Study Files planning phase
At the start of the study, please see 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.
Multicentre study
0.0 Template Trial Master File (TMF) Multicenter Study Table of Content
0.0 Template TMF Multicenter Study Index Divider
1.1 Template Protocol Version Tracking Log
1.4 Mal risikovurdering / Plan for risk assessment
2.1 Sjekkliste Investigator’s Brochure (IB) / Template Investigator’s Brochure (IB), if applicable
3.1 Template Informed Consent Form Tracking Log
3.4 Mal prescreening logg / Template Prescreening Log, if applicable
3.4 Mal Screening Log / Template Screening Log
5.1 Mal kontaktinformasjon studiegruppen / Template Contact Information Study Team
5.2 Mal delegeringslogg / Template Delegation of Tasks within the Study Team
5.3 Mal CV / Template CV for investigators. CV mal / CV Template for non-medical staff
5.5 Mal avtale multisenterstudie / Template Study Agreement Multicenter Study, if applicable
5.5 Mal samarbeidsavtale apotek / Mal økonomisk avtale apotek, if applicable
6.7 Template DSUR, if applicable
7.3 Mal temperaturlogg / Temperature Log
7.3 Mal legemiddelregnskap/Drug accountability form – lagerbeholdning, pakninger med ID-nummer or
8.1 Template Laboratory Sample Storage Log, if applicable
9.2 Mal kildedataliste/ Template Source Data List
Single center study
0.0 Vedl. LM 2.09.05 Template TMF/ISF Single Center Study Table of Content
0.0 Vedl. LM 2.09.06 Template TMF/ISF Single Center Study Index Divider
1.1 Template Protocol Version Tracking Log
1.4 Mal risikovurdering / Plan for risk assessment
2.1 Sjekkliste Investigator’s Brochure (IB) / Template Investigator’s Brochure (IB), if applicable
3.1 Template Informed Consent Form Tracking Log
3.4 Mal prescreening logg / Template Prescreening Log, if applicable
3.4 Mal Screening Log / Template Screening Log
3.7 Mal deltagerliste inkluderte forsøkspersoner / Template Identification and Enrollment Log
5.1 Mal kontaktinformasjon studiegruppen / Template Contact Information Study Team
5.2 Mal delegeringslogg / Template Delegation of Tasks within the Study Team
5.3 Mal CV / Template CV for investigators. CV mal / CV Template for non-medical staff
5.5 Mal avtale multisenterstudie / Template Study Agreement Multicenter Study, if applicable
5.5 Mal samarbeidsavtale apotek / Mal økonomisk avtale apotek, if applicable
6.7 Template DSUR, if applicable
7.3 Mal temperaturlogg / Temperature Log
7.3 Mal legemiddelregnskap/Drug accountability form – lagerbeholdning, pakninger med ID-nummer or
7.3 Mal destruksjonslogg/Destruction of Investigational Medicinal Product, if applicable
8.1 Template Laboratory Sample Storage Log, if applicable
9.2 Mal kildedataliste/ Template Source Data List
Every study site part of a multicentre study must have an Investigator’s Site File (ISF).
0.0 Template TMF/ISF Table of Content, Single Center Study
0.0 Template TMF/ISF Index Divider, Single Center Study
1.1 Template Protocol Version Tracking Log
3.1 Template Informed Consent Form Tracking Log
3.4 Mal prescreening logg / Template Prescreening Log, if applicable
3.4 Mal Screening Log / Template Screening Log
3.7 Mal deltagerliste inkluderte forsøkspersoner / Template Identification and Enrollment Log
5.1 Mal kontaktinformasjon studiegruppen / Template Contact Information Study Team
5.2 Mal delegeringslogg / Template Delegation of Tasks within the Study Team
5.3 Mal CV / Template CV for investigators. CV mal / CV Template for non-medical staff
7.3 Mal temperaturlogg / Temperature Log
7.3 Mal legemiddelregnskap/Drug accountability form – lagerbeholdning, pakninger med ID-nummer or
8.1 Template Laboratory Sample Storage Log, if applicable