TABLE OF CONTENT TRIAL MASTER FILE (TMF) – MULTICENTER STUDY
Location of the original or validated copy / Paper TMF / eTMF / Other, specify.
SECTION 1:STUDY PROTOCOL
1.1Protocol Version Tracking Log
1.2 Current Study Protocol, Amendment and Protocol Signature Page
1.2.1 Current Protocol Signature Page signed by each PI
(if not included in the protocol)
1.3 Previous Study Protocol, Amendment(s) and Protocol Signature Page(s)
1.3.1 Previous Protocol Signature Page signed by each PI
(if not included in the protocol)
1.4 Risk Assessment
SECTION 2:INVESTIGATOR’S BROCHURE (IB)/SmPC
2.1 Current Version of IB/SmPC
2.2 Previous Version(s) of IB/SmPC
SECTION 3:SUBJECT INFORMATION
3.1 Informed Consent Form Version Tracking Log
3.2 Current Approved Informed Consent Form
3.3 Revised Informed Consent Forms
3.4 Subject Screening Log (if appropriate)
3.4.1 Completed Screening Log Site ____
3.4.2 Completed Screening Log Site ____
3.4.3 Completed Screening Log Site ____
3.5 Study Participation Cards/Subject Diary (if used)
3.6 Study Website and Referral Letters
SECTION 4:SAFETY UPDATES AND REPORTING
4.1 Instructions for Completion of Serious Adverse Events (SAE) Forms and Reporting
4.2 Blank SAE form
4.3 Completed SAE forms and Related Correspondence with Sites
4.4 Blank CIOMS form
4.5 Completed Suspected Unexpected Serious Adverse Reactions (SUSAR) /CIOMS reports and Related Correspondence with Regulatory Authority (SLV) if blinded
4.6 Annual Safety Reports
4.7 Data Monitoring Committee, if applicable
SECTION 5:STUDY SITE PERSONNEL AND AGREEMENTS
5.1 Contact List Study Team
5.1.1 Contact List Study Team Site ____
5.1.2 Contact List Study Team Site ____
5.1.3 Contact List Study Team Site ____
5.2 Delegation of Study Team Tasks
5.2.1 Completed Delegation of Study Team Tasks Site ____
5.2.2 Completed Delegation of Study Team Tasks Site ____
5.2.3 Completed Delegation of Study Team Tasks Site ____
5.3 CV of Study Team and Trial Training Documentation
(ICH GCP Training, Protocol-related Training)
5.3.1 CV and Training Documentation Site _____
5.3.2 CV and Training Documentation Site _____
5.3.3 CV and Training Documentation Site _____
5.4 Insurance Statement(s) (For Norway: LAF)
5.5 Agreements with Sites and External Vendors (confidentiality, financial, publication etc.)
SECTION 6:REGULATORY DOCUMENTS AND INTERNAL APPROVALS
Independent Ethics Committee (IEC)(REK)
6.1 Approvals - Protocol and Informed Consent Forms incl. Amendments
6.2 Initial Application Forms and Submission of Amendments
6.3 Submission of Final Study Report and Other Study Correspondence
6.4 Membership List of the Independent Ethics Committee
Regulatory Authority (RA)(SLV)
6.5 Approvals - Protocol incl. Amendments
6.6 Initial Application Forms and Submission of Amendments
6.7 Submission Annual Report, Final Study Report and Other Study Correspondence
InternalApprovals
6.8 Internal approval
SECTION 7:INVESTIGATIONAL MEDICINAL PRODUCT (IMP)
7.1 Expiry Update and Labeling Documentation
7.2 Emergency Unblinding Tools (if applicable)
7.3 Investigational Medicinal Product (IMP) Procedures
(reception, handling, storage, destruction)
7.4 IMP Miscellaneous
7.5 Master Randomization List (if applicable)
7.6 Certificate of Analysis (if applicable)
Storage and Accountability Depot: ______
7.7 Shipping Records for IMP
7.8 Return of Study Drug and Destruction Note
7.9 Drug Storage Documents
Storage and Accountability Site: ______
7.10 Shipping Records for IMP
7.11 Study Drug Accountability Records
7.12 Drug Storage Documents
7.13 Return of Study Drug and Destruction Note
Storage and Accountability Site: ______
7.14 Shipping Records for IMP
7.15 Study Drug Accountability Records
7.16 Drug Storage Documents
7.17 Return of Study Drug and Destruction Note
Storage and Accountability Site: ______
7.18 Shipping Records for IMP
7.19 Study Drug Accountability Records
7.20 Drug Storage Documents
7.21 Return of Study Drug and Destruction Note
SECTION 8:LABORATORY DOCUMENTS/TECHNICAL PROCEDURES8.1 Instructions for Sampling, Labeling, Storage and Shipment
8.2 Instructions for Other Technical Procedures
Central Laboratory Name of Lab :______
8.3Reference Values or Ranges
8.4Record of Retained Body Fluids/Tissue Sampling (if any)
8.5Certification, Accreditation or Other Validation
Local Laboratory Site :______
8.6Reference Values or Ranges
8.7Record of Retained Body Fluids/Tissue Sampling (if any)
8.8Certification, Accreditation or Other Validation
Local Laboratory Site :______
8.9 Reference Values or Ranges
8.10 Record of Retained Body Fluids/Tissue Sampling (if any)
8.11 Certification, Accreditation or Other Validation
Local Laboratory Site :______
8.12 Reference Values or Ranges
8.13 Record of Retained Body Fluids/Tissue Sampling (if any)
8.14 Certification, Accreditation or Other Validation
SECTION 9:MONITORING DOCUMENTATION
9.1 Monitoring Plan
9.2 General Note to File (not site specific)
Monitoring Site:______
9.3 Monitoring Log
9.4 Pre-Trial Monitoring Report, Initiation, Monitoring and Final Trial Close Out Reports
9.5 Site Visit Follow Up Letters and Other Relevant Correspondence
Monitoring Site:______
9.6 Monitoring Log
9.7 Pre-Trial Monitoring Report, Initiation, Monitoring and Final Trial Close Out Reports
9.8 Site Visit Follow Up Letters and Other Relevant Correspondence
Monitoring Site:______
9.9 Monitoring Log
9.10 Pre-Trial Monitoring Report, Initiation, Monitoring and Final Trial Close Out Reports
9.11 Site Visit Follow Up Letters and Other Relevant Correspondence
SECTION 10:CASE REPORT FORMS 10.1 User guidelines for completion of Case Report Forms
10.2 Sample of Case Report Forms (CRFs)
10.3 Original Completed Case Report Forms (CRFs) Site:______
10.4 Original Completed Case Report Forms (CRFs) Site:______
10.5 Original Completed Case Report Forms (CRFs) Site:______
SECTION 11:MEETINGS & CORRESPONDENCE
11.1 Newsletters
11.2 Non-site specific meetings
11.3 Other Correspondence with Sites and External Vendors
Meeting and CorrespondenceSite:______
11.4 Investigator Meetings Agenda and Minutes (incl. attendance list)
11.5 Other Meetings Agenda and Minutes (incl. attendance list)
11.6 Other Correspondence with Site
Meeting and CorrespondenceSite:______
11.7 Investigator Meetings Agenda and Minutes (incl. attendance list)
11.8 Other Meetings Agenda and Minutes (incl. attendance list)
11.9 Other Correspondence with Site
Meeting and CorrespondenceSite:______
11.10 Investigator Meetings Agenda and Minutes (incl. attendance list)
11.11 Other Meetings Agenda and Minutes (incl. attendance list)
11.12 Other Correspondence with Site
SECTION 12: DATA MANAGEMENT
12.1 Data Management Plan
12.2 Data Management Report
12.3 Database Lock Documentation
SECTION 13:STATISTCS13.1 Statistical Analysis Plan
SECTION 14:STUDY RESULTS
14.1 Final Clinical Study Report and Any Amendments
SECTION 15:ARCHIVING15.1 Delegation of Archiving
15.2 Archiving Location (for All Sites)
SECTION 16:MISCELLANEOUS (e.g. study specific procedures, correspondence with vendors/third parties)16.1 Miscellaneous

If documents are filed elsewhere during the study, file a "Location of document" statement in the corresponding section.

To be completed before archiving:

The paper TMF and the electronic TMF have been reviewed and validated. Together they represent a complete TMF for <enter study name>, <eudract number>.

Name of responsible personDate

Doc.no.2.5.1, Valid from June 2017 Only electronic version is valid. Page 1of5