Routemap

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.

*Mobile users will be able to access the stations from the list shown 

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

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

Getting Started with the Routemap

The Clinical Trials Toolkit is designed to help understand the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations, which together with its amendments, are referred to as the Clinical Trial Regulations within this Toolkit. 

Users should note the following features;

  • The positioning of the stations (from left to right on the routemap or from top to bottom on the station list) gives an indication of the critical path and process flow.
  • Activities that may be undertaken in parallel are indicated on the routemap and explained within each station.
  • By clicking on a station, you will be taken to a description of the process and a list of relevant resources and/or related stations.
  • Station symbols can either apply to trials covered by the CT Regulations, or apply to all trials (please see the key to symbols).
  • Where a station includes statutory requirements for CTIMPs, (even if the requirement is not a general legal requirement for non-CTIMPs) the station, by default, will be identified as a legal requirement.
  • In many cases, good practice requirements may be considered mandatory even if the requirement does not have statutory force  (e.g. by Funders or the NHS).
  • Stations are grouped into four categories: Planning, Approval, Recruitment, and Close Out.

Before using the routemap, take time to think about your trial and its setting. Consider the following:

  • The research question
    The nature of the intervention will determine whether the trial is subject to the regulations. The routemap contains advice on management arrangements for different kinds of trial.
  • Where you are in the trial process
    The key stages of the trial process are identified as ‘stations’. By selecting a station you will find one or more ‘resources’. The resources provide advice and links to other useful websites and resources.
  • The expertise of your trials team and organisation
    Some resources within the Toolkit address the needs of trialists, whilst others are of particular interest to those involved with R&D management. Using the resources may reveal gaps in the capacity of your trials team or organisation to support trials to the required standards. Organisations vary considerably in how they approach their responsibilities to support high quality clinical trials.
  • The importance of Patient and Public Involvement  
    Consider how best to involve members of the public in your work. See NIHR’s briefing notes for researchers. 

PPI guidance for Chief Investigators of UK surgical trials has been developed from the 'Patient and public involvement Intervention to enhance Recruitment and Retention in Surgical Trials' (PIRRIST) project. 

Trials that began before 1 May 2004

The Medicines for Human Use (Clinical Trials) Regulations came into force on 1 May 2004. Any trials initiated before this date (i.e. trials which had a Clinical Trial Certificate (CTC) or Clinical Trial Exemption (CTX) or which had been notified under the Doctors and Dentists Exemption (DDX) scheme) and that were ongoing after 1 May 2004 were required to ensure that systems were put in place  to comply with these regulations.

The MRC/DH Joint Project produced a Checklist for Ongoing Trials in 2004 which helped sponsors identify any immediate actions to be taken in relation to their trials. The MHRA also published advice on amendments or end of trial declarations for clinical trials that were originally CTX/DDX/CTC applications.