CT-Study Files planning phase

At the start of the study, please see CT SOP Study Files, point 4.2.

Each study centre must have a study archive. The content of the study archive depends on whether you are the sponsor site or not.

The Sponsor will assemble a study archive, a Trial Master File (TMF).

The contents of a TMF depend on whether the study is a multicenter or a single center study. If it is a Multicenter study then the sponsor needs both a TMF and an Investigator’s Site File (ISF), while each participating site has an ISF. If, however, it is a Single center study, then the sponsor only needs a combined TMF/ISF.

For documents stored elsewhere, document the location in the study files by using Location Of Document if not in ISF.

Multicentre study
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0.0          Trial Master File (TMF) Table of Content Multicenter Trial
0.0           Template TMF Multicenter Study Index Divider
 
1.1          Screening Log (sent from site)
1.4          Delegation log (sent from site)
1.5          Contact Information (sent from site)
1.6          Investigator Curriculum Vitae / CV for Non-investigators (sent from site)
1.7          IMP Temperature Log (sent from site)
1.7          IMP Accountability Form with Kit or ID-number or IMP Accountability Form Common Stock Unnumbered or IMP Accountability Form Different Manufacturers (sent from site)
1.9          Start-up Meeting Agenda
1.11        Source Data List (sent from site)
1.12        Laboratory Sample Storage Log (sent from site), if applicable
1.15        Contact Information trial team
1.16        Investigator Curriculum Vitae / CV for Non-investigators for study team
1.17       Risk Assessment Template / Risk Assessment Plan
1.18        DMC charter
2.1          Protocol Version Tracking Log
2.2          Informed Consent Form Version Tracking Log
2.5          Agreement Multicentre Trial
2.5          Samarbeidsavtale apotek / Økonomisk avtale apotek, if applicable
2.6          DSUR, if applicable
2.6          Investigator’s Brochure Checklist / Investigator’s Brochure (IB) Template, if applicable

Single center study

0.0          TMF/ISF Table of Content Center Trial

0.0          TMF/ISF Index Divider Single Center Trial

1.1 Screening Log

1.3          Identification and Enrollment Log

1.4          Delegation log

1.5          Contact Information

1.6          Investigator Curriculum Vitae / CV for Non-investigators

1.7          IMP Temperature Log

1.7          IMP Accountability Form with Kit or ID-number or IMP Accountability Form Common Stock Unnumbered    or IMP Accountability Form Different Manufacturers (sent from site)

1.7          IMP Requisition

1.7          IMP Destruction, if applicable

1.9          Start-up Meeting Agenda

1.10        Clinical Trial Protocol Site Signature Form

1.11        Source Data List

1.12        Laboratory Sample Storage Log, if applicable

1.15        Contact Information trial team

1.16        Investigator Curriculum Vitae / CV for Non-investigators study team

1.17        Risk Assessment Template / Risk Assessment Plan

1.18        DMC charter

2.1          Protocol Version Tracking Log

2.2          Informed Consent Form Version Tracking Log

2.5          Agreement Multicentre Trial

2.5          Samarbeidsavtale apotek / Økonomisk avtale apotek, if applicable

2.6          DSUR, if applicable

2.6          Investigator’s Brochure Checklist / Investigator’s Brochure (IB) Template, if applicable

Every study site part of a multicentre study must have an Investigator’s Site File (ISF)

0.0 Investigator’s Site File (ISF) Table of Content

0.0 ISF Index Divider

1.1 Screening Log

1.3          Identification and Enrollment Log

1.4          Delegation log

1.5          Contact Information

1.6          Investigator Curriculum Vitae / CV for Non-investigators

1.7          IMP Temperature Log

1.7          IMP Accountability Form with Kit or ID-number or IMP Accountability Form Common Stock Unnumbered    or IMP Accountability Form Different Manufacturers (sent from site)

1.7          IMP Requisition

1.7          IMP Destruction, if applicable

1.9          Start-up Meeting Agenda

1.10        Clinical Trial Protocol Site Signature Form

1.11        Source Data List (sent from site)

1.12        Laboratory Sample Storage Log (sent from site), if applicable

2.1          Protocol Version Tracking Log

2.2          Informed Consent Form Version Tracking Log

If a pharmacy will be involved, the Pharmacy File Table of Contents may be used.