Site Initiation


Site initiation is the final step in the study process prior to site activation. Sponsor or Clinical research organization conduct the site initiation visit after the institutional Review Board approves the clinical research study at the site and the clinical research study agreement is signed. The visit serves to train staff on the protocol and confirm that the site is ready to implement the clinical research study. The monitor makes sure that the site has all the passwords and appropriate study staff have access to the various portal platforms which will be used during the course of the study. The monitor also checks to ensure that the IP (investigational product) is on site. Further, they confirm that all the source documents and regulatory documents are completed, informed consent documents and confirms that the site has IRB (Institutional Review Board) approval. Finally, the CRA checks for lab kits and essentially anything else that the site will need in order to start screening subjects for the trial, including answering the PI (principal investigator) questions on any protocol related.