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 ...
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As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
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 ...
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...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 EC should review - Who is the sponsor of clinical trial? Who is the investigator? What does CT agreement describe about finance/sponsor responsibility? The sponsor is a company manufacturing a ...
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