Bioequivalence and Bioavailability Forum • IEC/IRB approval

sidhu.m99
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2008-02-05 12:01
(6720 d 19:46 ago)

Posting: # 1583
Views: 3,303

IEC/IRB approval [Regulatives / Guidelines]

Dear All,

Hi,

I just wanted to know that 'Is there any timeline for the IEC/IRB approval procedure'?

Since I have gone through some of the protocols having approval date, the very next date of submission of the documents to IEC/IRB.

In one of the seminars which I have attended, it was told that minimum 1 week time (For BA/BE Studies)should be there between submission and approval of Protocols, ICFs, CRFs and other supplement documents; since all the members should have time to read the documents atleast once.

My query is that, is there any regulatory guideline which defines the timelines for Ethics committee approval procedure.

hsan
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2008-02-05 12:36
(6720 d 19:10 ago)

@ sidhu.m99
Posting: # 1585
Views: 2,655

IEC/IRB approval

Post reply

Though there is no specific timeframe mentioned on the subject. A reasonable time should be there for thorough evaluation of the protocol. This depends on the design and IP and associated AE/SAEs and other work taken up by committe on that sitting. If any protocol is approved in less than 24 hours, it is doubtful.

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Edit: Full quote removed. Please see this post and the Forum's Policy as well! [Helmut]

sidhu.m99 ● 2008-02-05 13:28 (6720 d 18:19 ago) @ hsan Posting: # 1587 Views: 2,662	IEC/IRB approval Post reply
	Dear Hsan, Hi, Thanx 4 ur prompt reply. -- Edit: Full quote removed. Please see this post! [Helmut] P.S.: Your keyboard seems to be seriously damaged, you might want to replace it by a better one.

ShankarCL ● 2008-02-29 13:35 (6696 d 18:12 ago) @ sidhu.m99 Posting: # 1647 Views: 2,599	IEC/IRB approval Post reply
	Expedited approvals are very critically analyzed by the authorities. Hence it is better to go for a full approval, except in case of any minor changes or as that mentioned in the guidelines.