Investigational Drug Service at UC Davis Medical Center Description of Investigational Drug Service Fees Central IDS Pharmacy at UC Davis Health System Investigational Drug Pharmacy, Rm 1107 2315 Stockton Blvd Sacramento, CA 95817 IDS@ucdmc.ucdavis.edu Phone: (916) 703-4093 Fax:(916) 703-7048 Cancer Center IDS Pharmacy UC Davis Comprehensive Cancer Center Investigational Drug Pharmacy 4501 X Street, Rm 1008A Sacramento, CA 95817 IDSCC@ucdmc.ucdavis.edu Phone: (916)734-7176 Fax:(916) 734-2260 NOTE: This information is provided for reference only. This information is NOT to be used by researchers to determine the actual IDS fee charges associated with a specific protocol or proposed study. Actual estimates of UCDMC IDS fees will be outlined in a formal, written estimate provided to the research team by the IDS staff. IDS estimates are based on specific information provided in the protocol, investigator brochure and/or the sponsor-provided pharmacy manual. Protocol Set-up and First Year Inventory (Standard and Oncology/Cancer Center Trials) One time, non-refundable fee charged upon pharmacy study activation. Set-up fees include but are not limited to protocol review, site qualification visits, site initiation visits, development of study specific dispensing procedures, EMR entry and label design (mandatory), randomization (if needed) provision of GCP-compliant storage and inventory system including temperature monitoring, IXRS training/set-up, study drug supply security, creation of pre-printed prescription/order template, quarterly monitoring visits, first year study drug inventory, in-service training for essential pharmacy personnel, and drug destruction. Base Protocol Set-up $2000 Cryogenic Liquid Storage Fee $250 Additional, non-standard Pharmacy Personnel Training $100/hour 24 Hour and/or 7 days per week $250 Protocol Set-up—UCDMC Investigator Initiated Trials $1500 The Protocol Set-up fee for UCDMC Investigator Initiated Trials applies to UCDMC PI initiated studies only. This fee requires approval by an Investigational Drug Service Pharmacy Staff Pharmacist. Set-up fees include but are not limited services detailed above in Protocol Set-up fees for Standard and Oncology/Cancer Center Trials. Annual Maintenance Fee (Standard and Oncology/Cancer Center Trials) Annual maintenance and inventory fees will be applied to multi-year studies on the anniversary of the pharmacy study activation date. The Annual Maintenance Fee covers but is not limited to a monthly study drug inventory by IDS, study drug accountability, receipt and disposition, scheduled quarterly monitoring visits, temperature monitoring, and query responses. Base Annual Inventory Fee $1000 Cryogenic Liquid Storage/Monitoring Fee $250 UCDMC IDS Fee Description 09.29.15 Page 1 of 2 Annual Maintenance Fee—UCDMC Investigator Initiated Trials $500 The Annual Maintenance fee for UCDMC Investigator Initiated Trials applies to UCDMC PI initiated studies only. Annual maintenance and inventory fees will be applied to multi-year studies on the anniversary of the pharmacy study activation date. This fee requires approval by an Investigational Drug Service Pharmacy Staff Pharmacist. Annual Maintenance fees include but are not limited to services detailed above in Annual Maintenance Fees for Standard and Oncology/Cancer Center Trials. Study Close Out Fee (Standard and Oncology/Cancer Center Trials) $250 Study closure activities include but are not limited to return or destruction of study drug, archiving of study documents, final drug accountability and drug destruction (if needed), provision of outstanding documentation such as temperature monitoring logs, accountability logs, final billing if outstanding balance remains, and storage of protocol specific documents. Study Close Out Fee—UCDMC Investigator Initiated Trials $100 Study closure activities include but are not limited to return or destruction of study drug, archiving of study documents, final drug accountability and drug destruction (if needed), provision of outstanding documentation such as temperature monitoring logs, accountability logs, final billing if outstanding balance remains, and storage of protocol specific documents. Dispensing Fees $25-250/dispense Dispensing fees will be charged based upon protocol specific study drug dispensing requirements and drug handling and preparation requirements. Dispensing fees will vary based on the complexity of the preparation (e.g. simple dispense, compounded product, sterile compound, hazardous drug). Dispensing fees are charged for each prescription number generated. The estimate fee will be calculated based upon maximum chargeable cost per patient per pharmacy visit. Amount charged may be lower than estimated cost depending on actual prescribed dosage. UCDMC Investigator Initiated Trials will not be charged dispensing fees. Additional charges for shipping will apply beyond dispensing fees. IDS Fee estimates are subject to change upon further review of study materials if necessary. Pharmacy activity will not commence until signed agreement and required study documents are received by IDS by the research team. UCDMC IDS Fee Description 09.29.15 Page 2 of 2