Introduction

If the Enable documentation and training option is checked under Study Settings (see General study settings), a separate Documentation section is available in Viedoc Admin under Study Settings, that allows to:

• Make the Viedoc eLearning curriculums available for clinic users.
• Enable site user certification, by setting up mandatory documentation to be read and signed by the users.
• Add new URL(s) or upload file(s) and make them available to clinic users.

For ongoing studies started before Viedoc release 4.51

If the Enable documentation and training option is checked under Study Settings in Viedoc Admin for ongoing studies (started before Viedoc release 4.51), any already configured eLearning sections in Viedoc Designer will not be available anymore. Instead, these can be copied and transferred from Viedoc Designer to Viedoc Admin, by clicking the link that is available when accessing the Documentation page, as illustrated below:

Note! This operation can be performed only:

• if there were existing eLearning sections defined in Viedoc Designer before selecting the Enable documentation and training option under Study Settings in Viedoc Admin, and
• before any new sections are added in Viedoc Admin under Documentation.

As a result, the existing eLearning sections from Viedoc Designer are copied and listed under the Documentation tab and can be further configured (that is, assigned to specific roles/sites), as described later in this lesson.

For new studies starting after Viedoc release 4.51

For new studies, starting after Viedoc release 4.51 in May 2019, the following 5 role-based Viedoc eLearning curriculums for site staff are provided by default as training sections:

In order to make these curriculums available for the different clinic roles, you need to edit each of the training sections, as described in section Editing a training section below.

Overview of Documentation page

The Documentation tab under Study Settings provides a list of all the existing sections, as illustrated in the following image.

A training section is a piece of documentation (either a file or an URL) that can be made available (as optional or mandatory) for specific user roles within specific sites, as instructed in Managing training sections below.

On the top bar you can see:

• to the left - a summary of the total number of sections as well the number of archived sections.
• to the right - the plus-icon for adding a new section. See Adding a new section below.

For each section in the list the following information is provided:

• Section - the icon illustrating the section type, as listed in the table below, followed by the section name as set when adding or editing the section (see Editing a section below). By clicking the section name link you can open the respective file/URL.
• Target sites - the site(s) the section is set for.
• Mandatory for - the roles for which the section is set as mandatory.
• Optional for - the roles for which the section is set as optional.
• Edit section - the tools icon link that allows you to open the section page where you can edit/archive/delete the section. See Editing a section below.

The section icons for various types of files/URLs used are listed in the table below:

Icon	Description
	URL to Viedoc eLearning system
	URL (other than Viedoc eLearning, mentioned above)
	PDF file
	Word document
	Excel file
	Power Point file
	Other file type than the ones mentioned above

Managing training sections

Adding a new section

To add a new section, follow the steps below.

1

Click Add a new section link on the top right of the Documentation page. The Add a new training section page is displayed. Here you can set the following: Section URL or file - mandatory - if you want to add a link, just type in the URL - if you want to add a file, click Upload a file to the right, browse for the file and add it. Notes! The restricted file formats are listed in Blacklisted file formats chapter in this lesson. The maximum file size is 100MB. The size of the uploaded files is counted in the total amount of data used by a study, that can be monitored in Viedoc Admin on the Studies overview page and on the Study page - Used data storage. Section title - type in the section title that will be displayed both in the Documentation page in Viedoc Admin under Study Settings, as well as in Viedoc Clinic. This field is mandatory. Priority - the number that defines the position of the section in the list displayed under the Documentation page, from 1 (first position in the list) to n (last position in the list), where n is the total number of sections. By default, this is set to the last position (n). This field is mandatory. Description - additional descriptive text for the section, that will be displayed in Viedoc Clinic under Documentation & training, as illustrated in section How it looks in Viedoc Clinic. This field is optional. Target sites - click and select the site(s) or site group(s) that the clinic user shall have access to in order to see the section in Viedoc Clinic. If a site group is selected (including All sites), the site(s) added to the group in the future will also get access. If empty, the section will not be displayed in Viedoc Clinic under Documentation & training, as illustrated in section How it looks in Viedoc Clinic. This field is optional. Require signing for following roles - click and select the clinic roles that will have the section as mandatory reading in Viedoc Clinic. If you select All roles, the clinic roles added in the future will also get the section as mandatory reading. If empty, the section will not be displayed in Viedoc Clinic under Documentation & training > Mandatory section. This field is optional. Important! Users to whom mandatory documentation is assigned will not be able to launch the study (except for demo mode, depending on the study settings, see General study settings) until the user has read and signed all the mandatory documentation. Require re-signing after # of days - if checked, a new signature is required in Viedoc Clinic after the specified number of days (default is 365) from the previous signing date. If the checkbox is selected, the number of days is mandatory. This field is optional and unchecked by default. Optional for following roles - here you can add reference documentation for your study that will be available for clinic users. Click and select the clinic roles that will have the section as optional reading in Viedoc Clinic. If you select All roles, the clinic roles added in the future will also get the section as optional reading. If empty, the section will not be displayed in Viedoc Clinic under Documentation and training > Optional sections. This field is optional.

2

Click Add section on the top right of the page. The section will be added to the list under the Documentation page.

Editing an existing section

To edit an existing section, follow the steps below.

1	Click the toolbox icon to the right of the section in the list: The edit section page opens.
2	Perform the changes you need and click Save changes in the the top right of the page. You can edit all the fields, except for the Section URL/file. For a detailed description of the fields, see Adding a new section.

Archiving/Restoring a section

It is possible to archive an existing section, for versioning purposes. For example, if we have an existing section with the study protocol file (version 1), and, at some point, we get an updated version of the file (version 2) that we want to make accessible for clinic users. In this case, we would archive the section that contains the version 1 of the file and would add a new section where we upload the version 2 of the study protocol.

An archived section will no longer be accessible in Viedoc Clinic under Documentation & training (as illustrated in section How it looks in Viedoc Clinic). An archived section can be restored at any time, becoming accessible again in Viedoc Clinic, according to the settings made for the section.

To archive an existing section, follow the steps below.

1	Click the toolbox icon to the right of the section in the list: The edit section page opens.
2	Click Archive: The edit section page closes and the section is displayed as Archived in the list under the Documentation tab: An archived section will no longer be accessible in Viedoc Clinic. An archived section can be restored at any time, becoming accessible again in Viedoc Clinic, according to the settings made for the section.

To restore an archived section, follow the steps below:

1	Click the toolbox icon to the right of the archived section in the list: The edit section page opens.
2	Click Restore: The section will be restored and become accessible again in Viedoc Clinic, according to the section settings.

Deleting a section

It is possible to delete an existing section. Deleting a section cannot be undone, so if you need to re-use the section, you might want to archive it instead (see Archiving/Restoring a section above). An archived section can be restored afterwards, while a deleted section will be completely removed. Therefore, if you like to keep a history over the documentation versions that have been available for reading throughout the study it is recommended to archive instead of deleting.

A deleted section will no longer be visible in Viedoc Clinic.

To delete an existing section follow the steps below:

1	Click toolbox icon to the right of the section in the list: The edit section page opens.
2	Click Delete this section in the bottom of the page: A confirmation pop-up is displayed.
3	Click Confirm to delete the section, or Cancel to return to the edit section page without deleting.

How it looks in Viedoc Clinic

For example, if we have the following sections defined in Viedoc Admin under Study Settings > Documentation:

The user having the Monitor role for the Demo Site, will see in Viedoc Clinic, on the Study Start page, under Documentation and training, the following:

For more details about the Documentation and training section in Viedoc Clinic, see Documentation and Training.

Users not certified

The clinic users having mandatory documentation assigned who have not read and signed all the mandatory documentation yet, are displayed in the user listings in Viedoc Admin with the status Not certified. For details about user status see Managing users.

Information on which users have been certified, for which roles and which sections, is also included in the 'Log of users and roles' PDF report that can be downloaded from Viedoc Admin, as described in Managing users.

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