Clear drug modifications Yes No Comments: are included in the NA protocol Adequate toxicity/side Yes No Most common toxicities: effect information is NA available and guidance for management available Concomitant medications Yes No Comments: NA and potential drug interactions are addressed How the study drug is Yes No How supplied: supplied is detailed NA By the sponsor Commercially available IDS to purchase – on sponsor’s behalf Commercially available patient’s – insurance to pay Comments: How the study drug is Yes No Comments: compounded/administered NA is detailed How drug intervention is Yes No Comments: described in consent is NA accurate and clearly defines what is research and what is standard of care of study medications Yes No Comments: are accurate and NA comprehensive based on available drug information and study docs (Lexi-Comp, Micromedex, protocol, IB) Forms Comments/Issues Protocol IB Consent Form/Lay Language
Clear drug modifications are included in the protocol Yes No NA Comments: Adequate toxicity/side effect information is available and guidance for management available Yes No NA Most common toxicities: Concomitant medications and potential drug interactions are addressed Yes No NA Comments: How the study drug is supplied is detailed Yes No NA How supplied: By the sponsor Commercially available – IDS to purchase on sponsor’s behalf Commercially available – patient’s insurance to pay Comments: How the study drug is compounded/administered is detailed Yes No NA Comments: How drug intervention is described in consent is accurate and clearly defines what is research and what is standard of care Yes No NA Comments: of study medications are accurate and comprehensive based on available drug information and study docs (Lexi-Comp, Micromedex, protocol, IB) Yes No NA Comments: Forms Comments/Issues Protocol IB Consent Form/Lay Language
Investigational_Drug_Service_Review_Checklist-New_Protocol.docx