Safety and Regulatory Issues in Patient-Oriented Research
(webcasts and supplemental materials linked here)
Coordinator: Barbara A. Levey, MD, FACP
The goal of this module is to start the process of familiarizing trainees with the multiple steps of regulatory oversight in patient-oriented investigation, including the IRB, the FDA, Data Safety Monitoring Boards, and regulatory issues in clinical trials.
This module is composed of the following workshops:
1. Clinical Trial Contracts: the Pre-Award Roadmap
Helene Orescan, JD, Director, Clinical Trials Contract Unit, David Geffen School of Medicine at UCLA
Bishoy Anastasi, Supervisor, Clinical Research Administrator, Clinical Trials Contract Unit, David Geffen School of Medicine at UCLA
Tuesday, February 07, 2012 9:00 AM - 10:00 AM
2. Conducting Risk Assessments and Determining IRB Level of Review
Alisa Irwin, Assistant Director, Office of the Human Research Protection Program, UCLA
Leslie J. Raffel, MD, Professor of Pediatrics, Cedars-Sinai Medical Center
Tuesday, February 07, 2012 10:00 AM - 12:00 PM
3. Regulatory Issues in Gene Therapy
Antoni Ribas, MD, Professor of Medicine-Hemotology/Oncology, UCLA
Wednesday, February 08, 2012 9:00 AM - 10:00 AM
4. Regulatory Issues In Children and Genetics Clinical Protocol
James McGough, MD, Professor of Clinical Psychiatry, Chair of Medical Institutional Review Board, UCLA
Wednesday, February 08, 2012 10:00 AM - 11:00 PM
5. Data Monitoring: Assuring Safety and Study Integrity in Clinical Research
Laurie Shaker-Irwin, PhD MS, Assistant Professor of Medicine, Clinical and Translational Science Institute, David Geffen School of Medicine at UCLA
Wednesday, February 08, 2012 11:00 AM - 12:00 PM
