COUNTRY-LEVEL TRIAL MASTER FILE INDEX
EudraCT No:
Short Title:
Sponsor:
Country:

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
C1 / Country-Specific Protocol Amendments
C2 / Country-Specific Informed Consent/Assent and Advertisements
C3 / Country-Specific Data Collection Tools
C4 / Regulatory Approvals
C5 / Ethics Committee Approvals
C6 / Country-Specific Insurance/Indemnity
C7 / Clinical and Non-Clinical Supplies
C8 / Import/ Export Licences
C9 / Country-Specific General Correspondence
Section / Title
C1 / Country-Specific Protocol Amendments
Section / Title / ICH E6
Ref / Required
(Y/N)
C1.1 / Country-Specific Protocol Amendments with Sponsor Approval Signatures / 8.2.2
8.3.2
C1.2 / Translations
C1.2.1 / Document Review and Approval Forms / 8.2.2
C1.4 / Significant Correspondence / 8.3.11
Section / Title
C2 / Country-Specific Informed Consent/ Assent and Advertisements
Section / Title / ICH E6
Ref / Required
(Y/N)
C2.1 / Patient Information/ Informed Consent Form (ICF) / 8.2.3
8.3.2
C2.1.1 / Country-Specific Patient Information/ Informed Consent Form (ICF) with Sponsor Approval Signatures / 8.2.3
8.3.2
C2.1.2 / Translations / 8.2.3
8.3.2
C2.1.3 / Document Review and Approval Forms
C2.2 / Advertisement / 8.2.3
8.3.2
C2.2.1 / Country-Level Advertisement / 8.2.3
8.3.2
C2.1.2 / Translations / 8.2.3
8.3.2
C2.1.3 / Document Review and Approval Forms
C2.3 / Study Participation Cards
C2.4 / Significant Correspondence / 8.3.11
Section / Title
C3 / Country-Specific Data Collection Tools
Section / Title / ICH E6
Ref / Required
(Y/N)
C3.1 / Patient Diary/ Questionnaire / 8.2.3
C3.1.1 / Country-Specific Diaries/ Questionnaires / 8.2.3
8.3.2
C3.1.2 / Translations / 8.2.3
8.3.2
C3.1.3 / Document Review and Approval Forms
C3.2 / Country-Specific Amendments to Data Collections Tools / 8.3.2
C3.3 / Significant Correspondence / 8.3.11
Section / Title
C4 / Regulatory Approvals

Create additional sections as appropriate for more authorities following the conventions provided below.

Section / Title / ICH E6
Ref / Required
(Y/N)
C4.1 / Regulatory Authority Approvals / 8.2.9
C4.1.1 / Initial Submission / 8.2.9
C4.1.2 / Initial Approval / 8.2.9
C4.1.3 / Subsequent Submissions and Approvals / 8.3.4
C4.1.4 / Significant Correspondence / 8.3.11
C4.2 / Other Country-Specific Approvals and Agreements
C4.2.1 / Approvals
C4.2.2 / Significant Correspondence / 8.3.11
Section / Title
C5 / Ethics Committee Approvals

Create additional sections as appropriate for more committees following the conventions provided below.

Section / Title / ICH E6
Ref / Required
(Y/N)
C5.1 / Ethics Committee Approvals / 8.2.7
C5.1.1 / Contact Details for Central Ethics Committees (CEC)
C5.1.2 / CEC – Initial Submission / 8.2.7
C5.1.3 / CEC – Initial Approval
(Including GCP Compliance and Membership Lists) / 8.2.7
C5.1.4 / CEC – Subsequent Submissions and Approvals / 8.3.3
C5.1.5 / PIS/ Informed Consent Changes Requested or Approved by Ethics Committee(s) / 8.3.3
C5.1.6 / Significant Correspondence / 8.3.11
C5.2 / Other Country-Specific Approvals and Agreements
C5.2.1 / Approvals
C5.2.2 / Significant Correspondence / 8.3.11
Section / Title
C6 / Country-Specific Insurance/ Indemnity

Create additional sections as appropriate for more insurers, following conventions provided. Insurance certificates stored here should be country-level. Evidence of insurance ‘due diligence’ should be documented here i.e., evidence that the insurance policy has been reviewed to ensure that the clinical study patient population is covered by/ not excluded from, the insurance policy.

Replace blue highlighted text with appropriate text

Section / Title / ICH E6
Ref / Required
(Y/N)
C6.1 / Insurance 1 / 8.2.5
C6.1.1 / Current Certificates / 8.2.5
C6.1.2 / Previous Certificates / 8.2.5
C6.1.3 / Significant Correspondence / 8.3.11
C6.2 / Insurance 2 / 8.2.5
C6.2.1 / Current Certificates / 8.2.5
C6.2.2 / Previous Certificates / 8.2.5
C6.2.3 / Significant Correspondence / 8.3.11
Section / Title
C7 / Clinical and Non-Clinical Supplies
Section / Title / ICH E6
Ref / Required
(Y/N)
C7.1 / Regulatory Approval Requirement for Supplies / 5.14
C7.1.1 / Country-Specific Sponsor-Approved Regulatory Green Light Checklist for IMP Shipment / 5.14
C7.1.2 / Significant Correspondence / 8.3.11
Section / Title
C8 / Import/ Export Licenses
Section / Title / ICH E6
Ref / Required
(Y/N)
C8.1 / Import/ Export Licences
C8.2 / Significant Correspondence / 8.3.11
Section / Title
C9 / Country-Specific General Correspondence

This section should be used for any correspondence that does not directly impact ongoing trial 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 E6
Ref / Required
(Y/N)
C9.1 / Country-Specific General Correspondence / 8.3.11
Example of Country-level TMF Index / Page 1 of 10