Research Governance Frameworks

• Research Governance Framework for Cardiff University [223.0 Kb]
• Research Governance Framework for Health and Social Care in Wales (Second edition, 2009) [616.8 Kb]

Sponsorship

• SOP - Obtaining Sponsorship (Non-CTIMP) [3.6 Mb]
• SOP - Obtaining Sponsorship (CTIMP) [4.4 Mb]

Standard Operating Procedures (SOPs)

• SOP - Preparation, Review and Issue / Approval of SOPs [1.8 Mb]
• SOP - Approval to Commence a CTIMP [1.5 Mb]
• SOP - Protocol content and format to meet ICH-GCP standards [5.4 Mb]
• SOP4 Setting up and Maintaining a Trial Master File [5.1 Mb]
• SOP- Serious Breaches of GCP in CTIMPs [2.5 Mb]
• SOP6 Managing and Reporting Research related Adverse Events in Clinical Trials of an Investigational Medicinal Product (IMP) [1.5 Mb]
• SOP - Monitoring (Clinical Trials sponsored by Cardiff University) [2.5 Mb]
• SOP- Assessing Insurance Cover [2.7 Mb]
• SOP Substantial/Non-Substantial Amendments for CTIMPs [2.2 Mb]
• SOP - Obtaining Sponsorship (Non-CTIMP) [3.6 Mb]
• SOP - Obtaining Sponsorship (CTIMP) [4.4 Mb]
• SOP - Sponsor Close Down Visits [1.6 Mb]
• SOP - IMP Management: Setting up a Clinical Trial [2.7 Mb]
• SOP19 Unblinding in a Clinical Trial [1.0 Mb]
• SOP20 Data Management [1.1 Mb]
  SOP - Case Report Form Design and Completion [93.5 Kb]
• SOP22- Archiving [4.2 Mb]

Templates