An official website of the United States governmentNCCIH Clinical Research Toolbox 508-Compliant PDFs
The following PDFs are fully accessible versions of the Word documents presented for the NCCIH Clinical Research Toolbox, when that document could not be made fully compliant in Word. Please see the full NCCIH Clinical Research Toolbox for descriptions of these files and more.
Clinical Research Start Up
Data Safety and Monitoring
- Data and Safety Monitoring Plan (DSMP) Independent Monitoring [337KB PDF]
- Independent Monitoring Committee (IMC) Report Template [468KB PDF]
- Independent Monitoring Committee (IMC) Charter Template [342KB PDF]
Study Accrual and Retention Plan Template
Case Report Forms
- Adverse Event Forms [95KB PDF]
- Documentation of Informed Consent [530KB PDF]
- Medical History (a) [80KB PDF]
- Medical History (b) [75KB PDF]
- Physical Exam [100KB PDF]
- Prior and Concomitant Medications [85KB PDF]
- Serious Adverse Events Form [550KB PDF]
Protocol Associated Documents
Essential Documents/Regulatory Binder
- Regulatory Binder Checklist [545KB PDF]
- Essential Regulatory Documents Guidance and Binder Tabs [2.2MB PDF]
- FDA Document History Log [530KB PDF]
- Delegation of Authority Log [560KB PDF]
- Training Log [530KB PDF]
- Specimen Tracking Log [540KB PDF]
- Unanticipated Problem (UP) Form [580KB PDF]
- Protocol Deviation Tracking Log [600KB PDF]
- Monitoring Visit Log [530KB PDF]
- NCCIH Document History Log [585KB PDF]
Pharmacy/Investigational Product
- Investigational Product Accountability Log: Stock Record [640KB PDF]
- Investigational Product Accountability Log: Subject Record [640KB PDF]
Quality Management
- Quality Management Study-wide Review Tool [640KB PDF]
- Quality Management Subject Review Tool [610KB PDF]
Documents Used During the Conduct of Clinical Research
- Unanticipated Problem (UP) Form [580KB PDF]
- Site Screening and Enrollment Log [530KB PDF]
- NCCIH Policy on Protocol Amendments [570KB PDF]