The Investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the Sponsor, IRB/IEC, and/or regulatory authorities.

He/she should be aware of, and should comply with, GCP and the applicable regulatory requirements.

Principal Investigator

A person responsible for the conduct of the clinical trial at the 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.


Any individual member of the clinical trial team designated and supervised by the Investigator at a trial site to perform clinical trial related procedures and/or to make important trial related decisions (e.g. associate, residents, and research fellows).