Regulatory Open Forum

​​Has anyone submitted an initial IND without submitting the principal investigator's name, affiliation, and qualifications? I am currently working on an initial IND for a Phase 3 multicenter study and a principal/coordinating investigator has not yet been selected. Do I need to wait until at least the principal investigator's information is available to submit the initial IND, or could investigator information be added to the IND after it's opened?

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Barbara Militzer
Sr. Director, Regulatory Affairs
Canonsburg PA
United States
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My experience when submitting an IND without an investigator was a quick response from the review division that, and here I don't remember the exact response, whether it was that they would not file the IND without an investigator or that they would not clear it until an investigator was submitted. Either way, we were not going to be able to proceed without an investigator.

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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 09-Sep-2019 16:54
From: Barbara Militzer
Subject: Initial IND Submission Without Identification of Principal Investigator

​​Has anyone submitted an initial IND without submitting the principal investigator's name, affiliation, and qualifications? I am currently working on an initial IND for a Phase 3 multicenter study and a principal/coordinating investigator has not yet been selected. Do I need to wait until at least the principal investigator's information is available to submit the initial IND, or could investigator information be added to the IND after it's opened?

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Barbara Militzer
Sr. Director, Regulatory Affairs
Canonsburg PA
United States
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I also agree with Glen.  It is our practice not to submit an IND unless there is a PI named.  It may appear to the agency reviewers that the IND submitters are not fully prepared to execute the protocol.

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Robert Schiff PhD, RAC, CQA, FRAPS
CEO
Schiff & Company, Inc.
1120 Bloomfield Ave., Suite 103
West Caldwell, NJ 07006
rschiff13@aol.com
973-568-3361
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Original Message:
Sent: 10-Sep-2019 08:38
From: Glen Park
Subject: Initial IND Submission Without Identification of Principal Investigator

My experience when submitting an IND without an investigator was a quick response from the review division that, and here I don't remember the exact response, whether it was that they would not file the IND without an investigator or that they would not clear it until an investigator was submitted. Either way, we were not going to be able to proceed without an investigator.

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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 09-Sep-2019 16:54
From: Barbara Militzer
Subject: Initial IND Submission Without Identification of Principal Investigator

​​Has anyone submitted an initial IND without submitting the principal investigator's name, affiliation, and qualifications? I am currently working on an initial IND for a Phase 3 multicenter study and a principal/coordinating investigator has not yet been selected. Do I need to wait until at least the principal investigator's information is available to submit the initial IND, or could investigator information be added to the IND after it's opened?

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Barbara Militzer
Sr. Director, Regulatory Affairs
Canonsburg PA
United States
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Hi Barbara,

I have seen sponsors submit an initial IND without the Investigator 1572/CV. The usual method of action is to make note in the cover letter that there is not yet an approved investigator to conduct the trial, and confirm that the information will be submitted during the review period for the IND, before the study is initiated.

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Allison Steffen
Manager, Regulatory Operations
Hatboro PA
United States
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Original Message:
Sent: 09-Sep-2019 16:54
From: Barbara Militzer
Subject: Initial IND Submission Without Identification of Principal Investigator

​​Has anyone submitted an initial IND without submitting the principal investigator's name, affiliation, and qualifications? I am currently working on an initial IND for a Phase 3 multicenter study and a principal/coordinating investigator has not yet been selected. Do I need to wait until at least the principal investigator's information is available to submit the initial IND, or could investigator information be added to the IND after it's opened?

------------------------------
Barbara Militzer
Sr. Director, Regulatory Affairs
Canonsburg PA
United States
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Agree with Allison

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Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC
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Original Message:
Sent: 10-Sep-2019 08:42
From: Allison Steffen
Subject: Initial IND Submission Without Identification of Principal Investigator

Hi Barbara,

I have seen sponsors submit an initial IND without the Investigator 1572/CV. The usual method of action is to make note in the cover letter that there is not yet an approved investigator to conduct the trial, and confirm that the information will be submitted during the review period for the IND, before the study is initiated.

------------------------------
Allison Steffen
Manager, Regulatory Operations
Hatboro PA
United States

Original Message:
Sent: 09-Sep-2019 16:54
From: Barbara Militzer
Subject: Initial IND Submission Without Identification of Principal Investigator

​​Has anyone submitted an initial IND without submitting the principal investigator's name, affiliation, and qualifications? I am currently working on an initial IND for a Phase 3 multicenter study and a principal/coordinating investigator has not yet been selected. Do I need to wait until at least the principal investigator's information is available to submit the initial IND, or could investigator information be added to the IND after it's opened?

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Barbara Militzer
Sr. Director, Regulatory Affairs
Canonsburg PA
United States
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I believe you need a signed Form FDA 1572 from a participating PI in order for the IND to be opened.  Recently we tried submitting a 1572 signed by our CRO overseeing the clinical trial and that was unacceptable.  At least for the FDA Division (Derm & Dental) we were working with.

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Tom
Senior Director, Regulatory Affairs CMC
Chicago
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Original Message:
Sent: 09-Sep-2019 16:54
From: Barbara Militzer
Subject: Initial IND Submission Without Identification of Principal Investigator

​​Has anyone submitted an initial IND without submitting the principal investigator's name, affiliation, and qualifications? I am currently working on an initial IND for a Phase 3 multicenter study and a principal/coordinating investigator has not yet been selected. Do I need to wait until at least the principal investigator's information is available to submit the initial IND, or could investigator information be added to the IND after it's opened?

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Barbara Militzer
Sr. Director, Regulatory Affairs
Canonsburg PA
United States
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My experience has been similar to Tom and Glen. We tried to submit one initial IND without the investigator information and were requested to submit it right away for the review to continue.

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Kala Patel RAC
Senior Director, Regulatory Affairs
Princeton NJ
United States
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Original Message:
Sent: 09-Sep-2019 16:54
From: Barbara Militzer
Subject: Initial IND Submission Without Identification of Principal Investigator

​​Has anyone submitted an initial IND without submitting the principal investigator's name, affiliation, and qualifications? I am currently working on an initial IND for a Phase 3 multicenter study and a principal/coordinating investigator has not yet been selected. Do I need to wait until at least the principal investigator's information is available to submit the initial IND, or could investigator information be added to the IND after it's opened?

------------------------------
Barbara Militzer
Sr. Director, Regulatory Affairs
Canonsburg PA
United States
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