I'll make sure to consider each party's obligations under the regulations.
LU
Lucina
12 months ago
I'm a bit confused by the wording of the question. Let me re-read it carefully and think through the different options.
RA
Raina
12 months ago
Okay, I think I know the answer here. The sponsor has the ultimate responsibility to ensure compliance, so I'd go with C.
KA
Kate
1 year ago
Hmm, not sure about this one. I'll need to review the roles and responsibilities of the different parties in a clinical trial.
OL
Olen
1 year ago
This seems like a straightforward compliance question. I'd focus on the key parties involved and their responsibilities.