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Please REMOVE blue italic guidance text when setting up the TMF.
Links to the relevant sections of Section 8 of ICH E6 have been provided for each of the subsections with a view to enabling quick reference to the requirements listed in this key guidance document.
Section / Title /S1 / Protocol and Amendments
S2 / Investigator Brochure/Product Information
S3 / Site-Specific Informed Consent/Assent and Advertisements
S4 / Site-Specific Data Collection Tools
S5 / Ethics Committee Approvals
S6 / Site-Specific Agreements and Approvals
S7 / Principal Investigator/Trial Site-related Information
S8 / Clinical Monitoring
S9 / Clinical and Non-Clinical Supplies
S10 / Safety
S11 / Local Laboratory Documentation
S12 / Site-Specific General Correspondence
Section / Title
S1 / Protocol and Amendments
Section / Title / ICH E6
Ref / Required
(Y/N)
S1.1 / Final Protocol Signature Pages with Principal Investigator (PI) Approval Signatures / 8.2.2
S1.2 / Protocol Amendments with Signature Pages with PI Approval Signatures / 8.2.2
8.3.2
S1.3 / Significant Correspondence / 8.3.11
Section / Title
S2 / Investigator Brochure/ Product Information
Section / Title / ICH E6
Ref / Required
(Y/N)
S2.1 / Investigator Brochure (IB) and IB Update Receipts / 8.2.1
8.3.1
S2.3 / Significant Correspondence / 8.3.11
Section / Title
S3 / Site-Specific Informed Consent/ Assent and Advertisements
Section / Title / ICH E6
Ref / Required
(Y/N)
S3.1 / Site-Specific Patient Information/ Informed Consent Forms (ICF) and amendments / 8.2.3
8.3.2
S3.2 / Advertisement Used / 8.2.3
8.3.2
S3.3 / Patient Emergency Contact Card
S3.4 / Significant Correspondence / 8.3.11
Section / Title
S4 / Site-Specific Data Collection Tools
Section / Title / ICH E6
Ref / Required
(Y/N)
S4.1 / Site-Specific Patient Diaries/ Questionnaires / 8.2.3
8.3.2
S4.2 / Site-Specific Amendments to Data Collections Tools / 8.3.2
8.3.2
S4.3 / Significant Correspondence / 8.3.11
Section / Title
S5 / Ethics Committee Approvals
Note – Original documents should be stored in the Investigator Site File (Refer to Attachment D of CR-S-005)
Section / Title / ICH E6Ref / Required
(Y/N)
S5.1 / Ethics Committee Approvals (Copy) / 8.2.7
S5.1.1 / Contact Details for Local Ethics Committees (LEC)
S5.1.2 / LEC – Initial Submission / 8.2.7
S5.1.3 / LEC – Initial Approval
(Including GCP Compliance and Membership Lists) / 8.2.7
S5.1.4 / LEC – Subsequent Submissions and Approvals / 8.3.3
S5.1.5 / LEC – Periodic Updates
(such as annual status reports) / 8.3.3
S5.1.6 / End of Study Notifications
(May be captured here or in the country-level index) / 8.4.7
S5.1.7 / PIS/ Informed Consent Changes Requested or Approved by LEC(s) / 8.3.3
S5.1.8 / Significant Correspondence / 8.3.11
Section / Title
S6 / Site-Specific Agreements and Approvals
Add to subsections as necessary, using numbering conventions provided.
Section / Title / ICH E6Ref / Required
(Y/N)
S6.1 / Site-Specific Agreements and Approvals / 8.2.6
8.2.4
S6.1.1 / Investigator Agreements and Financial Aspects
(For example, the mCTA in the UK) / 8.2.6
8.2.4
S6.1.2 / Financial Agreement Approved by the Hospital Administration / 8.2.6
8.2.4
S6.1.3 / Significant Correspondence / 8.3.11
Section / Title
S7 / Principle Investigator/ Study Site-Related Information
Section / Title / ICH E6
Ref / Required
(Y/N)
S7.1 / Site Contact Details
S7.2 / Site Delegation/ Signature Log / 8.3.24
S7.3 / Site Personnel CVs / 8.2.10
8.3.5
S7.4 / Patient Recruitment Logs
S7.5 / Screening & Enrolment Logs / 8.3.20
8.3.22
S7.6 / Financial Disclosure
S7.7 / FDA 1572 (If applicable)
S7.8 / Significant Correspondence / 8.3.11
Section / Title
S8 / Clinical Monitoring
Section / Title / ICH E6
Ref / Required
(Y/N)
S8.1 / Monitoring Visit Log
(File in-house at end of study) / 5.18.3
S8.2 / Visit Reports
S8.2.1 / Pre-Study Visit Report / 8.2.19
S8.2.2 / Site Initiation Visit Report / 8.2.20
S8.2.3 / Monitoring Visit Reports / 8.3.10
S8.2.4 / Site Close-Out Visit Report / 8.4.5
S8.3 / Significant Correspondence / 8.3.11
Section / Title
S9 / Clinical and Non-Clinical Supplies
Section / Title / ICH E6
Ref / Required
(Y/N)
S9.1 / Instructions for Handling Investigational Medicinal Products (IMPs) / 8.2.14
S9.2 / Site-Level Shipment Forms / 8.2.15
8.3.8
S9.3 / Study-Level IMP Accountability / 8.3.23
S9.4 / Destruction of Supplies / 8.4.2
S9.4.1 / Site-Level Destruction Documentation / 8.4.2
S9.4.2 / Destruction Confirmation / 8.4.2
S9.5 / Unblinding / 8.2.17
S9.5.1 / Decoding Procedure and Envelopes / 8.2.17
S9.6 / Significant IMP-Related Correspondence / 8.3.11
S9.7 / Site-Specific Non-Clinical Supplies Provided / 8.2.18
S9.8 / Significant Correspondence / 8.3.11
Section / Title
S10 / Safety
Section / Title / ICH E6
Ref / Required
(Y/N)
S10.1 / Serious Adverse Event (SAE) Reporting / 8.3.16
S10.1.1 / SAE Reporting Guidelines / 8.3.16
S10.1.2 / Blank SAE Form / 8.3.16
S10.1.3 / Completed SAE Forms / 8.3.16
S10.2 / Notifications from Investigators to Ethics Committees / 8.3.17
S10.3 / Notifications to Investigators of SAEs not at this Site / 8.3.18
S10.4 / Significant Correspondence / 8.3.11
Section / Title
S11 / Local Laboratory Documentation
Replace blue highlighted text with appropriate text. This section should contain full details of only the local laboratotory(ies). Details of the central laboratory(ies) should be placed in the Project-Level section of the TMF.
Section / Title / ICH E6Ref / Required
(Y/N)
S11.1 / Log of all Local Laboratories Including Contact Details
S11.2 / Local Laboratory A / 8.2.12
8.3.7
S11.2.1 / Contact Details
S11.2.2 / Local Lab Certification/ Accreditation / 8.2.12
8.3.7
S11.2.3 / Local Lab Current Reference Ranges / 8.2.11
8.3.6
S11.2.4 / Local Lab Superseded Reference Ranges / 8.2.11
8.3.6
S11.2.5 / Laboratory Manuals / 8.2.12
8.3.7
S11.2.6 / Local-Level Data Transfer Details / 8.2.12
8.3.7
S11.2.7 / Record of Retained Body Fluids/ Tissue Samples (if any) / 8.3.25
S11.2.8 / Significant Correspondence / 8.3.11
Section / Title
S12 / Site-Specific General Correspondence
This section should be used for any correspondence that does not directly impact ongoing study activities. Any correspondence that has an impact on day to day processing should be stored under the significant correspondence section of the relevant part of the TMF.
Section / Title / ICH E6Ref / Required
(Y/N)
S12.1 / Site-Specific General Correspondence / 8.3.11
Site-level TMF Example / Page 13 of 13