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
Banner Research Revenue
Audit Readiness
- Blanca Pernic, Officer, Research-Quality Assurance, University of Arizona
Email: bpernic@email.arizona.edu
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
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
- BUMCT Chemistry Reference Ranges
- BUMCT Hematology Reference Ranges
Banner University Medical Center - South Campus
- CLIA Certificate
- CAP Certificate
- Medical Director License
- Medical Director CV
- BUMCT Chemistry Reference Ranges
- BUMCT Hematology Reference Ranges
Banner University Medical Center- North Campus
- CLIA Certificate
- CAP Certificate
- Medical Director License
- Medical Director CV
- BUMC North-OG Chemistry Reference Ranges
- BUMC North-OG Hematology Reference Ranges
Banner University Medical Center- Orange Grove