Clinical Trial Site Visits
The ability of a sponsor of a clinical trial to conduct a site visit depends upon who authored the protocol – the Sponsor or the Principal Investigator (PI). A clinical trial where the protocol is written by the Sponsor is referred to as a Sponsor-Initiated Clinical Trial. A clinical trial where the PI is the author of the protocol is referred to as a PI-Initiated Clinical Trial.
Sponsor-Initiated Clinical Trials
Under Sponsor-Initiated Clinical Trials, the sponsor or its authorized representative will be entitled to examine, at mutually agreeable times during normal business hours, the facilities where the clinical trial is being conducted, the trial data, and other relevant information necessary to confirm that the trial is being conducted in accordance with the terms of the clinical trial agreement, the protocol, and applicable laws and FDA regulations. A Sponsor or its representative that is provided access to source records for the purpose of monitoring or auditing the clinical trial cannot make a record of or disclose direct identifiers of any participating patient in the trial (including the patient’s name, street address, telephone, social security, medical record, or health plan beneficiary numbers). In the event that copies of the original source records are to be made, all direct identifiers of patients participating in the clinical trial must be redacted prior to copying or taking copies of the source documents off site.
PI-Initiated Clinical Trials
Under PI-Initiated Clinical Trials, the Institution and Principal Investigator are solely responsible for the monitoring of the clinical trial in compliance with good clinical practices. Visits by the sponsor shall be limited to the review of clinical data for the sole purpose of pursuing regulatory filings related to the study drug or device. The review of such data cannot contain patient identifiers.