SINGLE CENTRE
TRIAL MASTER FILE (TMF) / INVESTIGATOR SITE FILE (ISF):
Filing Index V3.0
TMF Location Details :
SECTION TITLE
Y/N
Table of Contents
Investigator Site File (ISF) Filing Index
Study Summary Page
TMF location log
1.
General Correspondence
1.1
Correspondence
 Site Specific Letters, Emails, Phone Records
and General Correspondence
1.2
Document Log
 Log of Documents Sent
 Record of Outstanding Actions at Site
1.3
Notes
 General Notes and Handover Notes
2.
Personnel
2.1
Contacts Summary
 Summary Sheet of Key Contacts at Site
 Daytime and ‘Out of Hours’ Contact Information
as Given to Participants
2.2
Study Team
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2.3
Project Steering
Group
2.4
Data Safety
Monitoring Committee
Single Centre ISF-TMF Filing Index v3 Feb 2012
Contact Details of CI
Roles and responsibilities
Study Team CV’s
Study Team GCP Certificates
Study Team Training Log
Signature and Delegation log
 Honorary Research Contracts/
Letters of Access (if applicable)
 Confidentiality Agreements (if applicable)
 Collaboration agreements (if applicable)
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 Name and Contact Details (if not above)
 Roles and Responsibilities
 Terms of Reference
 Minutes of Meetings
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 Name and Contact Details
 Roles and Responsibilities
 Terms of Reference
 DSM Charter
 Summary of Key Issues
1
NOTES/
LOCATION
SECTION TITLE
Y/N
3.
Sponsorship, Agreements & Funding
3.1
Sponsorship &
Agreements
 Written Letter/Agreement from Research
Governance Sponsor
 Details of Co-Sponsorship Arrangements or
Delegation of Roles (if applicable)
 Contractual Arrangements with Co-Sponsor
Organisations (if applicable)
 Signed (Clinical Trial) Agreement between
Sponsor & Site (if applicable)
 Indemnity Arrangements
 Indemnity Certificates for Non-NHS Organisations
 Signed Confidentiality Agreement between
Sponsor and Site (if applicable)
 Other Agreement with Sponsor (e.g. Material Transfer)
 Correspondence
3.2
Funding
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4.
Supplies
4.1
Suppliers
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LOCATION
Written Agreement from Funding Body
Grant award
Grant application
Correspondence
 Contact Details of Supplier/s
 Contracts or Written Agreement with Supplier/s
(Supply agreement)
 Procurement Arrangements
 Records of Receipt, Retention & Returns
 Current QP ‘Certificate of Analysis’ for shipped
IMP/product
 Marketing Authorisation IMP license for supplier of
IMP
 Calibration Certificates
 Indemnity Certificates if Applicable/Warrenty
4.2
General Equipment
and Supplies
5.
Services
5.1
IMP/Product/
Intervention
Management
Single Centre ISF-TMF Filing Index v3 Feb 2012
 Procurement details and order numbers
 Indemnity statement for equipment on loan
 Correspondence
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Details of Service
Written Authorisations for Roles & Responsibilities
Sub-Contracts (where an service is external)
Financial Agreements
Current Licence / Accreditation Certificates
CVs, GCP & Training Certificates
Training Logs
2
Maybe on
SSIF (e.g.
Pharmacy)
SECTION TITLE
5.1
Product/IMP Services
continued
6.
Services
6.2
Body Fluids/Tissue
(if applicable)
6.3
Site Tissue Bank
(if applicable)
Y/N
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Signature & Delegation Log (if separate log required)
IMP/product Accountability log
Product / IMP Shipping Log (if applicable)
Product/ IMP Destruction Log (if applicable)
Temperature Logs (if applicable)
Record of Recalled Site Product / IMP
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Contact Details of Service
Written Authorisations for Roles & Responsibilities
Sub-Contracts/MTA (where service is external)
Financial Arrangements
Current License and Accreditation Certificates
Current Normal Value Ranges
Signature & Delegation Log (if separate log required)
CVs, GCP & Training Certificates
Training Logs
Body Fluids/Tissue Accountability Log
Body Fluids/Tissue Shipping Log (if applicable)
Body Fluids/Tissue Destruction Log (if applicable)
 Contact Details of Service
 Written Authorisations for Roles & Responsibilities
 Sub-Contracts (where service is external)
 CVs, GCP & Training Certificates
 Training Logs
 Current License and Accreditation Certificates
 ARSAC certificates
 IRMER approvals
 Record of All Scans/Tests at Site
 Signature & Delegation Log (if separate log required)
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Other Services
(e.g. PET)
7.
Protocol and Associated Study Documents
7.1
7.2
Version Control
Protocol
 Record of Approved Documents
 Current, Approved Version: Signed by CI & PI
 Randomisation procedure
7.3
Correspondence
Documents
(Templates &
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Single Centre ISF-TMF Filing Index v3 Feb 2012
Maybe on
SSIF (e.g.
Pathology)
 Contact Information for Tissue Bank & DI
 Material Transfer Agreement (if external)
 Current License for Tissue Bank
6.4
Localised Versions)
NOTES/
LOCATION
Current Participant Information Sheet
Current Consent Form
Current GP Letter
Current Advertisements
Other Approved Correspondence Documents
3
Maybe on
SSIF
(e.g. PET,
Radiology)
SECTION TITLE
Y/N
7.4
Data Collection Tools
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Questionnaires
Case Report Forms (CRFS)
7.5
Product/ Intervention
/ IMP (if applicable)
7.6
Other Documents
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Latest Investigator Brochure (IB, SmPC, PI)
CE Mark
Devices product manual
Current, Approved, Version-Controlled Sample
Label for Medical Records Showing Patients’
Involvement in the Study
8.
Standard Operating Procedures (SOPS) and Template Logs
8.1
Participant Logs
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Site Participant Screening Log (Template)
Site Participant Enrolment Log (Template)
8.2
Study Team Logs
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Delegation & Authorisation Log (Template)
Training Log (Template)
8.3
Product/Intervention /
IMP SOPS
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Manuals and SOPS
Approved, version-controlled labels attached to
Pharmacy SOPs
Sample Logs
8.4
Bodily Fluids / Tissue
SOPS
Study Laboratory Manual
Sample Logs
Sample labels for Pathology Tests
Pathology SOPS
8.5
Radiology SOPS
8.6
Safety SOPS
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8.7
Other Study SOPS
9.
Regulatory Approval
9.1
MHRA (CTIMPS &
Device Trials Only)
Site Radiology Manual
Scan Request Forms or Labels
Radiology SOPS
Study Safety Reporting Procedure
AE/SAE Forms
AE Logs
Emergency Decoding/Unblinding Procedure
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Approval Letter
Clinical Trial Application (CTA)/IRAS
Annual Report
9.2
REC
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Approval Letter
Main REC form / IRAS
Annual Report
9.3
NHS Permissions
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R&D Form (IRAS)
Conditions of Approval
Site Specific Information Form (SSIF)
Governance Report (if applicable)
Single Centre ISF-TMF Filing Index v3 Feb 2012
4
NOTES/
LOCATION
SECTION TITLE
Y/N
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Approval Letter
Main Form / IRAS
Annual Report
Risk
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Risk Assessment/s
10.2
Site Initiation
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Record of Site Initiation Visit/ checklist
Site Initiation Report
Correspondence/Follow-up Letters/Actions
10.3
Site Monitoring
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Approved Monitoring Plan
Record of Site Monitoring Visit
Monitoring Reports and Action Plan
Monitoring Action Log
Correspondence/Follow-up Letters
Site Close Out
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Record of Site Close Out Visit/ checklist
9.4
GTAC/OTHER
10.
Monitoring
10.1
11.
Participant Recruitment
11.1
Participants
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11.2
Randomisation
 Master Randomisation list (Blind maintained)
 Master ID code list (if appropriate)
12.
Data Collection
12.1
Records/Logs
12.2
Data Analysis
13.
Safety Reports
13.1
Reports
13.2
Annual Reports
13.3
13.4
Master Reports
Expedited Reports
13.5
Notifications
Single Centre ISF-TMF Filing Index v3 Feb 2012
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Participant Screening Log
Participant Recruitment Log
Participant ID Code List
Participant Transfer Records
Participant Consent Forms
Record of source data (where it can be found)
Completed Data Collection Forms (CRF’S)
Analytical workings
Summary reports
Excel spreadsheets
Notes
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SAE/SSAR/SUSAR Initial Reports
SAE/SUSAR Follow-Up Reports
Correspondence
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Record of Annual Safety Report(s) Due Date(s)
MHRA /REC Annual Safety Reports (DSURS)
AE Line Listing
SUSAR Reports to MHRA and REC
SAE Reports to REC
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Safety notifications to & from Suppliers
5
NOTES/
LOCATION
SECTION
TITLE
14.
Finance
14.1
Financial Records
15.
Amendments
15.1
Y/N
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Study Finance Schedule
Expenditure Plan
Invoices
Payment Records
Study cost centre details
Log
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Log of Amendments and Dates
15.2
Amendments

Amendment Details Filed in Chronological
Order to Include all Paperwork Submitted for
Regulatory Approval
16.
Superseded Documents
16.1
16.2
16.3
16.4
Project Management
Personnel
Protocol Documents
Sponsorship &
Funding
SOPS & Logs
Regulatory
Approvals
Site Services
Finance
Other
16.5
16.6
16.7
16.8
16.9
Single Centre ISF-TMF Filing Index v3 Feb 2012
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Superseded Documents–Section 2
Superseded Documents - Section
Superseded Documents – Section 3
Superseded Documents – Section
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Superseded Documents–Section 4
Superseded Documents–Section 5
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Superseded Documents–Section 7
Superseded Documents–Section 11
6
NOTES/
LOCATION