Bioequivalence and Bioavailability Forum

Dear Vishal,

This may depend on national regulations. Check the regulations of the country where you intend to run your trial.

According to the ICH GCP guideline:
- the investigator is defined (§1.34) as A person responsible for the conduct of the clinical trial at a trial site. 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 principle investigator.
- the subinvestigator is defined (§1.56) as Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows).
- section 3.1.2. states that The IRB/IEC should obtain [...] the investigator's current curriculum vitae and/or other documentation evidencing qualifications.
- section 3.1.3. states that The IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.

I would conclude that the ICH GCP guideline only requests the submission of the CV of the investigator, not the CV of subinvestigators. In the case of a BE trial (which is what this forum is about), you will have only one trial site and one investigator or principle investigator; others would be considered as subinvestigators operating under his responsibility and supervision, with a proper and formalised delegation of tasks. I would consider that you only need to submit one CV to the IEC/IRB. Once again, this is only according to the ICH GCP guideline and national regulations or guidelines may be different.

Regards
Ohlbe