Study Files Management

The documents below contain reference guides, checklists and other forms to assist in the record keeping and data management of FDA-regulated and non-FDA-regulated research. These reference documents come to Yale as the result of an ARRA-funded collaboration between YCCI and the Mayo Clinic Center for Translational Science Activities, which is designed to help support and reduce the regulatory and reporting burden on investigators through the sharing of effective practices between institutions.

Quick Reference Guide
for FDA-Regulated Research

Quick Reference Guide
for Non-FDA Regulated Research

Checklists for FDA-Regulated Research

Checklists for Non-FDA-Regulated Research

Clinical Research
Training Log

Monitoring Log

Signature and Delegation of Responsibility Log