Documents

Research and Development Policies

If you need to copy and paste information from PDF files such as the ones listed below you can do so by changing to text select mode in Acrobat Reader.

You do this by clicking the text select button on the Adobe Acrobat toolbar next to the hand tool.

• Safety Reporting in Clinical Research Policy (pdf, 450 KB)
  
  • See templates for Serious Adverse Events Reporting Form and related templates, below
    
• Sponsorship of Clinical Research Studies (pdf, 346 KB)
• Capacity and Capability Approval for Clinical Research (pdf, 336 KB)
• Monitoring and Audit of Clinical Research Studies (pdf, 337 KB)
• Research Passports, Honorary Research Contracts and Letters of Access Policy (pdf, 349 KB)
• Integrity in Clinical Research Policy and Procedure (pdf, 292 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)