ICH-GCP training of site staff

ICH-GCP says that the investigator should ensure that all persons assisting the trial are adequately informed about the protocol, the investigational product(s), and their trial related duties and functions (4.2.4). The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties (4.1.5).

If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator (PI) (1.34).
Thus, to live up to ICH-GCP, site staff, who are working under the overall responsibility of the Principal Investigator, need to be documentedly trained about the protocol, the IP and their duties and functions. It is not an absolute requirement of a study coordinator or sub-investigator to be trained on ICH-GCP.

Sit staff performing (all or a part of) the informed consent procedure make for another story. ICH-GCP says that in obtaining and documenting informed consent, the investigator should comply with the applicable regulatory requirement(s), and should adhere to GCP and to the ethical principles that have their origin in the Declaration of Helsinki (4.8.1). By virtue of that statement, I would expect anyone involved in the informed consent procedure to be formally trained on ICH-GCP.

That’s the guideline, and the outline of the minimum standard.

Which brings us to golden standard. Ideally, anyone playing an active role in a clinical trial site team should be appropriately trained on the international guidelines as ICH-GCP as well as the applicable regulatory requirement(s), besides the protocol, IP, duties and functions as outlined in GCP. And often they are, even if the CV does not reflect that.
An important aspect is proper training documenting. Formal ICH-GCP training, in a course which provides a certificate is one thing. Those are usually listed if attended. More often not listed are training moments which occur in the course of running trials. Sub-investigators, research nurses, study coordinators, people holding any of those kind of positions commonly attend a number of initiation meetings per year. Sometimes additionally some investigator meetings. At each of those occasions ICH-GCP training is provided. However those are most often not documented. Anyone who has not attended a full ICH-GCP training should update their CV (at least) annually to reflect attendance of those small sessions and document ICH-GCP training. Anyone who HAS attended a full ICH-GCP training should update their CV (at least) annually to reflect attendance of those small sessions as documentation of continued refresher training.

This topic came directly from the field, thanks Minal.wow gold