Protocol training [Study Per­for­mance]

posted by Ohlbe – France, 2018-02-05 15:31 (2350 d 12:17 ago) – Posting: # 18349
Views: 6,500

Dear anky1212,

❝ I would like to add that pharmacist have access to IRB approved protocol and can refer to that directly.

Having access to a document and reading it is not quite the same thing...

❝ But Protocol training of the same is required by Principal investigator or not.

Please refer to ICH GCP:

§ 4.2.4: The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.

Which does not mean that he should train them himself, only ensure that they are informed. Which could be limited to ensuring that they have read and understood the protocol and any other relevant document. If you have a system in place to document that the pharmacist has read the protocol, and to document his assessment of any impact it may have on what he is supposed to do, this could be OK.

But don't forget the new section 4.2.5:
The investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and functions conducted at the trial site.


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