Introduction
Good Clinical Practice (GCP) is an international ethical and scientific quality standard
fordesigning, conducting, recording and reporting trials that involve the participation of
human subjects. Compliance with this standard provides public assurance that the rights,
safety and well-being of trial subjects are protected, consistent with the principles that have
their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
The objective of this ICH GCP Guideline is to provide a unified standard for the European
Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical
databy the regulatory authorities in these jurisdictions. The guideline was developed with
consideration of the current good clinical practices of the European Union, Japan, and the
United States, as well as those of Australia, Canada, the Nordic countries and the World
Health Organization (WHO).
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.
The IRB/IEC should ensure that information regarding payment to subjects, including the
methods, amounts, and schedule of payment to trial subjects, is set forth in the written
informed consent form and any other written information to be provided to subjects. The
way payment will be prorated should be specified.
Investigator’s Qualifications and Agreements
The investigator(s) 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)
The investigator should be thoroughly familiar with the appropriate use of the
investigational product(s), as described in the protocol, in the current Investigator’s
Brochure, in the product information and in other information sources provided by the
sponsor.
The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements. The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period. The investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.