Preparation of trial archive

SOP Studiearkiv (Trial archive)

Trial Master File (TMF)
For multicentre trials:

Each sponsor must have a TMF (see Template Trial Master File, Table of contents, Multicentre Study)
Template TMF index divider, Multicentre Study

The following are various templates to be used in the TMF itself:
Template Informed Consent Form Tracking Log
Template Protocol Version Tracking Log
Template Contact Information Study Team
Template Meeting Participants
Template Laboratory Sample Storage

Investigator’s Site File (ISF)
Each participating centre must have an ISF (see Template Investigator’s Site File, Table of contents, Template ISF Index Divider and Template Location of Document if not in ISF)

The following are various templates to be used in the ISF itself:
Template Contact Information Study Team
Template Meeting Participants to document e.g. training
Template Prescreening Log
Template Screening Log which documents whether or not trial participants who have consented can be included in trials, and if not why not
Template Identification and Enrolment Log or code list with the full name of each trial participant
Template Laboratory Sample Storage
Template Source Data List which defines the sources of the data in the trial
Template Delegation of Tasks within the Study Team in which the principal investigator documents the delegation of tasks to other personnel at the centre
Template CV for the people on the delegation log. There is also a CV Template that can be used by trial personnel other than doctors.
Template Temperature Log to document that the investigational medicinal products have been stored in accordance with the correct temperature conditions.

An inventory must be kept of the investigational medicinal products. Below are three examples:

Mal legemiddelregnskap – lagerbeholdning, pakninger med ID-nummer (Template Drug accountability form – inventory, packs with ID numbers)

Mal legemiddelregnskap – lagerbeholdning, felles lager unummererte pakninger (Template Drug accountability form – inventory, shared inventory unnumbered packs)

Mal legemiddelregnskap – ikke lagerbeholdning, markedsført legemiddel varierende leverandør (Template Drug accountability form – not inventory, marketed medicinal product from varying suppliers)

If not using off-the-shelf pharmacy products, reconciliation and destruction must be documented.

Investigational Medicinal Product – Drug Reconciliation

Destruction of Investigational Medicinal Product

If the pharmacy is involved, a separate folder should be made (Mal Innholdsfortegnelse apotekperm (Template Contents pharmacy folder)), including some of the templates mentioned above. When the trial is over, completed templates and other documentation are to be placed back in the ISF.

Single-centre trials
For single-centre trials, Template TMF/ISF Table of Contents, Single Center Study and Template TMF/ISF Index Divider, Single Center Study can be used. In this case, all the templates mentioned above are relevant.