Minimum Qualifications of an Investigator

The regulations do not specify the minimum requirements nor do the regulations specify what qualifications an investigator must have. All it states is that an investigaor should be qualified by training and experience to conduct a clinical investigation.

Sponsors have discretion in determining what qualifications, training, and experience will be needed, based on the general recognition that this would include familiarity the local law, good clinical practice (GCP) regulations (21 CFR Part 312) and standards (ICH E6) for the conduct of clinical studies.

It may well be part of a Sponsor´s SOPs to only select physicians as investigators. That certainly is within their rights. It is good, however, for sponsor staff to realise that this is a company provision, not an industry requirement.wow gold

Does an Investigator have to be a Physician?

The regulations do not require that the investigator be a physician. Sponsors are required to select only investigators qualified by training and experience as appropriate experts to investigate the drug (21 CFR 312.53(a)). In the event the clinical investigator is a non-physician, a qualified physician (or dentist, when appropriate) should be listed as a subinvestigator for the trial and should be responsible for all trial-related medical (or dental) decisions. (ICH E6 section 4.3.1) wow gold