Customizing a template

  • Published by Viedoc System 2025-03-26
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Note! This page contains information and instructions for the new TMF user interface. If you are using the old interface, please go to the relevant user guides:

Want to browse more information for the new interface? Please go to the new TMF user guides:

Introduction

The TMF template file defines which zones, sections, and artifacts that your TMF will have. Furthermore, it defines the permissions associated with the TMF user roles.

The TMF template is implemented in an Excel file.

As a TMF Manager, you have the permission to import, select, instantiate, export, rename, and delete templates.

With your Viedoc TMF license, a baseline template is provided. This template is not intended to be used as it is, but to be adapted to your organization's needs. See Viedoc-provided templates for more information.

To access the templates in Viedoc TMF, in the left navigation menu, select to expand TMF Admin, and select the Templates page:

In Viedoc TMF, there are two types of templates:

  • Organization template - available for all studies within your organization
  • Study template - available only for the specific study

It is recommended that you adapt the TMF template to your specific documentation landscape. For example, you can customize, add, or delete zones, sections, and artifacts.

However, the following requirements must be fulfilled for Viedoc TMF to successfully validate the template:

  • The template must include nine sheets, in any order.
  • The sheet names must not be changed.
  • All columns in all sheets are mandatory, which means that they must be present. However, some columns can be left empty. For more information, see the following sub-sections.
  • Some columns must include specific values. For more information, see the following sub-sections.
  • All sheets must have the same number of rows, that is one row per artifact.

The V 3.2.1 sheet

This sheet is based on the TMF Reference Model. Zones, sections, and artifacts can be customized, added, and/or deleted.

These are the requirements for the columns:

Zone # Must be unique
Zone Name Must be unique
Section #

Must be unique

It consists of two digits that represent the zone number that the section belongs to, followed by a separator and the section number.
Section Name Must be unique within the zone
Artifact #

Must be unique

It consists of two digits that represent the zone number, followed by a period (.), then two digits for the section number, a period (.) and the artifact number. Example: 03.02.01
Artifact name Must be unique within the section

Alternate names (artifact also commonly known as)

This is an alternative name for the artifact.

This column is optional. If it exists, its value can be left empty.

Note! This column is not currently mapped to system functionality. It is not currently possible to change it in maintenance mode.
Definition / Purpose

A free-text description of the artifact

To view the definition in Viedoc TMF: In the left navigation menu, select to expand TMF Admin, and select the TMF Structure page. Navigate to the artifact, and select View.

This column must have values.
Sub-artifacts

A newline-separated list of sub-artifacts

To view the list of sub-artifacts in Viedoc TMF, see above.

Sub-artifacts can be used by TMF users to further classify records.

This column can be left empty.

Core or Recommended for inclusion

ICH Code

These columns are related to GCP.

These columns can be left empty.

Note! This column is not currently mapped to system functionality. It is not currently possible to change it in maintenance mode.
Unique ID Number

An optional unique ID number for the artifact.

This number is validated as follows by Viedoc TMF:

  • If it is available, it must be a valid integer that is unique for the artifact.
  • If it is not available, that is accepted by the TMF system, and represented as 0 in the exported archive.

Sponsor Document

Investigator Document

These columns define what side of the TMF the artifact is: sponsor or investigator (according to GCP).

The values can be X (meaning yes) or NO.

These columns must have values.

From Therese: maybe add info that this refers only to archiving, maybe consider a screenshot? Double check with Cecilia

Process Based Metadata - Number

Process Based Metadata - Name

These columns define trial processes that artifacts can be linked to. This can be useful for trials where records are filed across multiple zones.

Note! These columns are not currently mapped to system functionality. It is not currently possible to change them in maintenance mode.

Trial Level Document

Trial Level MILESTONE/EVENT

Country/ Region Level Document

Country Level MILESTONE/EVENT

Site Level Document

Site Level MILESTONE/EVENT

These columns define the milestones on trial level, country level, and site level.

When a Trial/Country/Site level record in the V 3.2.1 sheet in the template is set to:

  • X, then the corresponding Trial/Country/Site level milestone/event should not be empty. The corresponding milestone/event must include a valid value from the Viedoc Milestones sheet - Name column.
  • Empty, then the corresponding Trial/Country/Site level milestone/event should be empty.
Dating Convention

Defines the dating convention that is used in the metadata of records uploaded to Viedoc TMF

This column can be left empty. If it is empty, the default dating convention will be the version date.

If you select New in the Dating convention field in the Edit artifact window, you can, for example, enter an expiration date as the dating convention.

The Viedoc extensions sheet

This sheet contains Viedoc-specific properties for each artifact.

These are the requirements for the columns:

Artifact # Unique artifact number as defined on the V 3.2.1 sheet.
Sign

This column is not yet used in Viedoc TMF, but it must have values.

The following values are accepted: Required, Optional, or, Not Permitted.
Applicable in Trial

Defines if the artifact is applicable at trial level.

The column must have values.

The following values are accepted: Required, Optional, or, Not Permitted.
Applicable in Country

Defines if the artifact is applicable at country level.

The column must have values.

The following values are accepted: Required, Optional, or, Not Permitted.
Applicable at Site

Defines if the artifact is applicable at site level.

The column must have values.

The following values are accepted: Required, Optional, or, Not Permitted.
Metadata properties

Additional metadata for the artifact.

This column can be left empty.

To view the additional metadata in Viedoc TMF: In the left navigation menu, select to expand TMF Admin, and select the TMF Structure page. Navigate to the artifact, and select View.
File formats

A pipe-separated list of accepted file formats for the artifact. Examples:

  • docx | pdf - only docx and pdf files are accepted
  • * - all file formats are accepted (except for those that are blacklisted for Viedoc)
Accept blinded data

This column is not yet used in Viedoc TMF. It defines if blinded data is accepted for the artifact.

The following values are accepted: YES or NO.
Accept privacy data

This column is not yet used in Viedoc TMF. It defines if privacy data is accepted for the artifact.

The following values are accepted: YES or NO.

The Viedoc milestones sheet

This is an optional sheet. It includes Viedoc-specific properties for each milestone.

If this sheet is not provided, the system will create a list of milestones, under the group Other, based on the following specified milestones in the V 3.2.1 sheet:

  • Trial Level MILESTONE/EVENT
  • Country Level MILESTONE/EVENT
  • Site Level MILESTONE/EVENT

These are the requirements for the columns:

Id Unique milestone Id. This column is mandatory.
Name Unique milestone name. This column is mandatory.
Group One of the four milestone groups defined in DIA Reference Model. This column is mandatory, and the following values are accepted: Start UP, Study Conduct, Close Out, Other
Trial description Description of trial-level records this milestone includes. This column can be left empty.
Country description Description of country-level records this milestone includes. This column can be left empty.
Site description Description of site-level records this milestone includes. This column can be left empty.

Role sheets

The role sheets define the permissions associated with each of the TMF roles.

These are the role sheets:

  • Role SPONSOR-STUDY
  • Role SITESTAFF
  • Role SPONSOR-COUNTRY
  • Role SPONSOR-SITE
  • Role SPONSOR-REVIEW
  • Role SPONSOR-DM
  • Role SPONSOR-UNBLINDED

These are the requirements for the columns:

Artifact # Unique artifact number as defined on the V 3.2.1 sheet.
Study

Defines the permission of the role on study/trial level.

The following values are accepted:

  • NO ACCESS: the role cannot access or see the records in the corresponding artifact on trial level
  • READ: the role can see and download the records in the corresponding artifact on trial level
  • WRITE: the role can see, upload, download, edit, and delete records in the corresponding artifact on trial level. The user needs to be invited on study scope (All production sites) in Viedoc in order to gain WRITE access. Otherwise, the WRITE permission will be translated to READ.
  • REVIEW: the role can see, download, approve, and give comments on the records published in the corresponding artifact on trial level. The user needs to be invited on study scope (All production sites) in Viedoc in order to gain REVIEW access. Otherwise, the REVIEW permission will be translated to READ.

    Note! It is possible for users to be invited to 'All sites' for roles and permissions, but we strongly advise against this.
Country

Defines the permission of the role on country level.

The following values are accepted:

  • NO ACCESS: the role cannot access or see the records in the corresponding artifact on country level
  • READ: the role can see and download the records in the corresponding artifact on country level
  • WRITE: the role can see, upload, download, edit, and delete records in the corresponding artifact on country level. The user needs to be invited on at least country scope in Viedoc in order to gain WRITE access. Otherwise, the WRITE permission will be translated to READ.
  • REVIEW: the role can see, download, approve, and give comments on the records published in the corresponding artifact on country level. The user needs to be invited on at least country scope in Viedoc in order to gain REVIEW access. Otherwise, the REVIEW permission will be translated to READ.
Site

Defines the permission of the role on site level.

The following values are accepted:

  • NO ACCESS: the role cannot access or see the records in the corresponding artifact on site level
  • READ: the role can see and download the records in the corresponding artifact on site level
  • WRITE: the role can see, upload, download, edit, and delete records in the corresponding artifact on site level
  • REVIEW: the role can see, download, approve, and give comments on the records published in the corresponding artifact on site level

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