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

7.3 Mal legemiddelregnskap/Drug accountability form – lagerbeholdning, felles lager unummererte     pakninger or

7.3 Mal legemiddelregnskap/Drug accountability form – ikke lagerbeholdning, markedsført legemiddel varierende leverandør

8.1 Template Laboratory Sample Storage Log, if applicable

9.2 Mal kildedataliste/ Template Source Data List

11.2 Mal agenda oppstartsmøte

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 legemiddelregnskap/Drug accountability form – lagerbeholdning, felles lager unummererte pakninger or

7.3 Mal legemiddelregnskap/Drug accountability form – ikke lagerbeholdning, markedsført legemiddel varierende leverandør

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

11.2 Mal agenda oppstartsmøte

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

7.3 Mal legemiddelregnskap/Drug accountability form – lagerbeholdning, felles lager unummererte     pakninger or

7.3 Mal legemiddelregnskap/Drug accountability form – ikke lagerbeholdning, markedsført legemiddel varierende leverandør

8.1 Template Laboratory Sample Storage Log, if applicable

9.2 Mal kildedataliste/ Template Source Data List

11.2 Mal agenda oppstartsmøte