TRIAL MASTER FILE (TMF) - Site LevelIndexv3.0

Multi-site Studies

TMF Location Details
SECTION / TITLE / Y/N / NOTES/
LOCATION
Table of Contents
TMF Site Level Filing Index
Study Summary Page (To include Site Details)
1. / General Correspondence
1.1 / Correspondence /
  • Letters, Emails and General Correspondence

1.2 / Notes /
  • General Notes
  • Log of Documents Sent to Site
  • Log of Outstanding Actions for Sites

2. / Personnel
2.1 / Contacts Summary /
  • Summary Sheet of Key Contacts at Site
  • Daytime and ‘Out of Hours’ Contact Information Given to Participants at Site

2.2 / Site Study Team /
  • Contact Details of PI and Site Study Team
  • Roles and Responsibilities
  • Site Study Team CV’s
  • Site Study Team GCP Certificates
  • Site Study Team Training Log
  • Honorary Research Contracts/Letters of Access(if appropriate)
  • Copy of site signature and delegation log
/ E.g. SSIF
3. / Sponsorship & Funding
3.1 / Sponsorship /
  • Signed (Clinical Trial) Agreement between Sponsor and Site
  • Signed Confidentiality Agreement between Sponsor and Site (if appropriate)
  • Other Agreements (e.g. Material Transfer)

4. / Site Services
4.1 / Subcontracted Service/s /
  • Contact information
  • Subcontract
  • Indemnity Certificate/s

4.2 / Subsidiary Sites /
  • Contact Information
  • Written Confirmation of Sub. Site Authorisation and contractual arrangements with Investigator Site

4.3 / Site Tissue Bank /
  • Contact Information for Site Tissue Bank & DI
  • Material Transfer Agreement with Site
  • Current Site License for Tissue Bank

SECTION / TITLE / Y/N / NOTES/
LOCATION
4.4 / IMP/Intervention Management /
  • Contact Details of Site Service receiving and managing the Intervention/IMP (e.g. Pharmacy)
  • Written Authorisations for Roles & Responsibilities
  • CVs of Site Service Teams & GCP Certificates
  • Current Site Service License and Accreditation Certificates(where applicable)
/ E.g. SSIF
4.5 / Body Fluids/Tissue /
  • Contact Details of Site Service processing Body Fluids/Tissue (e.g. Pathology)
  • Written Authorisations for Roles & Responsibilities
  • CVs of Site Service Teams & GCP Certificates
  • Current Site Service License and Accreditation Certificates (where applicable)
  • CurrentSiteServiceNormalValueRanges (Labs, Technical Procedures or Tests)

4.6 / Other Services /
  • Contact Details of Site Service Performing Scans/Tests (e.g. Radiology)
  • Written Authorisations for Roles & Responsibilities
  • CVs of Site Service Teams & GCP Certificates
  • Current Site Service License and Accreditation Certificates (where applicable)

5. / Protocol and Associated Study Documents
5.1 / Protocol /
  • Current, Approved Protocol Signature Page, Signed by PI
  • Evidence of Investigator Brochure Receipt

6. / Site Specific Standard Operating Procedures (SOPS)/Logs
6.1 / Site Specific SOPS /
  • Any Site SOPS or Logs to be used in place of Study SOPS

7. / Approvals/Permissions
7.1 / MHRA /
  • Approval Letter for Site

7.2 / REC /
  • Approval Letter for Site

7.3 / NHS Permissions /
  • Full Approval Letter for Site
  • Conditions of Approval
  • Site Specific Information Form (SSIF)

7.4 / GTAC/OTHER /
  • Approval Letter

SECTION / TITLE / Y/N / NOTES/
LOCATION
8. / Amendments
8.1 / Log /
  • Log of amendments and dates

8.2 / Amendment /
  • Amendment details filed in chronological order to include all paperwork submitted for regulatory approval

9. / Monitoring
9.1 / Site Initiation /
  • Record of Site Initiation Visit
  • Site Initiation Report/Checklist
  • Correspondence/Follow-up Letters/Actions

9.2 / Site Monitoring /
  • Record of Site Monitoring Visit
  • Monitoring Reports to Site and Action Plan
  • Monitoring Action Log for Site
  • Site Close Out Record
  • Correspondence/Follow-up Letters

10. / Participant Recruitment
10.1 / Participants /
  • Copies of Participant Site Screening Log
  • Copies of Participant Site Recruitment Log
  • Copies of Participant Transfer Records from Site
/ E.g. ISF
11. / Data Collection
11.1 / Records/Logs /
  • Copies of Completed Data Collection Forms from Site

12. / Safety Reports
12.1 / Reports /
  • AE Line Listing for Site
  • SAE/SSAR/SUSAR Initial Reports from Site
  • SAE/SUSAR Follow-Up Reports from Site
  • Correspondence

13. / Finance
13.1 / Financial Records /
  • Site Finance Schedule
  • Site Invoices
  • Site Payment Records

SECTION / TITLE / Y/N / NOTES/
LOCATION
14. / Superseded Documents
14.1 / Personnel /
  • Superseded Documents–Section 2

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

14.2 / Site Services /
  • Superseded Documents–Section 4

14.4 / SOPS /
  • Superseded Documents – Section 6

14.5 / Approvals /
  • Superseded Documents–Section 7

14.6 / Finance /
  • Superseded Documents–Section 10

14.7 / Other

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TMF Site -Level Index: v 3.0 Jan 2012