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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.
- 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
Senior Director, Regulatory Compliance
Lauren A.J. Hartsmith
Director, Regulatory Affairs
Chief Compliance Officer and Institutional Official
Who should watch?
This content applies to HRPP/IRB directors; principal investigators; sponsors and sponsor-investigators; regulatory affairs representatives; research operations personnel; and others involved in research reporting from sponsors, CROs, and investigative sites.
Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations and 1 hour of continuing education credit for the Certified IRB Professional (CIP) certification.
Provider approved by the California Board of Registered Nursing, Provider Number 16549, for 1 contact hour. This documentation must be retained by the licensee for a period of 4 years after the course concludes.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.
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Certificate of Attendance
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DATE: July 8, 2020
Time: 1 pm ET | 10 am PT
Duration: 1 hour