Clinical site

Clinical site is a medicalfacility staffed with a clinical investigator. As per ICH GCP4.1.1 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 vitaeand/or other relevant documentation requested by the sponsor, the institutional review board/independent ethics committee (IRB/IEC), and/or the regulatory authority(ies).

As 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.

As per ICH GCP 4.1.3 the investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements. As 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). As 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.

External links

• ICH Website

• FDA Websiteru:Специалист по клиническим исследованиям

This article is licensed under the GNU Free Documentation License.
It uses material from the http://en.wikipedia.org/wiki/Clinical+site Wikipedia article Clinical site.