Protocol amendment
(10/08/2003)

Question 1:

I have a question regarding amendments made to protocols under INDs in which our physicians serve as the sponsor and PI. Is it acceptable to initiate the amended protocol once we have submitted the amendment to the FDA as well as have written IRB approval? Or is there a 30-day waiting period (from date of receipt at FDA) like there is with a new IND? (In reading 21 CFR 312.30 and 312.40, it still is not completely clear to me.)

Answer 1:

21 CFR 312.20(b) states, "A sponsor shall not begin a clinical investigation subject to §312.2(a) until the investigation is subject to an IND which is in effect in accordance with §312.40." 21 CFR 312.40(b) states, in part,

"An IND goes into effect: (1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under §312.42..."

In other words, a study may not begin until an IND is in effect. The thirty day waiting period applies to submission of the IND, not to additional protocols submitted to the IND, or amendments to previously submitted protocols. Other protocols submitted to an IND that is in effect may begin at once, provided, of course, that there are no clinical hold issues.

One other thing: Each protocol involving an exception from informed consent for emergency research under 21 CFR 50.24 is required to have a separate IND (and, thus, must serve the 30 day waiting period). These studies cannot begin without the prior written authorization from FDA. [See 21 CFR 312.20(c).]

Just wanted to add one more thing. It may also be helpful to communicate with FDA's reviewing division about a newly submitted protocol just to be sure there are no "clinical hold issues".


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