Clinical Trials of Investigational Medicinal Products

Clinical Trials of Investigational Medicinal Products Standard Operating Procedures

The standard operating procedures below are in pdf format.

• Amendments to Protocols and Essential Documentation‌ (pdf)
• Application to MHRA for Clinical Trials Authorisation‌ (pdf)
• Audit of Laboratories to Good Clinical Practice Standards‌ (pdf)
• Breach of Patient Confidentiality in IMP Studies‌ (pdf)
• Clinical Investigations of Medical Devices (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).
• Contracting Procedure for CTIMPs‌ (pdf)
• Data Management: Collection, Validation and Storage‌ (pdf)
• Delegation of Responsibilities‌ (pdf)
• Development, Review and Amendment: Study Protocol (pdf)
• Education, Training and Experience‌ (pdf)
• End of Study Declaration‌ (pdf)
• Good Clinical Practice: Inspections‌ (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)
• Monitoring of Clinical Trials of Investigational Medicinal Products‌ (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)
• Reporting and Managing Research Related Adverse Events‌ (pdf)
• Research Governance: Audit‌ (pdf)
• Risk Assessment of Research Studies‌ (pdf)
• Setting up, Maintaining and Achiving Trial Master File for CTIMPs‌ (pdf)
• Termination or Suspension of a Research Study‌ (pdf)
• The Ethical Approval of Research‌ (pdf)