Route Maps

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• Trials that Began Before 1st May 2004
• Planning a New Trial

  • Research Question

  • Is the trial within the scope of the UK Regulations?

  • Sponsorship

  • Protocol Development

  • GCP (Management and Monitoring)

  • Trial Documentation

  • Trial Supplies

  • Pharmacovigilance

  • R&D Consultation

  • Funding Proposal (if required)

  • Peer Review

  • Funding Secured

  • Trial Master File

  • Unique Trial Number

  • Obtain EudraCT Number

  • Identify Sponsor(s)

  • Final Protocol

  • CI Checklist before seeking approvals

  • R&D Submission

  • Ethics Submission

  • CTA Submission

  • Approvals and Permissions Obtained

  • Final Trial Management Documentation

• Trial Management and Closure

Unique Trial Number

Each trial must have a unique trial protocol number before a EudraCT number can be obtained, to ensure uniqueness, it is recommended that you use the ISRCTN number for this purpose. If your trial is not covered by the UK Regulations, it is good practice to register your randomised controlled trial on the ISRCTN database. All MRC–funded trials should have an ISRCTN number. The website below shows you how to obtain one.

For trials for which all costs have been met by the NHS Trust, registration on the NHS Clinical Trial Register and ISRCTN register is done automatically after the trial has been approved. More information on this can be found in the last resource.

There is an ongoing project looking at all aspects of trial registration. Outcomes of this work will be published on the toolkit.

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