Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear community,

We (as a sponsor) submitted an IND back in Oct. 2021. A CRO helped us with eCTD submission.
Later, we contracted the same CRO as our clinical CRO. There was a detailed appendix with activities in the contract, but there was no mention of 21CFR312. In addition, the contract was signed in Nov. 2021. So there was no TORO attached to the 1571 form for the initial IND, and the #15 of 1571 was marked as "No." and there was no 1.3.1.4.

Since the signing of the contract, the CRO was acting as a representative of us (sponsor) and conducted investigator selection, site visits, etc. 

My questions:
1) is it required to report to FDA about the transfer of obligations? If so, what is the best way to do it now? Re-submit 1571? Should we submit 1.3.1.4? 
2) Can the list in contract appendices count as the transfer of obligations agreement? If we draft and sign TORO now, how can we explain that the CRO acted as our representative already and conducted some clinical activities? 
3) what is the difference between 1.3.1.4 (Transfer of Obligations) and the attachment to 1571 (TORO)? If they are the same, why does FDA ask for the same document in two different places? 

Thank you!​

I suggest you resubmit 1571. Check "yes" in box 15. Complete boxes 16 & 17. In box 15 Continuation we include the statement "The obligations transferred for clinical study XXX is provided in Module 1.3.1.4 Transfer of Obligations." Submit 1.3.1.4 since it has not been submitted yet - we create the 1.3.1.4 document from the appendix from the contract.  For future submissions, if they are related to clinical, we check "yes" in box 15. Complete boxes 16 & 17. And in box 15 Continuation we include the statement with a link to 1.3.1.4.  No need to resubmit 1.3.1.4 document since it has already been submitted.  If future submission are not related to clinical, we leave box 15 blank and don't check anything. Leave box 15 continuation page blank.  I don't think you need to explain why TORO wasn't submitted before or that CRO was conducting some of the activities before, just submit once you have it.

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Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
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Original Message:
Sent: 19-May-2022 20:54
From: Anonymous Member
Subject: Transfer of obligation (did not report to FDA) - 1571 form - IND 1.3.1.4

This message was posted by a user wishing to remain anonymous

Dear community,

We (as a sponsor) submitted an IND back in Oct. 2021. A CRO helped us with eCTD submission.
Later, we contracted the same CRO as our clinical CRO. There was a detailed appendix with activities in the contract, but there was no mention of 21CFR312. In addition, the contract was signed in Nov. 2021. So there was no TORO attached to the 1571 form for the initial IND, and the #15 of 1571 was marked as "No." and there was no 1.3.1.4.

Since the signing of the contract, the CRO was acting as a representative of us (sponsor) and conducted investigator selection, site visits, etc.

My questions:
1) is it required to report to FDA about the transfer of obligations? If so, what is the best way to do it now? Re-submit 1571? Should we submit 1.3.1.4?
2) Can the list in contract appendices count as the transfer of obligations agreement? If we draft and sign TORO now, how can we explain that the CRO acted as our representative already and conducted some clinical activities?
3) what is the difference between 1.3.1.4 (Transfer of Obligations) and the attachment to 1571 (TORO)? If they are the same, why does FDA ask for the same document in two different places?

Thank you!​