Conducting the Clinical Trial
Launching of the Clinical Trial
The clinical trial cannot commence until all regulatory compliance approvals are in place (e.g., IRB approval of the protocol, informed consent, and HIPAA Authorization form) and, thereafter, SPA has: (i) signed and is in receipt of a fully executed CTA and (ii) fully executed the clinical trial subcontract with the facility whose premise and/or clinical support services will be utilized. (Again, SPA may negotiate the CTA simultaneously with the IRB process; it is just that the contractual signature process must be delayed until all regulatory approvals are in place. Thereafter, the performance of the clinical trial may begin.)
Clinical Trial Site Visits
The ability of a sponsor of a clinical trial to conduct a site visit depends upon who authored the protocol (i.e., 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 an investigator-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 CTA, 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.
Investigator-Initiated Clinical Trials
Under investigator-initiated clinical trials, the Institution and PI 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.