Comment from ACRO (Association of Clinical Research Organizations)
AnonymousSupportTrade association
Summary: The Association of Clinical Research Organizations (ACRO) supports the FDA's draft guidance on protocol deviations but requests specific modifications to improve clarity and international alignment. They argue that certain terminology in the draft creates confusion with EU and UK standards, potentially leading to over-reporting, and they advocate for a more risk-based, harmonized approach.
September 17, 2025
Dr. Chrissy J. Cochran, PhD, Director of OBMI, Office of Inspections and Investigations (OII)
Mr. Dat Doan, Center for Drug Evaluation and Research
Mr. James Myers, Center for Biologics Evaluation and Research
Dr. Soma Kalb, Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
RE:Draft Guidance on Protocol Deviations for Clinical Investigations of Drugs, Biological Products and Devices--
ACRO request for targeted modifications to the draft guidance in order to strengthen its risk-based framework, mitigate over-reporting, and align with EU and UK guidance
Dear Dr. Cochran, Mr. Doan, Mr. Myers, and Dr. Kalb,
The Association of Clinical Research Organizations (ACRO) is pleased to submit the enclosed comment on the draft guidance.
ACRO's comment is attached here as a PDF.
Please see PDF attachment.
Respectfully submitted,
Karen Noonan, Senior Vice President, Global Regulatory Policy, ACRO
ATTACHMENT: ACRO comment (PDF)