Posting: # 20481
Should the sponsor's medical expert be a registered physician for local regulation? Apart from this he or she must possesses education in allopathic medicine stream? Please opine with any guideline reference.
Edit: Please follow the Forum’s Policy. [Helmut]
@ yatish gosai
Posting: # 20483
» Should the sponsor's medical expert be a registered physician for local regulation?
You should know your local regulation better than we do.
The term “sponsor’s medical expert” does not exist in any of the relevant ICH guidelines (E6(R2), E8(R1)). On the sponsor’s side I have seen – apart from physicians – pharmacists, dentists, biologists, (bio)chemists, and even veterinarians. This is in line with E6(R2), which states in
5.3 Medical Expertise
Furthermore, even if the project manager (the most common term) of the sponsor – in any country – is a physician, how likely would he/she be registered in say, India?
» Apart from this he or she must possesses education in allopathic medicine stream?
As I wrote above, no specific requirements for the sponsor. Of course, the principal investigator has to be sufficiently qualified/trained (E6(R1) Sections 2.7, 2.8, 4.1.1, and 5.6.1) and the sponsor has to assure that. The ultimate responsibility for compliance with GCP resides always with the sponsor (Section 5.2.1).
I would never ever delegate the duties of a PI to a homeopath.
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