Key to Symbols Standard Process Legal Requirement Good Practice
Specific for trials within Directive's scope Standard Practice Legal Requirement gdPractice
Relevant to all trials Standard practice with wider relevance Legal requirement with wider relevance Good practice with wider relevance

Planning a New Trial

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Planning a New Trial GCP (management & monitoring) Trial documentation Trial supplies Pharmacovigilance Checklist before seeking approval Protocol development Final protocol CTA submission To Trial Management and Closure Map To Trial Management and Closure Map Final trial management documentation Approvals & permissions obtained Ethics submission R&D submission Checklist before seeking approval Identify sponsor(s) Unique trial number Obtain EudraCT number Trial master file Funding secured Peer review Funding proposal (if required) R&D consultation Sponsorship Is the trial within the scope of the UK Regulations Research question Is the trial within the scope of the UK Regulations