A protocol deviation or violation is any departure from the study procedures or treatment plans as specified in the IRB-approved protocol. Protocol deviations occur when an investigator does not ...

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

Reports of noncompliance or protocol deviations must be submitted to the IRB within 48 hours of discovery. Please see this guidance document on how to submit reports. An "incident" should be submitted ...

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...

The US Food and Drug Administration (FDA) has issued draft guidance that proposes a uniform system for classifying protocol deviations in clinical studies to assist sponsors, clinical investigators, ...

In this free webinar, gain insight into why eligibility is a high-impact point for protocol deviation prevention. The featured speakers will discuss how to drive protocol compliance with centralized ...

Research studies may result in the implementation of unapproved changes to IRB-approved research plans or failure to comply with established regulations, policies, and procedures. Any action or ...

Failure to follow the agreed-upon protocol for a clinical trial for an investigational pain pill product has earned a clinical investigator a Warning Letter from the US Food and Drug Administration ...