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01 September 2011


Marci Aderiye


Thanks for the infomrative article. Can you comment on the contents of the "Transfer of Obligation" letter under 312.52. I could see how these two documents could complement/stand in for each other.

Nancy Stark

Hi Marci,
The "Transfer of Obligation" letter under 312.52 has to do with a sponsor transferring study obligations to a CRO; something that is not allowed in devices. Meaning, a device manufacturer can hire a CRO, but if the CRO makes a mistake the sponsor gets the warning letter.

A Clinical Trials Agreement is a (non-FDA) phrase referring to the financial arrangements between an investigative site and a sponsor.

In the drug world, I can imagine a situation where a manufacturer hires a CRO to act as sponsor and CTA would be between the site and the CRO.

I have never known of this to happen in the device world. (But anything is possible....)

Anyone out there have some experience with this?

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