Study Set-Up

Main Content

Site Initiation


  • Site initiation is the final step in the study set-up process. Site initiation occurs prior to site activation. Typically, the sponsor or clinical research organization will conduct a site initiation visit after the Institutional Review Board approves the clinical research study at that site and the clinical research study agreement is signed. This visit serves to train staff on the protocol and confirm that the site is ready to implement the clinical research study.


  • Prior to the site initiation visit, the site's clinical research study team should:
    • Familiarize themselves with the protocol and consent documents;
    • Finalize the case report form and data collection process; and
    • Prepare standard operating procedures for the clinical research study.