Documents

Research and Development Policies

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• 001 Safety Reporting in Clinical Research (pdf, 311 KB)
  
  • See templates for Serious Adverse Events Reporting Form and related templates, below
    
• 002 Sponsorship of Clinical Research Studies (pdf, 142 KB)
• 003 Trust Management Approval for Clinical Research (pdf, 151 KB)
• 005 Monitoring and Audit System for Research Projects (pdf, 317 KB)
• 006 Research Passports, Honorary Research Contracts and Letters of Access (pdf, 650 KB)
• Integrity in Clinical Research (pdf, 185 KB)
• Research Access to Notes Registration Form (Word, 48 KB)
• Intellectual Property Policy (pdf, 264 KB)

Templates for Standard Operating Procedures (SOPs)

• Archiving of Essential Documents (Word, 59 KB)
• Case Report Form Completion (Word, 57 KB)
• Clinical Device Protocol Template (Word, 228 KB)
• Clinical Research Study Protocol Template (Word, 81 KB)
• Clinical Trial Protocol Template (Word, 103 KB)
• Database Design (Using Excel) (Word, 2.8 MB)
• Design and Development of Case Report Forms (Word, 77 KB)
• Document Control (Word, 62 KB)
• Ethics Committee Application (Word, 69 KB)
• Feasibility Questionnaire (Word, 516 KB)
• Informed Consent (Word, 74 KB)
• Preparation and Approval of Protocol Amendments (Word, 65 KB)
• Qualitative Research Study Protocol Template (Word, 54 KB)
• Template for creating Standard Operating Procedures (Word, 53 KB)