Clinical Research

Must be submitted every three years or if contact information for the monitor or coordinator changes. Submit this form no sooner than one week prior to the day that monitor access will be needed.Monitors who do not have a signed and current UAHN System User Agreement must fill out and sign a new agreement. Ensure that at least one study IRB number is entered on the form, along with the dates that the monitor will be on-site. If the monitor is working on more than one study that requires access to records, we recommend that all of the study IRB numbers be included on the form. Fax the form to (520) 694-0222. The study coordinator can also check CARS (in Citrix) or contact the UAHN helpdesk (694-4357) to check if a monitor already has a signed and current UAHN System User Agreement.

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.

Outlines the position of the University of Arizona on Epic Electronic Health Record (EHR) compliance with FDA 21 CFR 11 requirements.

A template letter claiming exemption from the Arizona Board of Regents Intellectual Property Policy, based on meeting the criteria outlined here. Relevant to the clinical research contract review process.

This form is required as part of the clinical research contract review process when the contract type is a Material Transfer Agreement (MTA).

This policy is intended to protect medical student confidentiality and provides restrictions on requests for and use of College of Medicine – Tucson (COM-T) undergraduate Medical Education Data for research and program improvement purposes. Data requests must be submitted to and approved by the Accreditation & Analytics Office. Medical Education Data must be used in a manner that protects student confidentiality.