Regulatory Submissions of Protocol Amendments: Processes, Timelines, and Best Practices in Clinical Trials
Regulatory Submissions of Protocol Amendments: Processes, Timelines, and Best Practices in Clinical Trials Regulatory Submissions of Protocol Amendments in Clinical Trials: Navigating Requirements and Ensuring Compliance Submitting Protocol Amendments to regulatory authorities and ethics committees is a critical step in maintaining compliance and protecting participant safety in clinical trials. Substantial amendments must be formally reviewed…