This message was posted by a user wishing to remain anonymous
I have a somewhat different perspective. The investigator information is technically part of the protocol (see 21 CFR 312.23(a)(iii)), and one of the things that FDA must review in determining whether to place an IND or an individual protocol on clinical hold is the qualifications of the investigators. If investigator information is missing, they cannot determine whether the investigators are qualified.
I personally know of two instances when the FDA project manager called just before the 30th day of the initial IND submission and advised the company that they needed to provide information on at least one investigator (CV plus 1572), or that FDA would have to put the IND on hold. So I would not even consider submitting an initial IND without this required information.
I agree than the risk is much less for subsequent protocols; however, it is my practice to include information on at least one investigator with the protocol submission, since, per the regulations, it is required. I have found that Clinical can get at least one if they know in advance that it will be needed.
When you submit a new IND or a Protocol Amendment: New Protocol, you are telling FDA that you are ready to start the study, so everything that is required to be submitted should be submitted. (If you are trying to get FDA feedback on a protocol, submit it as a request for review, not as a Protocol Amendment: New Protocol. )
The 3674 is required with INDs and with new protocols, but it is not part of the protocol and not something that FDA specifically needs to review for determining whether the study can reasonably proceed. If your protocol is NOT an applicable clinical trial (ACT), you can complete the 3674 easily, since you will check box B. (Even if you are registering the protocol voluntarily rather than as an ACT, the form will not let you include the NCT number in Box B; the NCT number on the form is only for ACTs, and that goes in Box C.) If you are going to register/have registered the protocol voluntarily, you can indicate in the submission cover letter that this will be / has been done and put the NCT number there if it has already been assigned.
For an ACT, you have until 21 days after the first subject has been enrolled to register the trial on clinicaltrials.gov (although it's not recommend to wait that long since some journals will not publish results if the trial wasn't registered prior to subject enrollment). If you are submitting an ACT in the initial IND or with a new protocol and you don't have the NCT yet, I would note in the cover letter that you recognize that the trial is an ACT, and that it will be registered within 21 days of first subject enrollment, and that you will submit the 3674 when the NCT is assigned. I have done that before with no problem. As someone said, you could get a non-hold comment on this, and of course you should submit the form as soon as possible.
Original Message:
Sent: 22-Oct-2021 08:41
From: Glen Park
Subject: IND Amendment Submission
For an original IND, investigator information is required (21 CFR 312.23 IND Content and Format). For protocol submissions to an active IND, I do not believe the regulation requires that the protocol be accompanied by investigator information, but it must be submitted within 30 days (21 CFR 312.30). On the other hand, I do not know why one would submit a protocol that is essentially incomplete.
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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
Original Message:
Sent: 21-Oct-2021 09:35
From: Anonymous Member
Subject: IND Amendment Submission
This message was posted by a user wishing to remain anonymous
Hi Everyone,
Regarding Submission for a clinical study, if the protocol is final, got the IRB Approval and good to go, but the investigators info and forms etc. are still awaited, is it okay to do a separate submission of protocol (protocol, 1571 etc.) and rest of the documents (1572, 3674, etc.)?
Thank you in advance