Research Monitoring & Oversight: Helpful Tools

Checklists

Log Templates

• Device Accountability Log 
• Drug Accountability Log
• Monitoring Log
• Protocol Deviation Tracking
• Retained Body Fluids/Tissue Sample Log 
• Screening Log
• Serious Adverse Event Tracking Log 
• Site Signature and Responsibility Log 
• Subject Enrollment
• Subject Identification Log 

Guidance Documents:  These documents are provided for guidance only, and are not intended to be all-inclusive.  They do not replace published regulations governing human subjects research.

• Protocol Deviations
• Setup and Maintenance of a Regulatory Binder
• FDA Audit