Study Planning

• FDA Part 11 Epic Certification
• Feasibility Assessment Checklist
• PI Supervisory Plan for Clinical Research
• Comprehensive Monitoring Plan
• Concise Monitoring Plan

Study Start-Up

• Signature & Delegation of Authority Log
• Training Log
• Financial Disclosure Form

Recruitment and Enrollment

• Eligibility Checklist
• Informed Consent Process/Discussion Checklist
• Enrollment Documentation
• Enrollment Log
• Master Participant ID Log

Study Conduct

• Good Clinical Practices Checklist
• Protocol Amendment Log
• Concomitant Medication Log
• Adverse Event Log
• SAE Log
• Deviation Log
• Device Accountability Log
• Monitoring Visit Log
• Inventory List for Study Storage Documents

Study Close-Out

• Close-out Checklist
• Transfer of Subject Checklist

Visit the NCCIH Clinical Research Toolbox for an A to Z repository of forms, logs, and checklists to inform clinical study start-up and conduct.

Standard Operation Procedures (SOPs)

Below, you’ll find a curated list of SOP templates to streamline your research processes and maintain adherence to Good Clinical Practice (GCP) and FDA regulations.

• Data Managment
• Informed Consent Process
• Management and Reporting Adverse Events
• Training