Clinical site 2193493 204549829 2008-04-09T21:48:29Z Joeerato 6324194 /* External links */ 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]] [[Good clinical practice|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 == * [[International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use]] (ICH) * [[Clinical trial]] * [[Drug development]] * [[Data Monitoring Committees]] * [[Food and Drug Administration]] (FDA) * [[European Medicines Agency]] (EMEA) * [[Japan Ministry of Health]] * [[European Forum for Good Clinical Practice]] (EFGCP) == External links == *[https://www.ctnbestpractices.org/sites Clinical Site Resources] (Clinical Trials Networks, Best Practices: NIH Roadmap) *[https://www.ctnbestpractices.org/sites/siteoperations/ Site Operations] (NIH) *[http://www.spauldingclinical.com Spaulding Clinical] [[Category:pharmacology]] [[Category:clinical research]] [[ru:Специалист по клиническим исследованиям]] {{pharma-stub}}