S A Overarching SOPs Funding Secured Training Records

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Presentation transcript:

S A Overarching SOPs Funding Secured Training Records Managament of External Staff File Notes GCP Training Conduct of Research Studies and trials Study related emails Expedited trust approval Safety Reporting SOP062 Trial Master File Funding Proposal SOP023 SOP009 SOP024 Progress Reporting R&D Consultation EudraCT No. CTA Submission Peer Review Unique Trial No. SOP014 Ongoing management & monitoring Within scope of CT regulations? Final Protocol SOP016 Trial Abandoned S Sponsorship Confirm Sponsor SOP048 Trial Planning & Design Risk Assessment Permissions & Approvals Obtained SOP065 Trial Begins End of Trial Declaration MHRA Inspection Dissemination of Results IRAS SOP031 SOP021 A Feasibility & Investigator Selectiiu8o9on Ethics Submission Final Trial management documentation Informed Consent Audit Statistical Data Analysis CI Checklist before seeking approval Archiving SOP063 Clinical Trial Summary SOP011 SOP005 SOP003 SOP015 SOP013 SOP060 SOP041 SOP030 SOP017 Substantial amendments Protocol Development Contracts & Agreements SOP018 SOP019 SOP037 Addition of new sites & investigators R&D Submission SOP066 SOP024 SOP034 SOP025 SOP038 GCP & Serious breach reporting Urgent safety measures Trial Documentation SOP050 SOP051 SOP052 SOP020 SOP060 Trial management & monitoring SOP071 SOP009 Trial Supplies Pharmacovigilence SOP072 SOP073 SOP074 SOP075 SOP076 SOP081 SO Key to Symbols Demonstrates processes that can be done in parallel Demonstrates that not all processes will apply to all trials Relevant to all trials Specific for trials within Directive’s scope Standard Process Legal Requirement Good Practice SOP012 SOP069 SOP079 Temp halt or early termination Trial does not recommence SOP077 SOP078 SOP080 Data Managment