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, IRBs, and sponsors properly manage these responsibilities?

In this webinar, Dr. Constance Cullity (former FDA Supervisory Medical Officer and Branch Chief) joins Lauren Hartsmith (who previously served as an OHRP Policy Analyst) and Michele Russell-Einhorn, Advarra’s Chief Compliance Officer and IO, to discuss the basics of FDA and Common Rule reporting.

Find out about FDA reporting requirements for sponsors and investigators involved in IND studies, and get the scoop on Common Rule requirements for identifying, reviewing, and reporting unanticipated problems and noncompliance to IRBs and Common Rule departments or agencies.

Learning Objectives:

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

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