Initiation of an Investigator Site

Initiation of a trial site ensures that all required trial authorizations and documentation are in place and that the protocol and trial procedures are reviewed with the investigator and the investigator’s trial staff in accordance with the protocol, SOPs, GCP, and the applicable regulatory requirement(s).

Initiation is integral to the QC of a clinical trial and is designed to ensure quality of the trial according to Sponsor requirements and to ensure that all necessary documents are in place to facilitate conduct and ongoing documentation of the trial.

SOP: Initiation of an Investigator Site (.pdf 700Kb)

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