The Clinical Trials Toolkit is an interactive colour-coded routemap to help navigate through the legal and good practice arrangements surrounding setting up and managing a Clinical Trial of an Investigational Medicinal Product (CTIMP). The routemap distinguishes between legal and good practice requirements, and indicates which aspects of these are relevant to wider clinical research in general. It includes an overview of trial practices, along with more detailed information available at ‘stations’ along the route.

Download a copy of the CT Toolkit routemap (pdf, 221.33 KB).

A leaflet promoting the benefits and features of the CT Toolkit website is available for download. To view the leaflet click here (pdf, 62.64 KB).

Routemap Trial Planning & Design Trial Planning & DesignWithin the scope of the Clinical Trial Regulations? Within the scope of the Clinical Trial Regulations?Risk Assessment Risk AssessmentSponsorship SponsorshipProtocol Development Protocol DevelopmentGCP & Serious Breach Reporting GCP & Serious Breach ReportingTrial Management & Monitoring Trial Management & MonitoringTrial Documentation Trial DocumentationTrial Supplies Trial SuppliesPharmacovigilance PharmacovigilanceR&D Consultation R&D ConsultationFunding Proposal Funding Proposal Peer Review Peer ReviewFunding Secured Funding SecuredTrial Master File Trial Master FileUnique Trial Number Unique Trial NumberEudraCT Number EudraCT NumberConfirm Sponsor Confirm SponsorFeasibility & Investigator Selection Feasibility & Investigator SelectionContracts & Agreements Contracts & AgreementsFinal Protocol Final ProtocolCI Checklist Before Seeking Approval CI Checklist Before Seeking ApprovalIRAS IRASCTA Submission CTA SubmissionEthics Submission Ethics SubmissionR&D Submission R&D SubmissionPermissions & Approvals Obtained Permissions & Approvals ObtainedFinal Trial Management Documentation Final Trial Management DocumentationTrial is Abandoned Trial is AbandonedTrial Begins Trial BeginsInformed Consent Informed ConsentSafety Reporting Safety ReportingProgress Reporting Progress ReportingOngoing Management & Monitoring Ongoing Management & MonitoringMHRA Inspection MHRA InspectionAudit AuditAddition of New Sites & Investigators Addition of New Sites & InvestigatorsSubstantial Amendments Substantial AmendmentsUrgent Safety Measures Urgent Safety MeasuresTemporary Halt or Early Termination Temporary Halt or Early TerminationTrial does not Recommence Trial does not RecommenceEnd of Trial Declaration End of Trial DeclarationStatistical Data Analysis Statistical Data AnalysisClinical Trial Summary Report Clinical Trial Summary ReportDissemination of Results Dissemination of ResultsArchiving Archiving
Hover over routemap to zoom