FDA Regulatory Control of the Drug Development Process and Investigator Responsibility in the
When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator
(for IDE studies), she / he is signing a legally binding document committing themselves to
follow all of the appropriate regulations. In the FDA form 1572, the Investigator signs an
agreement that has 9 statements, 7 of which begi n with "I agree".
Named in the 1572 is 21 CFR 50 (Protection of Human Subjects), 21 CFR 56 (Institutional
Review Boards), and 21 CFR 312 (Investigational New Drug Application / IND). For Device
studies, 21 CFR 812 (Investigational Device Exemptions / IDE) is added in place of 21 CFR 312.
Additional responsibilities are clearly outlined in the Compliance Program Guidance Manual
(CPGM) 7348.811. To follow the regulations is Good Clinical Practices (GCP) and common
sense. To not know and follow these regulations is folly.
As codified in 21 CFR 312.64(b), an investigator shall promptly report to the sponsor any
adverse event that may reasonably be regarded as caused by, or probably caused by, the drug. In
this Webinar, learn how well-controlled and well-conducted clinical trials that follow the Code
of Federal Regulations and the Principles of GCP are important to both sponsors and CRO's /
investigator sites. See how compliance with the Regs and Good Clinical Practice will ensure
quality data, speed up the review process, and decreases the costs.
Why Should you Attend:
There is an increasing frequency of real-time FDA Audits of trials and it seems that no one is
well prepared. It is the obligation of the major players in the drug development process (the
Investigator and the study Sponsor) to be sure studies are carried out correctly so that errors and
mistakes are found and corrected by them (CAPA) and not by an FDA Investigator.
Objectives of the Presentation:
The Investigators role in the clinical research process, the IC process, ...
Know how the Regs define the many terms describing Adverse Events
Why the investigator files the signed and dated protocol?
What is the legal language of the FDA form 1572 or Device equivalent?
Why is Financial Disclosure information important?
What is the history of the drug / device regulations?
Who can Benefit:
Those benefiting the most would be the Principal Investigators and sub investigators, Clinical
Research Scientists (PKs, Biostatisticians, ...), Safety Nurses, Clinical Research Associates
(CRAs) and Coordinators (CRCs), Recruiting staff, QA / QC auditors and staff, & Clinical
Research Data managers In addition, the holders of the IND for new products i.e. the Sponsors