I am not sure you can make that distinction. 312.3 defines "contract research organization" as a person.
"Contract research organization means a person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration."
I think that any contractor, i.e., not employee of the Sponsor, may qualify as needing to be covered under a TORO. I would say that would be anyone that has signed a contract to perform work for a Sponsor regardless of whose SOPs are being followed
RE: what activities should be covered under a TORO, an FDA investigator once told me that any statement in 312 that says "shall" should be considered an obligation or either the Sponsor or investigator.
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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: 22-Aug-2022 09:21
From: Anonymous Member
Subject: Sponsor Transfer of Responsibility
This message was posted by a user wishing to remain anonymous
I know I am coming late to this thread, but I am wondering if you can assume that any contractor or consultant that is working under your SOPs and is being supervised internally does not need a TORO.
Original Message:
Sent: 13-Aug-2021 15:58
From: Anonymous Member
Subject: Sponsor Transfer of Responsibility
This message was posted by a user wishing to remain anonymous
I have a question as more and more companies use consultants and contractors re: the transfer of obligation list on the 1571 (or Module 1.3.1.4 if we choose to submit it there) gets longer and the lines blurred.
I typically advise that it's anyone handling data, monitoring, PhV services, sample collections, data analysis, etc. are historically listed; any auditable services.
I know the 312.52 regulation states, but this is a common question and it does get blurry.
A good example would be individual statisticians (or statistical vendors) who are handling data and analyzing data. Ultimately the company signs off on the analysis but how is this different from a monitoring CRO where there is company has oversight on the data coming in that is historically listed; would you include them? Would you include a vendor transporting samples as well?
Any advice on how FDA helps to define these lines?
Thanks for your input or opinion.