The procedures below are detailed in pdf format.
- Amendments to Protocols and Essential Documentation (pdf)
- Archiving Research Study Documents (pdf)
- Complaints from Research Participants (pdf)
- Consent Form Template (doc) (Consent forms may vary according to the nature of the study. The template consent form is suitable for most studies but may require alteration. Text in red or within square brackets indicates wording that should only be included if appropriate for the study.)
- Creation Control Amendment and Storage of SOPs for Research Governance (pdf)
- Data Management Collection, Validation and Storage (pdf)
- Delegation of Responsibilities (pdf)
- Development Review and Amendment Study Protocol (pdf)
- Education, Training and Experience (pdf)
- Education, Training and Experience (pdf)
- Indemnity and Sponsorship of Research Studies (pdf)
- Informed Consent for Research (pdf)
- Maintaining Laboratory Books (pdf)
- Matters of Non-compliance with Study Protocol (pdf)
- Preparation, Completion, Signing and Correcting Case Report Forms (pdf)
- Production of Progress, Safety and Final Reports (pdf)
- Publication and Dissemination of Study Outcomes (pdf)
- Research Governance Audit (pdf)
- Risk Assessment of Research Studies (pdf)
- Termination or Suspension of a Research Study (pdf)
- The Ethical Approval of Research (pdf)