Documentation Tools

The ECS-HSR staff has developed templates that may be used to document most study activities. These templates serve as examples of GCP compliant data collection forms and may be edited for specific study procedures.

University of Pittsburgh Guideline: Study Documentation for FDA Regulated Research and Clinical Trials
Adverse Events Log
Adverse Events (Serious Adverse Event) Report Form
Concomitant Medications Form
Consent Form Chart
Data Safety and Monitoring Minutes Form
Eligibility Checklist
FDA Inspection - Checklist
FDA Inspection - Helpful Hints
Generic Drug Account Form Sample (Excel)
Investigational Device Accountability Log
Informed Consent Process Documentation
Site Personnel Signatures, Training and Delegation of Duties Sample Log
Monitoring Checklist
Noncompliance / Deviations Log
Phone Screening Log
Progress Note Form
Study Communication Log
Visit Tracking Form—Version #1
Visit Tracking Form—Version #2