The purpose of the Coordinator Corner Toolbox is to provide a Web-based information repository for investigators and staff involved in clinical research. The Toolbox contains templates, sample forms, and information materials to assist investigators in the development and conduct of high-quality clinical research studies.
Regulatory
- WCG IRB Connexus Slides
- eIRB Presentation
- What do Expect from an FDA Audit
- Preparing for FDA Audit Handout
UAHS Research Administration
- Payer Coverage Analysis Slides
- Oncore Refresher
- Research Administration (RIA) Intake Application
- CMS Coverage Decisions and Clinical Quality Slides
Banner Research Revenue
Requesting Banner Data 2021
Audit Readiness
- Blanca Pernic, Officer, Research-Quality Assurance, University of Arizona
Email: bpernic@email.arizona.edu
Banner Auditing
- Pamela Kinder, Research Compliance Analyst, Banner Health
Email: Pamela.Kinda@bannerhealth.com
Files
Clinical Trial Audits - What is Being Checked
Protocol Deviation Log Template
The Protocol Deviation Log provides participant-specific documentation of missed visits and other actions that deviate from the protocol.
The Site Signature Log - Delegation of Authority Log is a record of all study personnel and their specific responsibilities, signatures, and dates of involvement during the conduct of a clinical research study.
The Adverse Event Log provides a template for a study form for collecting information about adverse events that are reviewed by safety monitoring bodies.
The Prior and Concomitant Medications Log provides a template to log prescription and over-the-counter drugs and supplements a study participant has taken along with the study intervention.
The Training Log provides a template to log all study staff training throughout the duration of the trial.
Note to File Archive Address Template
Please use this link to open our Standard Operating Procedure page. Note that you will need to use your netid to authenticate to the page.
*Notice: CAP Certificates for Banner & Sonora Quest Facilities are currently pending. The labs were inspected on March 18, 2024 and will provide updated certificates as soon as they are available. Once received the website will be updated. Thank you for your patience.
CATS
Sonora Quest Laboratories
- CLIA Certificate
- CAP Certificate*
- Medical Director License
- Medical Director CV
- Reference Range Summary
- Stat Lab Orders Process
Banner University Medical Center - Main Campus
- CLIA Certificate
- CAP Certificate*
- Medical Director License
- Medical Director CV
- Reference Ranges Summary
- BUCCNOG to Reference Ranges BUMC-T North
Banner University Medical Center - South Campus
- CLIA Certificate
- CAP Certificate*
- Medical Director License
- Medical Director CV
- BUMCS to Reference Ranges BUMC-T South
Banner University Medical Center- North Campus
- CLIA Certificate
- CAP Certificate*
- Medical Director License
- Medical Director CV
REDCap
REDCap (Research Electronic Data Capture) is a secure, Web-based application designed to support data capture and storage for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. REDCap has been designed to allow for compliance with such standards as HIPAA, 21 CFR Part 11, FISMA (low, moderate, high), and international standards.
Statistics and Consulting Lab
The Stat Lab is available to collaborate with scientists and physicians across the University.