Viedoc-provided templates
The templates currently available for download are for non-device studies and device studies.
You can download the Viedoc Non-device template here.
You can download the Viedoc Device template here.
Introduction
The Viedoc-provided eTMF templates are baseline templates in Excel format that you can download and customize to cover your organization's needs.
The templates are of standard structure based on the Reference Model of the Drug Information Association (DIA), and are created according to best practices in Viedoc eTMF considering artifacts and the roles’ permissions to the artifacts.
The templates include artifacts that are meant to be used by the sponsor TMF and Investigator Site File (ISF). The Site staff role is intended to be assigned to Site personnel so that they can upload documents to the ISF. The other roles can be used for different purposes when working on the sponsor TMF.
How to use the Viedoc template
The template can be used off the shelf or with modifications to suit your study needs. Ensure that your approach is properly validated for your study. For further information on how to handle and use the templates, refer to the lessons around templates in Viedoc User Guide for eTMF Managers.