Written documentation of the transfer of regulatory obligations from a sponsor to a CRO is a requirement under 21 CFR 312.52. Such an agreement is commonly part of the contract between the CRO and sponsor, but it could also be a stand-alone document. Because it has compliance implications, it should be signed by both parties whether as part of the contract or stand-alone. On the part of the sponsor, it can be signed by whoever is given the authority to make such decisions and that depends on the size and structure of the sponsor's organization.
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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: 02-Aug-2021 17:04
From: Anonymous Member
Subject: Transfer of obligations - signatures required?
This message was posted by a user wishing to remain anonymous
Is a Transfer of Regulatory Obligations required to be signed by both parties (CRO and Sponsor) for submission to an IND? I have seen the TORO is attached as part of the contract, e.g., an appendix, with spots for signatures and now more recently without any place to sign. Who could or should sign on behalf of the Sponsor?