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 V4.2 (.pdf 959KB)
Investigator and Site Initiation Visit Report v4 (1250KB)
Host Site Initiation Visit Checklist v4.0 (1282KB)
CI Site Initiation Visit Checklist v5.0 (1287KB)
Signature and Delegation Log v4 (1304KB)
