Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 115

1 What is the role of the sponsor?

2 What other individuals or parties may assist the sponsor with trial‐related duties, and under what conditions?

3 What is the role of the investigator?

4 What other individuals or parties may assist the investigator with trial‐related duties, and under what conditions?

5 What are the sponsor's responsibilities before the trial commences, during the conduct of the trial, and after completion or termination of a trial?

6 What are the investigator's responsibilities before the trial commences, during the conduct of the trial, and after completion or termination of a trial?

7 Overheard:“We should have ethics committee approval of the protocol tomorrow so we will enroll the patient the following day. We can then submit to the study to the regulatory authority.”Physician at a clinic who received donated study drug from a manufacturer to conduct their own clinical trial. This physician will otherwise wholly finance and resource the study.Comment and discuss:What are the GCP and regulatory responsibilities of this “investigator”?Is the investigator violating any GCP requirement? If yes, which?