My Doctor Duties in Clinical Trials

The FDA has stressed the critical importance of adequate supervision and monitoring in clinical trials to ensure they are conducted properly. A key figure responsible for this oversight is the Principal Investigator (PI), as outlined in 21 CFR 32.6. The PI must ensure the trial follows the protocol and all applicable regulations, and that the rights, safety, and welfare of the trial participants are protected, including obtaining informed consent.

Consistently, the FDA has raised concerns about two major areas:
1. Drug Control: Investigators are required to maintain control and proper documentation of the drugs being used in the trial. A recurring issue is the failure to track where the drugs go.
2. FDA Form 1572 Compliance: Investigators must personally certify compliance with all requirements, supervise all aspects of the study, and take responsibility for participant safety. However, problems often arise with the form being incomplete, unsigned, or improperly submitted.

For assistance with clinical trial compliance, reach out to the Kulkarni Law Firm.

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Disclaimers:
This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. Listening to this video or otherwise depending on discussions in this video do not, in any way, create an attorney attorney-client relationship