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19/03/2026)\u003Cbr>Previous versions of the protocol should be marked as superseded |\n| --- | --- |\n| Section 2: PIL | • Patient Information Sheet\u003Cbr>• Consent Form\u003Cbr>• Patient Invitation Letter |\n| Section 3: Regulatory & other essential documents | • Main NHS REC Application Form (including Chief Investigator and Sponsor signatures)\u003Cbr>• Main NHS REC Approval\u003Cbr>• SSI Application Form (including signatures)\u003Cbr>• R&D Approval Letter (and LREC approval if applicable)\u003Cbr>• Notice of Substantial Amendment & Approval Letters\u003Cbr>• Sponsorship Agreement |\n| Section 4: Finance | • Centre Agreement (including signaturesand Appendix 4)\u003Cbr>• Finance Set up Details Form\u003Cbr>• Appendix 1 Finance Details |\n| Section 5: Standard Operating Procedures | • Waist Measurement SOP |\n| Section 6: Enrolment | • Patient Enrolment Log\u003Cbr>• Original Copy of Consent Form |\n| Section 7: CVs | • Delegation Log of all staff involved in study\u003Cbr>• CV’s\u003Cbr>• GCP Certificates |\n| Section 8: Pathology | • Laboratory Ranges |\n| Section 9: Monitoring | • CRA Visit Log\u003Cbr>• Audit Reports |\n| Section 10: Correspondence & Additional Forms | • Correspondence |\n| Section 11: Annual Ethics Progress Reports |  |","cbCaispycpLO2Zzi","https://ap.wps.com/l/cbCaispycpLO2Zzi","pdf",314751,"English","# Section 1: Protocol\n## Protocol Versions\n# Section 2: PIL\n## Patient Documents\n# Section 3: Regulatory & Other Essential Documents\n## NHS REC and R&D Approvals\n# Section 4: Finance\n## Centre Agreement and Finance Forms\n# Section 5: Standard Operating Procedures\n## Waist Measurement SOP\n# Section 6: Enrolment\n## Patient Logs and Consent\n# Section 7: CVs\n## Staff Delegation and GCP\n# Section 8: Pathology\n## Laboratory Ranges\n# Section 9: Monitoring\n## Audit and Visit Logs\n# Section 10: Correspondence & Additional Forms\n# Section 11: Annual Ethics Progress Reports","[{\"question\":\"What is the current version of the BADBIR protocol?\",\"answer\":\"The current protocol version is 22, dated 19/03/2026.\"},{\"question\":\"What documentation must be maintained in the CVs section?\",\"answer\":\"This section requires the delegation log for all involved staff, current CVs, and valid GCP certificates.\"},{\"question\":\"Where should the laboratory ranges be kept?\",\"answer\":\"Laboratory ranges must be filed within Section 8: Pathology.\"}]","BADBIR Investigator Site File - Contents - Protocol 22 | PDF",1789824831]