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Clinical Trial Principal Investigator Duties in Clinical Trials
Manage episode 452102742 series 3506216
Το περιεχόμενο παρέχεται από το Darshan Kulkarni. Όλο το περιεχόμενο podcast, συμπεριλαμβανομένων των επεισοδίων, των γραφικών και των περιγραφών podcast, μεταφορτώνεται και παρέχεται απευθείας από τον Darshan Kulkarni ή τον συνεργάτη της πλατφόρμας podcast. Εάν πιστεύετε ότι κάποιος χρησιμοποιεί το έργο σας που προστατεύεται από πνευματικά δικαιώματα χωρίς την άδειά σας, μπορείτε να ακολουθήσετε τη διαδικασία που περιγράφεται εδώ https://el.player.fm/legal.
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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