Bioequivalence and Bioavailability Forum

Dear drgopal,

❝ can anyone explain the responsibilities of principal investigator and

❝ clinical investigator? what is the difference in their roles?

OK, let's try and clarify these wordings, which are often misused.

For the clinical part of the trial, please refer to the definitions in the ICH GCP guideline. The guideline gives a definition for the investigator (§1.34):

"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 principal investigator. See also Subinvestigator."

The principle investigator is not defined further. A definition of the subinvestigator is given in §1.56. To be exhaustive you can have a look at the definition of the coordinating investigator in 1.19.

For the bioanalytical part of the trial, please refer to the OECD GLP guideline. The Principle Investigator is defined in section 1, §2.2.7:

"Principal Investigator means an individual who, for a multi-site study, acts on behalf of the Study Director and has defined responsibility for delegated phases of the study. The Study Director's responsibility for the overall conduct of the study cannot be delegated to the Principal Investigator(s); this includes approval of the study plan and its amendments, approval of the final report, and ensuring that all applicable Principles of Good Laboratory Practice are followed."

❝ Should the investigator (Principal Investigator/Clincal investigator) be

❝ present at the time of receipt, dispensing, storage and disposal of IPs?

Not necessarily. Have a look at the ICH GCP guideline, section 4.6.

Regards
Ohlbe

HS: maybe you could also add a link to the OECD GLP guideline, as well as to the FDA, EU and WHO versions, in your guideline page ? I must have the links somewhere if needed.