The University of Tennessee Graduate School of Medicine, Knoxville

Essential Clinical Research Documents

Conducting clinical research necessitates the construction and maintenance of a wide range of essential documents to ensure that research is being conducted in a rigorous and ethical manner that meets regulatory and institutional policy requirements. The Graduate School of Medicine has provided several editable templates to assist our investigators with the development of these essential documents.

• Adverse Events Log
  
  
• Concurrent Medications Log
  
  
• Delegation of Authority Log
  
  
• Drug Study Supply Shipment Log
  
  
• Informed Consent Form Documentation Checklist
  
  
• Master Enrollment Log
  
  
• Master Patient ID Log
  
  
• Monitoring Log
  
  
• Screening Log
  
  
• Telephone Contact Documentation
  
  
• Training Log
  
  
• Essential Research Document Checklist