Tools and Guides

Researcher Tools

• Determination Regarding Not Human Subjects Research (NHSR)
• IRB Review of Quality Assurance/ Quality Improvement Projects
• When a PI Leaves UTHSC or Affiliate Institution
• IRB Review Process Map
• Study Procedures and Levels of IRB Review
• Submitting a New Application to the UTHSC IRB

Research/Project Checklists

• Consent/Assent Checklist
• Things to Remember When Conducting Human Subjects Research
• Exempt Project Checklist
• Expedited and Full Board Project Checklist
• Requesting Single Patient Expanded Access

Research Record Templates

• Research Protocol Template
• Consent Discussion Documentation
• Eligibility Checklist
• Screening/Enrollment Log
• Master Subject List (no consent)
• Visit Checklist
• Pay Documentation Template
• Adverse Event Tracking
• Delegation of Responsibilities
• Note-to-File

iMedRIS Guides

(UT NetID and password required)

• Investigator/Coordinator Getting Started Guide
• Routing, Workflow Tracking, and Signoff
• Guide to PI Response Form
• How to Submit a Form 2 - Change Request and Amendments
• How to Submit a Form 3 - Review Continuing Review (Renewal)
• CTSI: UTHSC Collection of First Informed Consent Date
• iMedRIS Correspondence
• Downtime

iMedRIS Video Guides

(UT NetID and password required)

• Video Guide - General (Beginner) IRB Training
• Video Guide - Advanced iMedRIS Training
• Video Guide - PI Response Form Submission
• Video Guide - Form 2 Change Request and Amendments
• CTSI: UTHSC Collection of First Informed Consent Date Video
• Watch short videos of iMedRIS version 11.02 revisions/additions (no sound)

Other Tips

• Pop-up Blocker Tips
• Word: Tracked Changes
• IRB Tip Archives (common questions and problem areas)

Agreements for Collaborations

Consult the IRB Reliance Agreements webpage to download forms and corresponding instructions.