Research Conduct and Compliance
for Human Subject Research

Guidance Documents and Sample Forms

Guidance Documents

Good Research Practice Guidance (Word)

• Introduction
• Highlights of Good Research Practice for Psychosocial/Descriptive Studies
• Highlights of Good Research Practice for Medical/Interventional Studies

The International Conference of Harmonization - Good Clinical Practices (PDF)

FDA Guidance Documents

Office for Human Research Protections - Policy Guidance

Adverse Events / Unanticipated Problems Log

Concomitant Medications Form

Consent Form Chart

Data Safety and Monitoring Minutes Form

Eligibility Checklist

Generic Drug Account Form Sample (Excel)

Investigational Device Accountability Log

Informed Consent Process Documentation

Site Personnel Signatures, Training and Delegation of Duties Sample Log

Note to File Form - Option 1

Note to File Form - Option 2

Phone Communications Log

Phone Screening Sample Script

Phone Screening Form Template

Pre-Study Activities Checklist

Progress Note Form

Research Orientation Checklist

Screening Log

Tips for Developing Standard Operating Procedures

Visit Tracking Form - Version #1

Visit Tracking Form - Version #2