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

5. 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)

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

7. 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

8. 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

9. 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

10. 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)

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

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

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

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

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

16. Questions?

17. Thank you!