A clinical site is a medical facility staffed with a clinical investigator (MD) and qualified for performing clinical research. To be qualified as a clinical site, strict regulations are to be adhered to. The foundations for these regulations are defined by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and regulatory authorities, which set the guidelines for good clinical practice (GCP) at clinical sites.
Per ICH GCP 4.1.1 the investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the clinical 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, the institutional review board/independent ethics committee (IRB/IEC), and/or the regulatory authority(ies).
Per ICH GCP 4.1.2 the investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the clinical protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor.
Per ICH GCP 4.1.3 the investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements. Per ICH GCP 4.1.4 the investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies). Per ICH GCP 4.1.5 the investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.
* Food and Drug Administration (FDA)