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It organizes materials into key sections including Trial Summary, version control, contact details, trial-specific documentation, sponsorship and NHS permissions, site personnel items, finance records, ethics and MHRA correspondence, amendments, pharmacovigilance outputs, safety reporting, randomisation and code-break procedures, pharmacy requirements, data management planning, and publication-related data collection artifacts. 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SOP013; SOP011;\u003Cbr>SOP052; SOP055; SOP064 |\n| 2 | Version control log | Version control template |  | SOP043 |\n| 3 | Contact details sheet | Insert contact details from protocol |  |  |\n| 4 |  | File note form |  | SOP041 |\n| Trial Specific Documentation |  |  |  |  |\n| 5 | Current approved protocol with signatures | Protocol Template CTIMP |  | SOP019 |\n| 6 | Approved Patient Information Sheet (PIS), Informed Consent Form, GP Letter | Patient Information Sheet and Consent  Form Template | GP Letter template | SOP020; SOP003; SOP060 |\n| 7 | Previous versions of protocol(s), PIS, Informed Consent Form, GP Letter |  |  |  |\n| 8 | Study specific Standard Operating Procedures |  |  |  |\n| Sponsorship and NHS permission |  |  |  |  |\n| 9 | Trust Approval Letter |  |  | SOP034 |\n| 10 | Letter of acceptance of sponsorship |  |  | SOP048 |\n| 11 | Peer Review |  |  |  |\n| 12 | Sponsorship delegation log | Delegation of sponsor responsibilities form |  |  |\n| 13 | Project Management Delegation Log |  | MHRA Project Management Considerations  Table | SOP055 |\n| 14 | Risk Assessment and superseded versions | CTIMP Risk Assessment form |  | SOP065 |\n| Site Personnel |  |  |  |  |\n\nGD004: Sponsor File Index with hyperlinks  \nVersion 1.0 Review Date: January 2019 Page 1 of 6  \nTrial Master File Index with hyperlinks to templates  \n\n| 15 | Up-to-date, signed and dated CVs and GCP training records |  |  | SOP049 |\n| --- | --- | --- | --- | --- |\n| 16 | Delegation Log | Delegation log template |  | SOP030 |\n| Finance |  |  |  |  |\n| 17 | Grant Application |  |  |  |\n| 18 | Clinical Trial Agreement / Funding agreement letters |  |  | SOP023; SOP024; SOP066 |\n| 19 | Finance correspondence: funder / contracts |  |  |  |\n| 20 | Indemnity certificates / policy |  |  |  |\n| 21 | Site Agreements | Model clinical trial agreements web link |  |  |\n| 22 | Research Account statements |  |  |  |\n| 23 | Invoices |  |  |  |\n| 24 | Finance correspondance with sites |  |  |  |\n| 25 | Other finance correspondence other than contracts |  |  |  |\n| Ethics & MHRA |  |  |  |  |\n| 26 | EUDRACT number | EudraCT website |  |  |\n| 27 | HRA correspondence | weblink to HRA Approval info page |  |  |\n| 28 | Adoption onto the NIHR portfolio |  |  |  |\n| 29 | Ethics application including correspondence | web link to REC approval information |  | SOP005 |\n| 30 | Favourable Ethical Approval letter |  |  |  |\n| 31 | MHRA application including correspondence | web link for gaining MHRA approval information |  | SOP014 |\n| 32 | Clinical Trial Authorisation letter |  |  |  |\n| 33 | Copy of the Annual Progress Report(s) to Ethics | HRA website link giving up-to-date information |  |  |\n| 34 | Copy of the end of trial notification form and report sent to Ethics & MHRA |  |  |  |\n| Amendments |  |  |  |  |\n\nGD004: Sponsor File Index with hyperlinks  \nVersion 1.0 Review Date: January 2019 Page 2 of 6  \nTrial Master File Index with hyperlinks to templates  \n\n| 35 | Amendments to ethical approval a separate bundle of documents filed in chronological order for each amendment comprising copies of:\u003Cbr>1) all the amended documentation\u003Cbr>2) approval – Ethics; MHRA; HRA; R&D (as required) | web link to MHRA amendment process | web link to which bodies need to approve an  amendment | SOP037 |\n| --- | --- | --- | --- | --- |\n| 36 | Correspondence regarding the amendment |  |  |  |\n| Pharmacovigilence |  |  |  |  |\n| 37 | Investigators Brochure (IB) and/or Summary of Product Characteristics (SmPC) and updates | SmPC / IB Checklist | Link to website to check for updates to SmPC ","cbCainZm4d3hF9j8","https://ap.wps.com/l/cbCainZm4d3hF9j8","pdf",493054,6,"English","# Essential documents required for Trial Master File\n## Trial Specific Documentation\n## Sponsorship and NHS permission\n## Site Personnel\n# Finance\n# Ethics & MHRA\n## Amendments\n# Pharmacovigilence\n# Pharmacy\n# Data collection, analysis and publication","[{\"question\":\"What is included in the essential Trial Master File section?\",\"answer\":\"It covers Trial Summary, a version control log, and contact details, followed by key trial-specific documentation items such as the current approved protocol and patient-facing documents.\"},{\"question\":\"How does the index organize sponsorship, approvals, and ethics material?\",\"answer\":\"It groups items by Trust approval, acceptance of sponsorship, peer review, sponsorship delegation logs, project management considerations, risk assessment, and required correspondence for ethics and MHRA authorisation, including copies and notifications.\"},{\"question\":\"Which pharmacovigilance and safety documents are listed?\",\"answer\":\"It includes investigators’ brochure/SmPC updates, SAE/SUSAR/DSUR reports, sponsor responsibilities for safety reporting, and procedures related to randomisation, unblinding, and any required code-break requests.\"}]","GD004 - Sponsor File Index with hyperlinks - Version 1.0 - Trial Master File | PDF"]