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 ...

Ethical GmbH, the Swiss company providing personalized software solutions for clinical research committees management, has developed a new software solution designed to simplify the protocol deviation ...

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 ...

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 ...

Using KRIs or SDM, sponsors can detect a variety of emerging risks, including inadequate adverse-event reporting, protocol ...