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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. SEE ALSO
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