Clinical Research Seminars

Offered monthly over Zoom, Clinical Research Seminars provide a forum to discuss important ethical, regulatory, and operational research topics.  Seminars are designed for BU Medical Campus, BMC, BMC Brighton, BMC South and Boston HealthNet Community Health Centers staff. Registrations must be completed using an institutional email address, no personal email addresses will be accepted. 

All previous seminar recordings and slides are available in our Seminar Library. 

Registration for CRRO Seminars

Wednesday, October 21, 2026, 12:00-1:00pm  – Two Perspectives: FDA INDs, Exemptions, and Lessons Learned

Registration

Presenters:

  • Jean Liew, MD MS – Assistant Professor, Boston University Chobanian & Avedisian School of Medicine
  • Kelsey Goostrey, MPH – Research Program Manager, Boston University CTE Center

Skill Level: Skilled      JTF Competencies: 3, 4

Learning Objectives:

  • Identify when an FDA IND is needed and the steps required for the application process
  • Identify when an FDA IND exemption is appropriate and the information needed by the IRB and/or FDA to make a determination

Synopsis:

Navigating FDA regulatory requirements for investigational drugs can be complex. Join us as experienced researchers share their first-hand insights into the IND application and exemption processes. Through real-world case discussions, you’ll learn when an FDA IND is required, the essential steps for successful applications, and how to determine when an IND exemption is appropriate. Our presenters will also walk you through the critical information needed by the IRB and FDA to support these determinations. Whether you’re preparing your first submission or refining your institutional processes, this seminar offers practical guidance grounded in proven experience.

Date Upcoming Seminar Information  Registration Link
11/18/2026 Participant Retention: Insights from the Framingham Heart Study
Natalie Butler – Regulatory Administrator, Maureen Valentino – Recruitment Manager, and Nicole Spartano, PhD – Asst Director of FHS Research Center		 November Registration
12/8/2026 You Be the IRB: Case Studies in Human Research Protection
Matt Ogrodnik, MS, CIP-  OHRA Director		 December  Registration

 

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Questions about any of the above information? Contact us!

Suggestions for future seminars are always welcome and can be submitted by completing our Training and Education Recommendation Form. 

This seminar series is supported by the Clinical Translational Science Institute and the Office of Human Research Affairs.