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 ...

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 ...

The relationship between trial registration and publication is not straightforward. Although registries and editorial requirements receive some attention from researchers, study protocol changes, ...

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 ...

The limited information provided in this scenario creates additional questions that the Great Eastern University IACUC must address before it can provide approval for this protocol amendment. Would ...