This worksheet in Excel format will help you calculate start-up costs for a clinical trial/study at the College of Medicine - Tucson. Also includes a completed example budget on Sheet 2.
Template worksheet and sample budget for industry-sponsored clinical trials. Useful for budgeting clinical trials/studies.
The Schema Review Memo, along with the reviewed protocol schema, is required prior to Banner and UA IRB review. The Memo provides documentation of the schema review process by the Principal Investigator and the Epic Charge Validator. If there is no Charge Validator because the study will not utilize Banner services, the Study Coordinator information should be provided instead. A blank Schema Review Memo is provided in this link along with three examples of reviewed protocol schemas.
Retrospective Chart Review projects using HSPP Form F203 do not require submission of this document.
Instructions:
1) Complete the Memo, including the required signatures.
2) Follow the instructions on the Memo to review the Protocol Schema, Schedule of Events, or Calendar of Events. If a schema is not included in your protocol, create a list of the research events in a Word document. Include a statement, "All circled protocol events are research-related and not part of routine care."
3) Circle services that are research-related and not considered routine care (standard of care).
4) The PI and the Epic Charge Validator must print their names, sign, and date the reviewed Schema or Calendar of Events.
4) Upload the Memo and reviewed Schema to the online submission form.
Lists typical pharmacy fees associated with clinical trials/studies, and includes contact information for studies at various UAMC locations.
A list of common personnel costs for clinical studies/trials. Useful for estimating time and effort on specific tasks when constructing a clinical trial/study budget.
A list of invoiceable items for clinical trials/studies. Useful for clinical study budgeting.
A policy memo stating the circumstances in which indirect cost (F&A) waivers may be granted, and the process for requesting such a waiver.
Guidelines designed to assist Principal Investigators in identifying the appropriate indirect cost (F&A) rate for their research.
Use this form to request funding for research equipment. The equipment may be part of a new or existing Core/Shared Service.
A policy memo specifying the indirect cost (IDC) rate for clinical studies performed on campus.