Clinical Trials 1.pptVIP

* * * UCSF SOM Sponsored Projects Policy on Research Related Patient Care Costs goes with first bullet. * * * * * * * * * * * * * * * * * * * Clinical Trials 1 Darlene Kitterman, MBA, Director, Investigator Support Integration Services (ISIS), Oregon Clinical Translational Research Institute (OCTRI) Audience This course is intended for “department administrative staff”—including clinical research coordinators, department administrators, division managers, department fiscal managers, department effort coordinators, etc. Introduction This course follows the financial life cycle of a clinical trial up to clinical trial implementation: Policies and guidance Budget preparation Payment schedules Set-up of Accounts Third party payer approvals What is a Clinical Trial at OHSU? Clinical Drug/Device Investigation Mission code 54 A study of a drug (device, or diagnostic) where it “…is administered or dispensed to, or used involving, one or more human subjects.” and is a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about erventions (drugs,... devices, or new ways of using known drugs...or devices).” Translation: A drug or device intervention into a person Clinical Trial FinancialPolicies and Guidance Research Study Rate Request, Account(s) Setup And Billing Of Clinical Services (ADM 05.17) Charges For Research Support (ADM 2.17) Use of Devices in Patients and Research Subjects (ADM 05.18) Sponsored Projects Budgets and Cost Coverage (No. 04-40-020) ORIO Enrollment Incentive Policy Research Documentation in the Integrated Health Record (HC-CLN-IHR-P005) Clinical Trial Financial Tools OHSU Hospitals and Clinics Research Rates, Accounts, Registration, Admission, and Charging Processes and FormsWebpage: /research/rates/index.shtml Clinical Trial Budget Templates Industry: /research/rates/budget_template.xls Federal: /research/rates/federalbudget.xls Clinical Trial Budget Checklist: /research/crp/