A sponsor is permitted to charge for an investigational drug but must provide what documentation?
In accordance with the ICH GCP Guideline, prior to initiating a trial, which of the following should define, establish, and allocate all trial-related duties and functions?
For a study with a significant risk investigational medical device that could optimize the effects of radiation therapy on cancer tumors, the investigational plan states mild burns are an anticipated effect. One subject developed severe burns with blistering. In accordance with the CFR, this effect must be reported to the sponsor and the IRB/IEC as soon as possible and at most how long after the investigator first learns of the effect?
The reviewing IRB/IEC determined that a minimal risk sponsor-investigator study is exempt from IRB/IEC review. How often, if ever, is the sponsor-investigator required to submit a continuing review to the IRB/IEC?
Why would a Phase IV study be conducted?
