Bioequivalence and Bioavailability Forum

Dear Irukulla,

According to Schedule Y:
All trial Investigator(s) should possess appropriate qualifications, training and experience and should have access to such investigational and treatment facilities as are relevant to the proposed trial protocol. A qualified physician (or dentist, when appropriate) who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions.

Indian GCP:
§ 3.3.1: The investigator should be qualified by education, training and experience to assume responsibility for the proper conduct of the study and should have qualifications prescribed by the Medical Council of India (MCI).
§ 3.3.2: A qualified Medical Practitioner (or a Dentist, when appropriate) who is an Investigator or a Co-Investigator for the study should be responsible for all study related medical decisions.

ICH GCP, § 4.3.1: A qualified physician (or dentist, when appropriate) who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions.

In many countries it would not be allowed legally for a pharmacist to be an investigator. In some other countries it may be acceptable for some types of clinical trials (observational...), as long as a medically qualified sub-investigator is available to take medical decisions. For a BE trial I would not consider it appropriate.

Regards
Ohlbe

Hello ISK,

in addition to what Ohlbe wrote I can add that under WHO's proposed implementation of GCP a non-MD (/ non-dentist) can serve as PI without any explicit exceptions for BE or other trials but the need for available medical staff remains. I have come across it several times in BE studies. It is a good idea to have a crystal-clear delegetation log in such cases
See here.

Local rules and regulations should of course also be respected.