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 EudraCT Number 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 Unique Trial Number 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