IRB Approved Protocol [Regulatives / Guidelines]

posted by Jaime_R – Barcelona, 2007-03-22 15:35 (7040 d 19:55 ago) – Posting: # 595
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Dear Virendra!

❝ Can anybody give me the reference or guidance on below mentioned issue:


Just my personal opinion.

❝ Our QA division is received the original IRB approved protocol from IRB

❝ member secretary and affix the QA original copy stamp on each page of the

❝ original IRB approved protocol.


Why, to keep the QA personnel busy?
The entire protocol must have been already reviewed and released by the QA before submission to the IRB.
It's an uncommon procedure that the IRB sends the protocol back (normally they keep it).
Anyhow, the receipt should be documented and only this (the receipt) should be checked by the QA.
I don't see the point, why they stamp every page.

❝ I have objection that nobody allow to tamper the original IRB approved

❝ protocol.


Full ACK!

Regards, Jaime

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