Join Catherine Tyner, Head of Clinical Strategy, AG Mednet; and Craig McLendon, former Vice President, Adjudication, ...
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
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 ...
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...
Variables with time-varying effects and the Cox model: Illustration with the role of estrogen receptor status in breast cancer No significant financial relationships to disclose. This is an ASCO ...
As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of "Protocol Not ...
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 ...
Prior to data collection, this study received approval from the Investigational Review Board and Brigham and Women's Hospital Pharmacy Peer Review Committee. A retrospective chart review was conducted ...
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