CFR section
21 CFR 312.52(a): Transfer of obligations to a contract research organization
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart D-Responsibilities of Sponsors and Investigators
Key facts
| Citation | 21 CFR 312.52(a) |
|---|---|
| Section | Transfer of obligations to a contract research organization |
| Part | PART 312-INVESTIGATIONAL NEW DRUG APPLICATION |
| Subpart | Subpart D-Responsibilities of Sponsors and Investigators |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | (a) A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research organization. Any such transfer shall be described in writing. If not all obligations are transferred, the writing is required to describe each of the obligations being assumed by the contract research organization. If all obligations are transferred, a general statement that all obligations have been transferred is acceptable. Any obligation not covered by the written… |
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