Tool For Success

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.

 

Protocol Deviation Log Template 

The Protocol Deviation Log provides participant-specific documentation of missed visits and other actions that deviate from the protocol.

Delegation of Authority Log

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.

Adverse Event Log

The Adverse Event Log provides a template for a study form for collecting information about adverse events that are reviewed by safety monitoring bodies.

Concomitant Medication Log

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.

Training Log Template

The Training Log provides a template to log all study staff training throughout the duration of the trial.

Note to File Archive Address Template

Notes to File Guidance

 

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.

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.