Comment from ACRO (Association of Clinical Research Organizations)
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Summary: The Association of Clinical Research Organizations (ACRO) supports the draft guidance on protocol deviations but recommends specific modifications to clarify roles and responsibilities. They argue that the current wording may place an undue burden on investigators for identifying and reporting deviations, suggesting instead that sponsors and CROs should maintain primary oversight and provide clear instructions to sites.
February 28, 2025
Dat Doan, Center for Drug Evaluation and Research
James Myers, Center for Biologics Evaluation and Research
Soma Kalb, Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
RE:ACRO comment submission on draft guidance on
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
[FDA-2023-D-5016-0001]
Dear Mr. Doan, Mr. Myers, and Dr. Kalb,
The Association of Clinical Research Organizations (ACRO) is pleased to submit the attached comment on this public consultation.
ACRO's comment is attached here as a PDF (please see attachment).
Please contact ACRO if we can provide additional information or answer any questions.
Respectfully submitted,
Karen Noonan, Senior Vice President, Global Regulatory Policy
ATTACHMENT: ACRO Comment (PDF)