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 12 - Obtaining Sponsorship (Non-CTIMP) [3.6 Mb]
• SOP 13 - Obtaining Sponsorship (CTIMP) [1.5 Mb]

Standard Operating Procedures (SOPs)

• SOP 1 - Preparation, Review and Issue / Approval of SOPs [810.7 Kb]
• SOP 2 - Approval to Commence a CTIMP [1.5 Mb]
• SOP 3 - Protocol content and format to meet ICH-GCP standards [5.4 Mb]
• SOP 4 - Setting up and maintaining a Trial Master File [1.4 Mb]
• SOP 5 - Serious Breaches of GCP in CTIMPs [2.5 Mb]
• SOP 6 - Managing and Reporting Research related Adverse Events in Clinical Trials of an Investigational Medicinal Product (IMP) [1.5 Mb]
• SOP 7 - Monitoring (Clinical Trials sponsored by Cardiff University) [1.0 Mb]
• SOP 8 - Assessing Insurance Cover [2.7 Mb]
• SOP 10 - Substantial/Non-Substantial Amendments for CTIMPs [898.7 Kb]
• SOP 12 - Obtaining Sponsorship (Non-CTIMP) [3.6 Mb]
• SOP 13 - Obtaining Sponsorship (CTIMP) [1.5 Mb]
• SOP 15 - Sponsor Close Down Visits [531.4 Kb]
• SOP 18 - IMP Management: Setting up a Clinical Trial [2.7 Mb]
• SOP 19 - Unblinding in a Clinical Trial [1.9 Mb]
• SOP 20 - Data Management [1.1 Mb]
  SOP 21 - Case Report Form Design and Completion [93.5 Kb]
• SOP 22 - Archiving [4.2 Mb]

Guidelines

Templates