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The Quality Improvement Program (QIP) within UCLA?s Human Research Protection Program provides internal oversight and training to research investigators and their staff and the IRB with recommendations to improve the overall program of human subjects protections:
- Review of all post approval event reports, including but not limited to adverse events, protocol violations and/or incidents, subject complaints, and allegations of non-compliance.
- On-site reviews of studies that are more than minimal risk. Visits may be directed reviews requested by the IRB, a Department or Federal agency or in response to a subject or other complaint. On-site reviews may be selected as part of the ongoing monitoring of more than minimal risk studies.
- Assessment of adherence with federal, state, local regulations, Good Clinical Practices, UC/UCLA policies and guidelines.
- Assistance with questions about compliance with HIPAA requirements.
Please contact any of the people listed below if you need assistance or have questions.
| Name and Title |
Phone Number and E-mail Address |
Bette Okeya, PharmD, CIP
Assistant Director, Quality Improvement
(Post Approval Reporting: Adverse Events, Violations, Subject Complaints)
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bokeya@research.ucla.edu
310-206-2040
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Marcia Malmet, RN
Manager, Quality Improvement
(Questions about or requests for on-site reviews of studies or questions about HIPAA)
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mmalmet@research.ucla.edu
310-983-3150
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Sharon Friend, MS, CIP
OHRPP Director
(Policies, guidance or procedures as well as suggestions for improvement, complaints, concerns, or compliments.)
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sfriend@research.ucla.edu
310-825-5855
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Alisa Irwin, CIP
Assistant Director for Medical IRBs
(Matters related to the Medical IRBs.)
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airwin@research.ucla.edu
310-825-4849
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Alison Orkin, PharmD, CIP
Assistant Director, General Campus IRBs
(Matters related to the General Campus IRBs.)
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aorkin@research.ucla.edu
310-206-3969
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