<back

Interpreting the FDA Guidances on Investigator Responsibility and Adverse Event Reporting to IRBs: Effective Adoption within Your Organization
March 29-31, 2010 
Washington DC  

The recent increase in FDA's compliance program and inspection activities are evident to the clinical investigator and all research practitioners. FDA has forewarned the research community of their expectations by publishing guidance documents to help interpret the existing regulations. Two recent guidance documents provide additional clarification of investigator responsibilities (Guidance for Industry: Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects, October 2009) and adverse event reporting responsibilities (Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs -Improving Human Subject Protection, January 2009). This session addresses the conference participants' experiences with implementation of these two documents. Its objectives are to:

• Explain the FDA's expectations of the clinical investigator's (CI) responsibilities
• Describe what may or may not be delegated by the CI to another individual
• Determine if an adverse event is an unanticipated problem and if it need to be reported
• Describe which events need to be reported to the IRB

Moderator
Felix Khin-Maung-Gyi, PharmD, MBA, CIP, RAC
CEO, Chesapeake IRB

Panelists
Christine Pierre, President, RxTrials
Katie Driscoll Alberta, Senior Director WWQA GCP & GPvP, Cehpalon, Inc.