Study Title: HSR or UVA Study Tracking # Pharmacist Reviewer: Principal Investigator: Study Contact: Study Coordinator/Subinvestigator: Type of Review: New protocol IRB Meeting Date: Investigational intervention: MOA: Please select all that apply Oral Drug Infused drug if infused, please select: Chemo Non-hazardous (ex: most monoclonal – antibodies) Vaccine Is this considered gene therapy or biohazardous*? Yes No Phase of Study: Pilot Phase I Phase I/II Phase II Phase II/III Phase III Phase IV/Post-market Expanded Access (comp. use) Emergency Use Primary Objective: Considerations Inclusion/Exclusion Yes No Comments: NA Appropriate (addresses any pertinent contraindications pertaining to labs, prohibited medications, vaccinations, etc) Stopping parameters and Yes No Comments: plan for discontinuation NA clear Drug dosing rationale is Yes No supported by study NA Comments: documents or available drug info If placebo-controlled, Yes No Comments: placebo use is warranted NA (i.e. true equipoise; no standard of care for a comparator)
Study Title: HSR or UVA Study Tracking # Pharmacist Reviewer: Principal Investigator: Study Contact: Study Coordinator/Subinvestigator: Type of Review: New protocol IRB Meeting Date: Investigational intervention: MOA: Please select all that apply Oral Drug Infused drug – if infused, please select: Chemo Non-hazardous (ex: most monoclonal antibodies) Vaccine Is this considered gene therapy or biohazardous*? Yes No Phase of Study: Pilot Phase I Phase I/II Phase II Phase II/III Phase III Phase IV/Post-market Expanded Access (comp. use) Emergency Use Primary Objective: Considerations Inclusion/Exclusion Appropriate (addresses any pertinent contraindications pertaining to labs, prohibited medications, vaccinations, etc) Yes No NA Comments: Stopping parameters and plan for discontinuation clear Yes No NA Comments: Drug dosing rationale is supported by study documents or available drug info Yes No NA Comments: If placebo-controlled, placebo use is warranted (i.e. true equipoise; no standard of care for a comparator) Yes No NA Comments:
Investigational_Drug_Service_Review_Checklist-New_Protocol.docx