The Must-Haves of FDA and Common Rule Reporting Requirements

The Food and Drug Administration (FDA) regulations governing investigational new drug (IND) applications contain specific reporting requirements. Similarly, the Common Rule (i.e., the federal policy for the protection of human subjects) also contains reporting requirements. Of course, the Common Rule and FDA reporting requirements differ.

It’s important to understand what must be reported to whom, and that everything is reported within the appropriate timeframe. How can investigators, institutions, institutional review boards (IRBs), and sponsors properly manage these responsibilities?

Join this webinar to hear the basics of FDA and Common Rule reporting from former FDA and Office for Human Research Protections (OHRP) professionals.

Learning Objectives:

• Summarize reporting requirements for institutions involved in research conducted or supported by Common Rule departments and agencies
• Outline FDA reporting requirements for sponsors of studies done under an IND application
• Explain FDA reporting requirements for clinical investigators who conduct IND studies
• Identify regulatory issues that could be subject to interpretation

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