Question

Terrific Pharmaceuticals approaches Dr Kildare, a specialist cardiologist, about being an investigator for a Phase III trial of Youbeautinol ® , a new Ace inhibitor. The trial will be double-blind placebo-controlled.

a. What information and documentation must the sponsor provide to allow Dr Kildare to make an informed decision?

b. What information and documentation must Dr Kildare provide to Terrific Pharmaceuticals?

c. What approvals must Dr Kildare obtain before the trial can commence?

Answer 1

a. Phase III trial is a therapeutic confirmatory study that means product is already approved or marketed in another country. The sponsor has to provide following documents to the investigator so that he can make informed decision.

Product information, Investigator undertaking to be filled Investigator brochure, Informed consent, proposed protocol, Regulatory status in other countries. Form FDA 1572, Clinical trial agrement.

b. The following documanttion must provide to terrific pharmaceuticals by Dr. Kildare.

Undertaking by the investigator filled and signed by all Principal and co-ininvestigators, Curriculum vitaeof all investigators, Medical registration certificates, ICH-GCP certifications.

c. Mr. Kildare must take take approval from Institutional review board (IRB)/ Institutional ethics committee (IEC)/ Independent Ethics committee before thay commence clinical trial