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Secretary's Advisory Committee on Human Research Protections (SACHRP)
SACHRP December 2003 Meeting Presentations
- Welcome and Opening Remarks
Ernest D. Prentice, Ph.D.
Subcommittee Reports
- Subpart D Subcommittee - Report for SACHRP Consideration: The 45 CFR 46.407 Process
Celia B. Fisher, Ph.D.
- Accreditation Subcommittee Report
Felix A. Khin-Maung-Gyi, Co-Chairperson
International Research Issues Panel
- OHRP International Activities and Challenges
Melody Lin, Ph.D.
- Perspective from the Field - The Realities of Developing Country IRBs
David Borasky, C.I.P.
- Capacity-building in International Research: Challenges and Practices
Helen McGough, M.A.
Adverse Event Reporting Issues Panel #1
- Reporting Requirements for Adverse Events: An HHS Regulatory Perspective
Michael A. Carome, M.D.
- FDA's Adverse Event Reporting and Review
David A. Lepay, M.D., Ph.D.
- IRB Review of External Adverse Event Reports (AERs) - The City of Hope Model
John A. Zaia, M.D., Chair, IRB
- Wahington University School of Medicine IRB: Externally Occuring SAE Reports
Patricia Scannell, B.A., C.I.P.
Adverse Event Reporting Issues Panel #2
- Adverse Event Reporting: Drug Industry Perspective
Peter K. Honig, M.D., M.P.H.
- Adverse Event Reporting: A Device Manufacturer's Perspective
Barbara Westrum
- NIH Perspectives on Adverse Event Reporting: Looking to the Future
Amy Patterson, M.D.
- Clinical Trial Data Monitoring Committees: Roles, Practices, and Policies
Susan S. Ellenberg, Ph.D.
If you have questions about SACHRP, click sachrp@osophs.dhhs.gov
If you have questions/suggestions about this web
page, click lniemoeller@osophs.dhhs.gov
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