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 ...

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 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 ...

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 ...

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 Public Health Service Policy and the Animal Welfare Act both state that the IACUC should “review and approve, require modifications in (to secure approval), or withhold approval of proposed ...

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 ...

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 ...