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)
Adverse Events (AE) Forms/Logs
Johns Hopkins Adverse Event log
NIH Adverse Event Form
NIH Serious Adverse Event Form
Concomitant Medication Forms
NIH Concomitant Medication Form
Wisconsin Concomitant Medication Log
Delegation of Authority Log (DOAL)/Forms
NIH Delegation of Responsibilities
NIH Delegation of Authority Log
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 Amendment
Protocol Amendment Tracking Log
Protocol Deviation Log
Protocol Deviation Log
Recrural Retention Plan
NIH Recrural Retention Plan
Regulatory Binder/Essential Documents
TN-CTSI Regulatory Binder Tabs and Essential Documents
NIH Regulatory Binder Guidance
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
