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CLINICAL RESEARCH IMPLEMENTATION COMMITTEE – OPERATIONAL ASSESSMENT CHECKLIST Purpose: the purpose of this checklist is to help facilitate the committee’s goal of reviewing logistics of each potential trial early in the activation process, to help identify potential challenges and mitigate them prior to trial activation at UVA. Section 1.0: General Study Questions Title: PI: Study Coordinator: Study Team: Phase of Study ☐Pilot ☐Phase I ☐ Phase I/II ☐ Phase III ☐Phase IV Number of patients expected to enroll over study duration? ☐1-4 ☐ 5-10 ☐10-15 ☐15+ Section 2.0: Investigational Product Information & Pharmacy Logistics Are the investigational agent(s) involved in this study FDA-approved? How will the drug(s) be provided? How would you describe the ‘type’ of drug product in this study? Any special equipment necessary? This could include compounding equipment, administration equipment such as tubing/pumps, or special fluids. ☐Yes ☐No ☐By the sponsor ☐Commercially available – IDS to purchase on sponsor’s behalf ☐Commercially available – patient’s insurance to pay Please select all that apply: ☐Oral Drug ☐Infused drug – if infused, please select: ☐ Chemo ☐ Non-hazardous (ex: most monoclonal antibodies) ☐Vaccine – If vaccine, is this considered gene therapy*? ☐Yes ☐No *if genetic material is involved, will require biosafety plan ☐Yes* ☐No ☐Don’t Know – need pharmacy manual *If Yes, will the sponsor be providing? ☐ Yes ☐No Comments: ______________________________________________ Is there a pharmacy manual? How will the drug(s) be administered? ☐Yes* ☐ No *If yes, please send to IDS pharmacy Section 3.0: Drug Administration Logistics ☐IV infusion ☐ID/SC/IM injection Please select all that apply. ☐oral ☐other (topical, intranasal, etc.) Comments:_______________________________________________________________ Does the protocol require frequent monitoring during or after administration? ☐Yes (This may be every 15 minute vitals, ECG, etc) ☐No Are there research blood samples required? ☐Yes* ☐ No *If yes, how often?(please select as many as applicable) ☐1-2 hours post infusion ☐2-4 hours post infusion ☐4-12 hours post infusion ☐Outside normal business hours (8:15am – 4:30pm)? Comments:_______________________________________________________________ Comments:_______________________________________________________________ Version date: 10/1/2014 1 Are there restrictions to the days of the week patient can be treated in infusion? Does the protocol require patient isolation? ☐Yes* Do you anticipate needing to administer drug or monitor patient outside of normal business hours (8:15am – 4:30pm)? ☐Yes* ☐ No *If yes, please describe: _____________________________________________________ ☐Yes* ☐ No *If yes, please describe: _____________________________________________________ ☐ No *If yes, please describe: _____________________________________________________ Section 4.0: Lab Logistics & Collection Requirements Are there biopsies ☐Yes ☐ No required? Do you anticipate ☐Yes ☐ No using the BTRF? Do you anticipate ☐Yes ☐ No after-hours processing? Are there same-day ☐Yes ☐ No shipments or batch shipments required? Is there a lab manual ☐Yes ☐ No available? Additional Comments: _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ FINAL REVIEW OUTCOME (to be completed by the CRIC upon review of completed checklist): Where will the drug(s) be Please select all that apply: administered? ☐Infusion Center ☐Clinic ☐CRU ☐Inpatient ☐Home – self administered Will a treatment plan need to be built for this study? What is the estimated timeline to trial activation? ☐Yes ☐ No Based on acuity and checklist assessment, this trial will take approximately ____ weeks to open. Comments:____________________________________________________ Action Items and Additional Comments: _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ Version date: 10/1/2014 2