Clinical Trials of Investigational Medicinal Products (CTIMPs)
Creation, Control, Amendment and Storage of Standard Operating Procedures for Research Governance
Development, Review and Amendment: Study Protocol
The Ethical Approval of Research
Consent Form Template (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 be included if appropriate for the study).
Delegation of Responsibilities
Reporting and Managing Research Related Adverse Events
Preparation, Completion, Signing and Correcting Case Report Forms
Setting up, Maintaining and Achiving Trial Master File(s)/Site Master File(s) for CTIMPs
Education, Training and Experience
Application to MHRA for Clinical Trials Authorisation
Amendments to Protocols and Essential Documentation
Production of Progress, Safety and Final Reports
Indemnity and Sponsorship of research studies
Good Clinical Practice: Inspections
Data Management: Collection, Validation and Storage
Matters of Non-compliance with Study Protocol
Termination or Suspension of a Research Study
Risk Assessment of Research Studies
Publication and Dissemination of Study Outcomes
Monitoring of Clinical Trials of Investigational Medicinal Products
Complaints from Research Participants
Breach of Patient Confidentiality in IMP Studies
Contracting Procedure for Clinical Trials of Investigational Medicinal Products (CTIMPs)
