TRIAL MASTER FILE (TMF)-Study LevelIndexv3.0

Multisite- Studies

TMF Location Details
SECTION / TITLE / Y/N / NOTES/
LOCATION
Table of Contents
Trial Master File – Filing Index
Study Summary Page
1. / General
1.1 / Correspondence /
  • Letters, Emails and General Correspondence

1.2 / Notes /
  • General and Hand over Notes

2. / Personnel
2.1 / Core Study Team /
  • Contact Details of CI and Core Study Team
  • Roles and Responsibilities
  • Core Study Team CV’s & GCP Certificates
  • CompletedTraining log
  • Completed Signature & Delegation Log
  • Confidentiality Agreements (where appropriate)

2.2 / Project Steering Group /
  • Name and Contact Details (if not above)
  • Roles and Responsibilities
  • Terms of Reference
  • Collaboration Agreements
  • Minutes of Meetings

3. / Sponsorship & Funding
3.1 / Sponsorship /
  • Written Letter/Agreement from Research Governance Sponsor
  • Details/contract of co-sponsorship or delegation of roles
  • Correspondence
  • Indemnity Arrangements
  • Indemnity Certificates for non-NHS co-sponsors

3.2 / Funding /
  • Written Agreement from Funding Body (where applicable)
  • Correspondence
  • Contract/Agreement

4. / Supplies
4.1 / Suppliers /
  • Contact Details
  • Contracts or Written Agreement
  • Correspondence
  • Procurement Arrangements
  • Financial Arrangements
  • Current QP Certificate of Analysis of IMP Shipped
  • MAIMP license of IMP supplier
  • Calibration Certificates

SECTION / TITLE / Y/N / NOTES/
LOCATION
5. / Central Services
5.1 / IMP/Intervention Management /
  • Details of Central Service (e.g. Pharmacy)
  • Written Agreement/Authorisation for Roles & Responsibilities
  • Licence/Accreditation Certificates
  • Sub-Contracts (where an external service)
  • CVs of Central Service Team
  • Financial Arrangements
  • Delegation/Authorisation Log
  • Intervention/IMP Shipping Log
  • Intervention/IMP Destruction Log
  • Record of Recalled Site Intervention/IMP
  • Training Logs
  • Temperature Log
  • Indemnity Certificates, if non-NHS

5.2 / Body Fluids/ Tissue /
  • Details of Central Service (e.g. Pathology)
  • Written Agreement/Authorisation for Roles & Responsibilities
  • Licence/Accreditation Certificates
  • NormalValueRanges(Lab, technical procedures or tests)
  • Sub-Contracts (wherean external service)
  • CVs of Central Service Team
  • Financial Arrangements
  • Delegation/Authorisation Log
  • Body Fluids/Tissue Accountability Log
  • Body Fluids/Tissue Shipping Log
  • Body Fluids/Tissue Destruction Log
  • Training Logs

5.3 / Other Services
(PET CT, CTU, CRO) /
  • Contact Details of Site Dept. Performing Service
  • Written Authorisations for Roles & Responsibilities
  • CVs of Site Service Teams & GCP Certificates
  • Current Site Service License and Accreditation Certificates (where applicable)
  • Record of All Scans/Tests at Site
  • Training Logs
  • Delegation/Authorisation, where appropriate

6. / Tissue Banks
6.1 / Tissue Banks /
  • Contact Information for Tissue Bank & DI
  • Material Transfer Agreement with Tissue Bank
  • Current License for Tissue Bank

7. / Protocol and Associated Study Documents
7.1. / Version Control /
  • Version Control Log of Approved Documents

7.2 / Protocol /
  • Current, Approved, Version: Signed by CI

7.3 / Correspondence Documents /
  • Current, Approved, Patient Information Sheet (Template)
  • Current, Approved, Consent Form (Template)
  • Current, Approved GP Letter
  • Current Approved Advertisements

7.4 / Data Collection Tools /
  • Questionnaires (Templates)
  • Case Report Form (s) (Template)

7.5 / Clinical Intervention/IMP /
  • Investigator Brochure (IB, SmPC, PI)
  • Product/devices manuel
  • CE Mark

7.6 / Other Documents /
  • Current, Approved, Version-Controlled Sample Label for Medical Records Showing Patients’ Involvement in the study

8. / Study Standard Operating Procedures (SOPS) and Template Logs
8.1 / Participant Logs /
  • Site Participant Screening Log (Template)
  • Site Participant Enrolment Log (Template)
  • Informed Consent Forms

8.2 / Study TeamLogs /
  • Delegation & Signature Log (Template)
  • Training Log (Template)

8.3 / Document Log /
  • Study Specific Documentation Log(Template)

8.4 / Intervention/IMPManagement SOPS /
  • Pharmacy SOPs
  • Recall SOP
  • Accountability Log (Template/s)
  • Destruction Log (Template/s)
  • Temperature Log (Template/s)
  • Approved, Version-Controlled Labels attached to product Container(s)(Sample)

8.5 / Bodily Fluids/ Tissue SOPS /
  • Study Laboratory Manual
  • Body Fluids/Tissue Sample Accountability Log (Template)
  • Body Fluids/Tissue Sample Shipping Log (Template)
  • Body Fluids/Tissue Sample Destruction Log (Template)

8.6 / Radiology SOPS /
  • Study Radiology Manual
  • Scan Request Forms or Labels (Templates)

8.7 / Safety SOPS /
  • Safety Reporting Procedure
  • AE/SAE Forms (Template)
  • AE Logs (Template)
  • Emergency Decoding/Unblinding Procedure

8.8 / Other Study SOPS /
  • Randomisation procedure

SECTION / TITLE / Y/N / NOTES/
LOCATION
9. / Approvals/Permissions
9.1 / MHRA /
  • Approval Letter/s
  • Clinical Trial Application (CTA)/IRAS
  • Annual Report

9.2 / REC /
  • Approval Letter/s
  • Main REC form/IRAS
  • Annual Report

9.3 / NHS Permission /
  • Main R&D Form/IRAS
  • Evidence of study-wide NHS Permissions (if applicable)
  • Governance Report(if applicable)
  • R&D Approval Letter

10. / Amendments
10.1 / Log /
  • Log of amendments and dates

10.2 / Amendment /
  • Amendment details filed in chronological order to include all paperwork submitted for regulatory approval
  • Correspondence to Investigator Sites of Amendments

11. / Monitoring
11.1 / Risk /
  • Sponsors Risk Assessment

11.2 / Site Initiation /close out /
  • Site Initiation Plan
  • Master Record of Site Initiation Visits/close out

11.3 / Monitoring /
  • Approved Monitoring Plan
  • Master Record of Site Monitoring Visits

11.4 / Data Safety Monitoring Committee /
  • Names and Contact Details
  • Roles and Responsibilities
  • DSM Charter
  • Summary of Key Issues/Actions

12. / Participant Recruitment
12.1 / Randomisation /
  • Master Randomisation List (blind maintained)
  • Master ID Code List (if appropriate)

12.2 / Participants /
  • Master Screening Record
  • Master Recruitment Record
  • Record of Source Data (where can it be found)

13. / Data Collection
13.1 / Records/Logs /
  • Master Records of Data Collected

SECTION / TITLE / Y/N / NOTES/
LOCATION
14. / Data Analysis
14.1 / Analytical Workings /
  • Summaries/Reports/Excel Spreadsheets
  • Data Review Meetings

15. / Safety Reports
15.1 / Annual Reports /
  • Record of Annual Safety Report(s) Due Date(s)
  • MHRA /REC Annual Safety Reports (DSURS)

15.2 / Master Reports /
  • AE Line Listing

15.3 / Notifications /
  • Notifications to and from Suppliers of Safety Information
  • Notifications to Investigator Sites of Safety Information

15.4 / Expedited Reports /
  • SUSAR Reports to MHRA and REC
  • SAE Reports to REC

16. / Finance
16.1 / Financial Records /
  • Study Cost Centre Details
  • Study Finance Schedule
  • Study Expenditure Plan
  • Study Invoices
  • Study Payments

17. / Superseded Documents
17.1 / Personnel /
  • Superseded Documents–Sections 2

17.2 / Sponsorship & Funding /
  • Superseded Documents – Section 3

17.3 / Collaborators /
  • Superseded Documents – Section 4

17.4 / Supplies /
  • Superseded Documents – Section 5

17.5 / Central Services /
  • Superseded Documents – Section 6

17.6 / Tissue Banks /
  • Superseded Documents – Section 7

17.7 / Protocol Documents /
  • Superseded Documents–Section 8

17.8 / SOPS & Logs /
  • Superseded Documents–Section 9

17.9 / Approvals /
  • Superseded Documents–Section 10

17.10 / Finance /
  • Superseded Documents–Section 15

17.11 / Other

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TMF Study LevelIndex: V3.0Jan 2012