Jump to top menu Jump to main menu Jump to content

tijdlijn-test

CT Toolkit 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 http://www.nets.nihr.ac.uk/funding/ 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 SubmissionTrial begins 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

routemap Randomised Controlled Trials Qualitative and mixed methods studies Technology Assessment Reports Pilot and Feasibility Studies Economic Evaluations References Reporting guidelines PGfAR Dual publication Forms Permissions Copyright Abstract Scientific summary Plain English summary Report submission Evidence Synthesis/ Systematic Reviews Editorial review process Step by step guide to obtaining permissions Editorial policies Editorial review timescales Production process Dissemination Open access Production timescale Publication ethics End of Trial Declaration Safety Reporting MHRA Inspection Substantial Amendments Final Trial Management Documentation Archiving Ongoing Management & Monitoring Urgent Safety Measures Temporary Halt Early Termination CTA Submission Ethics Submission Informed Consent Permissions & Approvals Obtained R&D Submission Trial Master File Confirm Sponsor Sponsorship Protocol Development Trial Management & Monitoring Trial Supplies Pharmacovigilance Trial Documentation Final Protocol Addition of New Sites & Investigators Risk Assessment Peer Review Audit Trial is abandoned Dissemination of Results Clinical Trial Summary Report Progress Reporting IRAS Contracts & Agreements Feasibility & Investigator Selection Statistical Data Analysis R&D Consultation Trial Planning & Design Trial Registration Trial Begins CI Checklist Before Seeking Approval Funding Secured Funding Proposal Within the scope of the CT Regulations ? Key to symbols Demonstrates processes that can be done in parallel Demonstrates that not all processes will apply to all trials GCP & Serious Breach Reporting
Hover over routemap to zoom

CT Toolkit 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 http://www.nets.nihr.ac.uk/funding/ 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 SubmissionTrial begins 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

routemap Randomised Controlled Trials Qualitative and mixed methods studies Technology Assessment Reports Pilot and Feasibility Studies Economic Evaluations References Reporting guidelines PGfAR Dual publication Forms Permissions Copyright Abstract Scientific summary Plain English summary Report submission Evidence Synthesis/ Systematic Reviews Editorial review process Step by step guide to obtaining permissions Editorial policies Editorial review timescales Production process Dissemination Open access Production timescale Publication ethics End of Trial Declaration Safety Reporting MHRA Inspection Substantial Amendments Final Trial Management Documentation Archiving Ongoing Management & Monitoring Urgent Safety Measures Temporary Halt Early Termination CTA Submission Ethics Submission Informed Consent Permissions & Approvals Obtained R&D Submission Trial Master File Confirm Sponsor Sponsorship Protocol Development Trial Management & Monitoring Trial Supplies Pharmacovigilance Trial Documentation Final Protocol Addition of New Sites & Investigators Risk Assessment Peer Review Audit Trial is abandoned Dissemination of Results Clinical Trial Summary Report Progress Reporting IRAS Contracts & Agreements Feasibility & Investigator Selection Statistical Data Analysis R&D Consultation Trial Planning & Design Trial Registration Trial Begins CI Checklist Before Seeking Approval Funding Secured Funding Proposal Within the scope of the CT Regulations ? Key to symbols Demonstrates processes that can be done in parallel Demonstrates that not all processes will apply to all trials GCP & Serious Breach Reporting
Hover over routemap to zoom