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Planning a New Trial

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Key to Symbols Standard Process Legal Requirement Good Practice
Specific for trials within Directive's scope
Relevant to all trials
Sponsorship Trial documentation Trial supplies Pharmacovigilance CTA submission Ethics submission R&D submission Identify sponsor(s) Peer review Unique trial number Obtain EudraCT number Trial master file Funding secured R&D consultation Funding proposal (if required) Approvals & permissions obtained Final trial management documentation Final protocol GCP (management & monitoring) Protocol development Checklist before seeking approval Checklist before seeking approval Research question Is the trial within the scope of the UK Regulations To Trial Management and Closure Map Feasibility & Investigator Selection GCP & Serious Breach Reporting Trial is abandoned Informed consent IRAS Temporary halt or early termination Trial does not recommence Contracts & agreements Urgent Safety Measures Addition of new sites and Investigators Substantial Amendments MHRA Inspection Audit Ongoing management and Monitoring Progress Reporting Safety Reporting End of Trial Declaration Statistical Data Analysis Clinical Trial Summary Report Dissemination of Results Archiving

Useful resources