Moderator: Kelly O’Berry IRB Education & Outreach Manager

Slides:

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Presentation transcript:

Moderator: Kelly O’Berry IRB Education & Outreach Manager Human Research Protection Program (HRPP)Committees & Units Panel Discussion Moderator: Kelly O’Berry IRB Education & Outreach Manager

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

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

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

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

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)

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

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

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

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

Questions?

Thank you!