Customizing a template

Introduction

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

The eTMF template is implemented in an Excel file.

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

With your Viedoc eTMF 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 eTMF, click the Templates tab at the top of the page:

In Viedoc eTMF, 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 eTMF 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 eTMF 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 DIA 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 eTMF, go to the TMF structure tab, 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 eTMF, see above. Sub-artifacts can be used by eTMF users to further classify documents. 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 eTMF: 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 eTMF 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.
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 document 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 documents uploaded to Viedoc eTMF 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 eTMF, 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 eTMF, go to the TMF structure tab, navigate to the artifact, and click 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 eTMF. 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 eTMF. 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 documents this milestone includes. This column can be left empty.
Country description	Description of country-level documents this milestone includes. This column can be left empty.
Site description	Description of site-level documents this milestone includes. This column can be left empty.

Role sheets

The role sheets define the permissions associated with each of the eTMF 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 documents in the corresponding artifact on trial level `READ`: the role can see and download the documents in the corresponding artifact on trial level `WRITE`: the role can see, upload, download, edit, and delete documents 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 documents 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 documents in the corresponding artifact on country level `READ`: the role can see and download the documents in the corresponding artifact on country level `WRITE`: the role can see, upload, download, edit, and delete documents 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 documents 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 documents in the corresponding artifact on site level `READ`: the role can see and download the documents in the corresponding artifact on site level `WRITE`: the role can see, upload, download, edit, and delete documents in the corresponding artifact on site level `REVIEW`: the role can see, download, approve, and give comments on the documents published in the corresponding artifact on site level