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This page contains examples of forms/tools needed while conducting research studies. These are to be utilized as examples/guides and will need to be revised to fit the needs of your particular study.

ALCOA-C (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete)

HIPAA Privacy Rule Compliance
  • HIPPA Privacy Rule Compliance
  • Inclusion/Exclusion (I/E) Eligibility Document
  • TN-CTSI Eligibility Document
  • Informed Consent Process (ICP) Continuation of Participation Documentation Form
  • TN-CTSI ICP Continuation of Participation Documentation Form
  • Manual of Operations (MOP)
  • NIH Guide for Developing a MOP
  • Monitor Log
  • Monitor Log
  • NCCIH Tool Summary Sheet: Investigational Product Accountability Log
  • Investigational Product Accountability Log
  • NIMH Investigational Product Storage Temperature Log Template
  • Temperature Log
  • Note to Study File
  • Note to File
  • Protocol Deviation Log
  • Protocol Deviation Log
  • Recrural Retention Plan
  • NIH Recrural Retention Plan
  • Screening/Enrollment Log
  • TN-CTSI Screening and Enrollment Log
  • Standard Operating Procedures (SOPs)
  • NIH Standard Operating Procedure
  • Study Team Meeting Notes
  • Study Team Meeting Notes
  • Training Log
  • NIH Training Log
  • Clinical Research Protocol Template
  • Clinical Research Protocol
  • UTHSC OCR Protocol Violation Log
  • UTHSC OCR Protocol Violation Tracking Log
  • ARRIVE Essential 10
  • ARRIVE Essential 10