Tools and Templates
Quality Assurance for Clinical Trials
Study Planning
- Clinical Electronic Structured Harmonised Protocol (CeSHarP) M11 Template
- Critical to Quality Factors Principles Document
- Critical to Quality Factors Table Template
- Risk Management Plan Template
- Data Management Plan Template
- Data Safety Monitoring Board Charter Template
- Investigational Product Management Template
- Guidance for Developing Monitoring Plans
Study start up
- Interactive Clinical Research Study Startup Checklist
- Essential Documents
- Delegation of Authority Log
- Team Training Log
- Regulatory Binder Table of Contents Template
- Clinical Study Feasibility Checklist
- Site Selection Visit Checklist
- Site Activation Checklist
- Site Activation letter Template
- Recruitment Plan Outline