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Clinical Trial Principal Investigator Duties in Clinical Trials
Manage episode 452102742 series 3506216
محتوای ارائه شده توسط Darshan Kulkarni. تمام محتوای پادکست شامل قسمت‌ها، گرافیک‌ها و توضیحات پادکست مستقیماً توسط Darshan Kulkarni یا شریک پلتفرم پادکست آن‌ها آپلود و ارائه می‌شوند. اگر فکر می‌کنید شخصی بدون اجازه شما از اثر دارای حق نسخه‌برداری شما استفاده می‌کند، می‌توانید روندی که در اینجا شرح داده شده است را دنبال کنید.https://fa.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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