ORC Tool Box

Template Logs - These tools are to serve as source documents to satisfy federal regulations, Good Clinical Practices, local policy and best practices.

• Delegation of Responsibility Log
  •  Delegation of Responsibility Tool Summary Worksheet
• Site Screening & Enrollment Log
• Telephone Contact Log

• Subject Logs

  • Subject Identification Log
  • Subject Screening Log
  • Subject Enrollment Log
  • Subject Documentation of the Informed Consent
  • Subject Withdrawal and Termination Log
  • Concomitant Medication Log

Human Subject Research Source Document Tools

• Regulatory File Content List
• Subject File Content List and Note to File Information
• Signing, Dating and Correction Source Documents (ALCOA)