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Forms, Procedures, SOPs and Guidelines

Research Governance Frameworks


Sponsorship & Contractual Matters

The Advanced Project Information Proforma (APIP) must be completed for all studies referred to Research Governance and Contracts (e.g. where Cardiff University is requested to act as Sponsor and/or where contracts are required).

 

Please refer to the following SOPs when applying for Sponsorship from Cardiff University:

Additional Sheets:
Additional IMP [88.0 Kb]
Insurance Referrals

Standard Operating Procedures (SOPs) 

Cardiff University has a number of Framework SOPs (F-SOPs) and SOPs in place for Clinical Trials of Investigational Medicinal Products (CTIMPs), which cover a range of clinical trial procedures, including:

  • Preparation, review and approval of SOPs;
  • IMP Management;
  • Clinical Safety Reports;
  • Substantial and non-substantial amendments;
  • Data Management;
  • Trial Close Down;
  • Safety Reporting (PV);
  • Risk Assessment;
  • Trial Monitoring Plans;
  • Unblinding;
  • Non-compliance and serious breaches;
  • Approval to commence a CTIMP;
  • Setting up and maintaining a TMF;
  • Audits;
  • Archiving records in a CTIMP.

Cardiff University F-SOPs and SOPs relating to CTIMPs are now accessed via the Q-Pulse Active register (University staff only). You can also request copies of F-SOPs and SOPs directly from the Research Governance Team, by contacting: 029 20 879131/resgov@cardiff.ac.uk

Framework Standard Operating Procedures (F-SOPs)

For use in CTIMPs only


Guidelines


Policies


Templates

 

All CTIMP template documents are available via Q-Pulse and can be requested from the Research Governance Team- 029 20 879131/resgov@cardiff.ac.uk