I have not worked with a client yet with any questions on the new 1571. However, it is essential, in my view, to have a very robust agreement that spells out with as much specificity as possible exactly which duties are being transferred to the CRO and which are being retained by the sponsor.
I have seen too many times where a sponsor had thought a contract transferred a duty to a CRO or other vendor only to learn that the contract was silent or vague on that subject. You don't want to find yourself in a situation as a sponsor where the task needs to be done and you as the sponsor don't have the expertise to do it and thought you had budgeted for the CRO to do it. The CRO likely will say to you then that they would be happy to do the task, but that it will result in a change to the contract that you, the sponsor, will have to pay for.
And, frrom an FDA perspective, if it's not detailed properly on the 1571 as transferred to the CRO, the regulatory duty remains legally with the sponsor.
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Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
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San Diego, CA 92101-4681
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maswit@duanemorris.com Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.
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Original Message:
Sent: 12-17-2012 17:35
From: Jeri Beltman
Subject: New 1571 form & transfer of obligations
My company recently started using the new 1571 form [FORM FDA 1571 (10/12)]. As part of that form, there is space to fill in the contract research organizations and transfer of obligations (page 3, with allowance for additional continuation pages). When using this new form, is one still required to prepare a transfer of obligations list or table, or does the new 1571 form negate the need for a separate transfer of obligations document? What is the standard practice when using the new 1571 form? If any of you have been in direct contact with anyone at FDA regarding the new 1571 form and the need for transfer of obligations documents, it would be of interest to hear about that exchange. Thanks!
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Jeri Beltman RAC
Director, Regulatory Affairs
Clovis Oncology
San Francisco CA
United States
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