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Human Research Protection Program (HRPP)Committees & Units Panel Discussion

Human Research Protection Program (HRPP)Committees & Units Panel Discussion. Moderator: Brent Collinsworth IRB Education & Outreach Specialist. Pharmacy & Therapeutics Sub-Committee (P&T). Contact for P & T: Ron Herman, PhD Clinical Pharmacy Specialist Department of Pharmaceutical Care

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Human Research Protection Program (HRPP)Committees & Units Panel Discussion

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  1. Human Research Protection Program (HRPP)Committees & UnitsPanel Discussion Moderator: Brent Collinsworth IRB Education & Outreach Specialist

  2. Pharmacy & Therapeutics Sub-Committee (P&T) Contact for P & T: Ron Herman, PhD Clinical Pharmacy Specialist Department of Pharmaceutical Care (P&T Liaison to IRB-01)

  3. Pharmacy & Therapeutics Sub-Committee (P&T) Speaking: Debra O’Connell-Moore Research Coordinator ICTS

  4. P&T Committee – Safety Review • Safety review for all studies that involve investigational medications • Review is independent from Investigational Drug Service (IDS) that reviews: • Proper storage • Dispensation • Management of study medications

  5. Safety review – AreaS of Focus • P&T Reviews: • Study Protocol • Investigator Brochure • G-12 (P&T Application Form) • Risks to subjects • Risks – must inform subjects • Describe in HawkIRB (Section VIII) • Describe in Informed Consent

  6. Safety Review – AreaS of Focus (cont.) • G-12 Form – properly completed, available for healthcare providers • Only for meds without FDA approval for marketing or tested for a different dose, indication or route of administration • Synthesizes information from Investigational Drug Brochure • Automatically uploaded into the medical record for all enrolled subjects – when the medication is ordered in EPIC

  7. P&T Goals • Warn subjects of risks of study drugs and ancillary medications • Inform subjects about other treatment options • Provide basic information for healthcare workers caring for research subjects - about study medication, may not be in current resources such as Micromedex (in the G-12)

  8. Medical Radiation Protection Committee (MRPC) Joe Graves, MS Assistant Director, Radiation Safety Officer

  9. Protocol Review and Monitoring Committee (PRMC) Angela Childs Protocol Management, HCCC

  10. Nursing Research Committee (NRC) Kirsten Hanrahan, DNP, ARNP Interim Director, Nursing Research, Evidence-Based Practice and Quality

  11. Investigational Drug Service (IDS) Contact: Theresa Hobbs Kristine Johnson Wendi Slaughter Melissa Jones

  12. Investigational Drug Study Standard Charge Worksheet • Drug Study Form 75A ***Attach any manuals or forms that pertain to the preparation of the medication

  13. Questions?

  14. Thank you!

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