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What is a consent agreement?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

Consent agreements generally take one of two forms:

  • the investigator agrees to be disqualified and is no longer eligible to receive investigational products. This agreement has the same effect as a disqualification after a Part 16 hearing and terminates the disqualification administrative proceeding; or,
  • the investigator, after discussions with the FDA, including an explanation of the alleged violations in writing or at an informal conference, agrees to specific restrictions in the use of investigational products, such as oversight of the investigator’s conduct of an investigational study by an individual acceptable to both the investigator and FDA.

If the investigator violates the restricted consent agreement, FDA can reinitiate the disqualification proceeding.

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