Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

Videos

Got Questions on Regulatory Issues?

How IRB reliance can help fast forward your multisite study

Informational Videos for Individuals Considering Research Participation

Donating Your Tissue for Research presented by the National Cancer Institute

Considering the Research Subject's Perspective - for Investigators & Study Staff

Submitting Results to ClinicalTrials.gov

Data Safety Monitoring Boards

So you've said yes, now what? Sitting on, or chairing, a Data Safety Monitoring Board

NIH DSMB Charters

Safety

Introduction

Overview of Multi-Regional Clinical Trials

DSMBs role in Multi-Regional Clinical Trials (Case study)

DSMB Dilemmas in international trials: a case study

Considerations for decision makers - beyond stopping boundaries

Multiregional clinical trials - how DMCs look at interim data


Investigator IND/IDE Education Symposium

Elizabeth Hohmann, MD, IRB Representative and IND Holder
Chair and Physician Director, Partners Human Research Committee, Partners Healthcare

Nazem Atassi, MD, MMSc, IND Holder
Associate Director, Neurological Clinical Research Institute (NCRI), Massachusetts General Hospital

Alexa Kimball, MD, MPH, IND Holder
Associate Professor, Harvard Medical School
Senior V.P. for Practice Improvement, Massachusetts General Physician Organization

Leigh R. Hochberg, MD, PhD, FAAN, IDE Holder
Senior Lecturer, Neurology, Massachusetts General Hospital

Panel Discussion moderated by: Sarah White, MPH, CIP, RAC, Director, Human Research Quality Improvement Program (QI Program), Partners Healthcare

Topics include: IRB assistance & the IRB's role, FDA submission/working with the FDA, dealing with intellectual property, sponsor-investigator monitoring responsibilities, non-traditional INDs, and additional resources required to conduct a sponsor-investigator initiated research study

Audience Question/Answer Session:

Watch the full symposium: