Moderator: Brent Collinsworth IRB Education & Outreach Specialist

Slides:

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Presentation transcript:

Moderator: Brent Collinsworth IRB Education & Outreach Specialist 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 (P&T Liaison to IRB-01)

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

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

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

Questions?

Thank you!