What Is A Site Initiation Visit In Clinical Research?

Dan Sfera

An SIV or Site Initiation Visit is a monitoring visit that takes place after the Site Selection Visit. It is a visit that happens after the study sponsor has already selected the site for participating in a clinical trial.
During the SIV, the CRA (Clinical Research Associate) will make sure that the site is ready to actually start enrolling subjects in the clinical trial. The CRA makes sure that the site has all the passwords and appropriate study staff have access to the various vendor and portal platforms which will be used during the course of the study. They make sure that the appropriate study personnel have access to the EDC systems, access to the ECG machines and the ability to transmit the ECG by fax to the central ECG reader.
The CRA also checks to ensure that the IP(investigational product) is on site. They also confirm that all the source documents and regulatory documents are completed. In addition, the CRA checks for 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 matters.