Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We have always submitted Form 1572 from at least one investigator with initial INDs, and it seems most people in this forum do as well. However, when reviewing the "Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs - Frequently Asked Questions – Statement of Investigator (Form FDA 1572)", the answer to Question 6 (Does the 1572 need to be submitted to FDA?) clearly states that there is no need to submit Form 1572. Am I missing a more recent FDA Guidance or is this mostly done out of an abundance of caution?

It is correct that it is not required that you submit a 1572 to an IND, but it is required to submit the information that is contained on a 1572 for a study conducted under an IND. It is my experience that FDA will generally not file an IND without identification of at least one investigator. Therefore, the standard practice is to file the 1572 to meet that regulatory requirement.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 05-Apr-2023 14:25
From: Anonymous Member
Subject: Form 1572 Requirement for Initial IND

This message was posted by a user wishing to remain anonymous

We have always submitted Form 1572 from at least one investigator with initial INDs, and it seems most people in this forum do as well. However, when reviewing the "Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs - Frequently Asked Questions – Statement of Investigator (Form FDA 1572)", the answer to Question 6 (Does the 1572 need to be submitted to FDA?) clearly states that there is no need to submit Form 1572. Am I missing a more recent FDA Guidance or is this mostly done out of an abundance of caution?

My understanding is that while the 1572 may not be a requirement, you do have to address/submit all of the information that is captured on the 1572 in some manner.  So it just makes sense to do it via the 1572. I've had experience where FDA did not accept our initial IND because we did not include a signed 1572 from an investigator participating in the study - we tried submitting a 1572 signed by the CRO since we didn't have an investigators committed to the study at the time, but FDA did not accept. So I would be sure to submit a 1572 - this is for the initial IND submission only.  Subsequent protocol submission once the IND is open do not need a 1572 when submitting the protocol - you can submit them at a later date. 

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Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
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Original Message:
Sent: 05-Apr-2023 14:25
From: Anonymous Member
Subject: Form 1572 Requirement for Initial IND

This message was posted by a user wishing to remain anonymous

We have always submitted Form 1572 from at least one investigator with initial INDs, and it seems most people in this forum do as well. However, when reviewing the "Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs - Frequently Asked Questions – Statement of Investigator (Form FDA 1572)", the answer to Question 6 (Does the 1572 need to be submitted to FDA?) clearly states that there is no need to submit Form 1572. Am I missing a more recent FDA Guidance or is this mostly done out of an abundance of caution?

This message was posted by a user wishing to remain anonymous

Hello, it is important to carefully read the second sentence in the guidance:  

"Many sponsors submit the 1572 to FDA, however, because it collects, in one place, information that must be submitted to FDA under 21 CFR 312.23(a)(6)(iii)(b)." 

As others have alluded to, you do need to provide most of the information that is on the 1572, as it is required by 21 CFR 312.23(a)(6)(iii)(b); this information includes subinvestigators, research facilities, and IRB information.   Your choice is to provide the 1572, where the information is already collected, or to provide that information in a separate document.  It is typically much simpler to just provide the 1572.

I would note that this investigator information is required when new protocols are submitted to the IND, it is not just for an initial IND.  For purposes of regulatory submissions, the investigator information is part of the protocol.  I always ask Clinical to get this information on at least one investigator for new studies to submit with the protocol (Protocol Amendment: New Protocol) to meet the requirement. Even though I would not advocate omitting the investigator information with a new protocol, since it is required, I would agree that FDA is much less likely to put the study on clinical hold if you omit this required information for a new protocol under an IND that is already in effect.  

Original Message:
Sent: 05-Apr-2023 14:25
From: Anonymous Member
Subject: Form 1572 Requirement for Initial IND

This message was posted by a user wishing to remain anonymous

We have always submitted Form 1572 from at least one investigator with initial INDs, and it seems most people in this forum do as well. However, when reviewing the "Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs - Frequently Asked Questions – Statement of Investigator (Form FDA 1572)", the answer to Question 6 (Does the 1572 need to be submitted to FDA?) clearly states that there is no need to submit Form 1572. Am I missing a more recent FDA Guidance or is this mostly done out of an abundance of caution?