GD004 - Sponsor File Index with hyperlinks - Version 1.0 - Trial Master File

Sep 12, 2026

Trial Master File Index with hyperlinks provides a structured checklist of essential sponsor documents required to support authorisation and conduct of clinical trials in the UK. 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. Each entry is mapped to relevant templates and SOP references to streamline submission and maintenance.

LanguageEnglish

CategoryForms

FormatPDF

Pages6

Reading Time2 min

AccessFree to download

Essential documents required for Trial Master File

Trial Specific Documentation

Sponsorship and NHS permission

Site Personnel

Finance

Ethics & MHRA

Amendments

Pharmacovigilence

Pharmacy

Data collection, analysis and publication

Trial Master File Index with hyperlinks to templates | | | Guidance from the MHRA on gaining authorisation in the UK | | | | --- | --- | --- | --- | --- | | | | | | | | | Essential documents required for Trial Master File | Templates | Templates | Relevant SOPs | | 1 | Trial Summary | Insert Executive summary and flow diagram from the protocol. | Clinical Trials Toolkit-Routemap web link | Generic: SOP009; SOP013; SOP011;
SOP052; SOP055; SOP064 | | 2 | Version control log | Version control template | | SOP043 | | 3 | Contact details sheet | Insert contact details from protocol | | | | 4 | | File note form | | SOP041 | | Trial Specific Documentation | | | | | | 5 | Current approved protocol with signatures | Protocol Template CTIMP | | SOP019 | | 6 | Approved Patient Information Sheet (PIS), Informed Consent Form, GP Letter | Patient Information Sheet and Consent Form Template | GP Letter template | SOP020; SOP003; SOP060 | | 7 | Previous versions of protocol(s), PIS, Informed Consent Form, GP Letter | | | | | 8 | Study specific Standard Operating Procedures | | | | | Sponsorship and NHS permission | | | | | | 9 | Trust Approval Letter | | | SOP034 | | 10 | Letter of acceptance of sponsorship | | | SOP048 | | 11 | Peer Review | | | | | 12 | Sponsorship delegation log | Delegation of sponsor responsibilities form | | | | 13 | Project Management Delegation Log | | MHRA Project Management Considerations Table | SOP055 | | 14 | Risk Assessment and superseded versions | CTIMP Risk Assessment form | | SOP065 | | Site Personnel | | | | | GD004: Sponsor File Index with hyperlinks Version 1.0 Review Date: January 2019 Page 1 of 6 Trial Master File Index with hyperlinks to templates | 15 | Up-to-date, signed and dated CVs and GCP training records | | | SOP049 | | --- | --- | --- | --- | --- | | 16 | Delegation Log | Delegation log template | | SOP030 | | Finance | | | | | | 17 | Grant Application | | | | | 18 | Clinical Trial Agreement / Funding agreement letters | | | SOP023; SOP024; SOP066 | | 19 | Finance correspondence: funder / contracts | | | | | 20 | Indemnity certificates / policy | | | | | 21 | Site Agreements | Model clinical trial agreements web link | | | | 22 | Research Account statements | | | | | 23 | Invoices | | | | | 24 | Finance correspondance with sites | | | | | 25 | Other finance correspondence other than contracts | | | | | Ethics & MHRA | | | | | | 26 | EUDRACT number | EudraCT website | | | | 27 | HRA correspondence | weblink to HRA Approval info page | | | | 28 | Adoption onto the NIHR portfolio | | | | | 29 | Ethics application including correspondence | web link to REC approval information | | SOP005 | | 30 | Favourable Ethical Approval letter | | | | | 31 | MHRA application including correspondence | web link for gaining MHRA approval information | | SOP014 | | 32 | Clinical Trial Authorisation letter | | | | | 33 | Copy of the Annual Progress Report(s) to Ethics | HRA website link giving up-to-date information | | | | 34 | Copy of the end of trial notification form and report sent to Ethics & MHRA | | | | | Amendments | | | | | GD004: Sponsor File Index with hyperlinks Version 1.0 Review Date: January 2019 Page 2 of 6 Trial Master File Index with hyperlinks to templates | 35 | Amendments to ethical approval a separate bundle of documents filed in chronological order for each amendment comprising copies of:
1) all the amended documentation
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 | | --- | --- | --- | --- | --- | | 36 | Correspondence regarding the amendment | | | | | Pharmacovigilence | | | | | | 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

FAQs

What is included in the essential Trial Master File section?

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.

How does the index organize sponsorship, approvals, and ethics material?

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.

Which pharmacovigilance and safety documents are listed?

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.

Sep 12, 2026

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