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After the sponsor's auditor completes the final audit report for a Phase II trial with an investigational new drug, Which option best is responsible for providing the audit certificate to the clinical site?
Suggested Answer: D
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Audits are part of sponsor quality assurance to ensure trial compliance.
ICH E6(R2) 5.19.3: ''The sponsor's auditing procedures should include the provision of an audit certificate where required.''
ICH E6(R2) 8.2.20: Audit certificates are essential documents generated and retained by the sponsor.
IRBs (A), regulators (B), and DSMBs (C) are not responsible for audit documentation. Therefore, only the sponsor issues and maintains audit certificates, providing them to sites when appropriate.
Correct answer: D.
ICH E6(R2), 5.19.3.
ICH E6(R2), 8.2.20.
26 comments · newest first
RU
Ruthann
3 months ago
No, it's the sponsor's responsibility to ensure compliance.
AY
Ayesha
3 months ago
But what about the clinical site? They should get it too, right?
SH
Sherita
3 months ago
Agreed, the sponsor has the final say.
AL
Alverta
4 months ago
I think the sponsor should provide the audit certificate.
PA
Pamela
5 months ago
Seems straightforward, but I wonder if there are exceptions.
AL
Alpha
5 months ago
Yup, the sponsor's auditor wraps it up.
VI
Virgie
5 months ago
Wait, I thought the site had to handle that?
CE
Celeste
6 months ago
Totally agree, it's on the sponsor!
FE
Felicidad
6 months ago
The sponsor is responsible for the audit certificate.
DU
Dulce
6 months ago
I bet the auditor is just waiting for the sponsor to ask for that certificate so they can charge an extra fee!
AR
Arlene
6 months ago
The sponsor better not lose that audit certificate! Clinical sites need that to prove the trial was legit.
LU
Luisa
6 months ago
Isn't the sponsor the one who hired the auditor? They should be the ones to hand over the certificate.
JA
Janine
6 months ago
The sponsor's auditor should provide the audit certificate to the clinical site. That's their job, right?
AN
Anisha
7 months ago
The sponsor is responsible for providing the audit certificate to the clinical site.
YO
Yolande
7 months ago
I thought the clinical site had to request the audit certificate, but that doesn't seem right now that I think about it.
DA
Dana
7 months ago
I feel like the auditor might give the certificate to the sponsor, who then sends it to the site. It’s a bit confusing.
ZA
Zana
8 months ago
I remember a practice question where the site was involved in the audit process, but I can't recall if they provide the certificate.
DO
Doug
8 months ago
I think the sponsor is responsible for providing the audit certificate, but I'm not entirely sure.
WE
Weldon
8 months ago
Yeah, I agree. This is about understanding the typical flow of information and documentation in a clinical trial. The sponsor should be the one to provide the audit certificate to the site.
CO
Corrie
8 months ago
I think the key here is understanding the relationship between the sponsor, auditor, and clinical site. The sponsor is likely the one who needs to officially share the audit results with the site.
LO
Lorrie
8 months ago
I'm a bit confused on this one. Is the sponsor always responsible for providing the audit certificate, or does it depend on the specific trial details?
NA
Nakita
9 months ago
Okay, let's see. The auditor completed the final report, so I'm guessing the sponsor is responsible for providing the audit certificate to the site.
AS
Ashleigh
9 months ago
Hmm, this seems like a tricky one. I'll need to think through the different roles and responsibilities carefully.
DA
Dana
2 months ago
The auditor usually submits it to the sponsor first, right?
AN
Annita
3 months ago
But what about the auditor's role?
TH
Thomasena
3 months ago
I think the sponsor should provide the audit certificate.