This lesson describes the types of roles that are supported by Viedoc, how to assign roles to users and where to view the users that have access to a study, and the user details. The instructions are intended for the Organization Administrator (Org Admin).

Introduction

Important information about signatures

This content is shared by the lessons in the following user guides

Admin: "Managing users (for Org Admin)"

Monitors & Project Managers: "Managing users"

Clinic: Signing data

The Study Manager should, in cooperation with the Site Manager(s), ensure that all users of Viedoc are informed, and certify that all electronic signatures created in the system are intended to be the legally binding equivalent of a traditional handwritten signature.

In Viedoc, the purpose/meaning of a signature is always “responsibility” as used in Sec. 11.50 of Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) part 11. The signer is thereby acknowledging his/her responsibility for the entered data. Viedoc keeps account of what was signed, who signed it, and when the signature was performed.

About roles in Viedoc

This content is shared by the lessons in the following user guides

Admin: "Managing users (for Org Admin)"

Monitors & Project Managers: "Managing users"

Two types of roles

Viedoc supports two different types of roles.

1. System roles are roles that are predefined in the system and give access to Viedoc Admin or Viedoc Designer, see System roles.
2. Clinic roles are roles that are study-specific and give access to Viedoc Clinic, see Clinic roles.

The Organization Administrator invites the Study Manager. The Study Manager can assign users to system roles and clinic roles. The Study Manager can also delegate the management of clinic roles to the Site Manager.

System roles

The system roles are predefined in Viedoc, they cannot be adjusted for your study. The system roles give access to various features in Viedoc Admin or Viedoc Designer.

The following system roles are available.

One organization can have more than one Organization Administrator. One study can have more than one Study Manager, Designer, Unblinded Statistician, Dictionary Manager, Reference Data Source Manager and API Manager. One site can have more than one Site Manager.

Clinic roles

The clinic roles, and the rights that belong to these roles, can be set up in the study design in Viedoc Designer. They are study-specific and give access to Viedoc Clinic. Clinic roles are assigned to site users by the Study Manager or the Site Manager. Each study can have an unlimited number of clinic roles.

Examples of clinic roles are:

• Investigator
• Study Nurse
• Study Coordinator
• Data Manager
• Medical Coder

About the study users

Overview of users in the organization/study/site

A list of users can be viewed at the following three places:

1. On the Users page. This page displays a list of users assigned to any role in any study within the organization.
2. In the Study crew window. This window displays a list of all users assigned to a system role in the study.
3. On the Site users tab of the site settings window. This tab displays a list of all users assigned to a clinic role within that specific site.

Note! All three user lists only display the users and roles you have permission to manage (invite or remove). If you are a Study Manager, you can also see the Organization Administrator. If you are a Site Manager, you can also see the Study Manager. However, in both cases you cannot invite users to these roles or remove these roles from users.

Users

The Users page lists all users within the organization, and displays the following information:

• Name of the user
• User ID (in parentheses behind the user's name)
• E-mail address
• Study/studies and site(s) the user has access to
• Role(s) assigned to the user
• Viedoc skill level of the user (see Viedoc skill level)
• Status of the user (see User status)

If a user has no approved roles, because the invitation is still pending or rejected, or because the roles have been removed, only the user's e-mail address is displayed and all the other fields remain empty.

On this page, you can (see image):

1. Search for a specific user among all users within the organization by entering the user’s name or e-mail address in the search field

2. Sort the list of users by name, status or date of creation

3. Group the list of users by study by selecting Studies in the Group by field

4. Invite organization users (only available for the Organization Administrator)

Study crew

The Study crew window lists all users in the study that are assigned to a system role, and displays the following information:

• Name of the user
• User ID (in parentheses behind the user's name)
• E-mail address
• Role(s) assigned to the user
• Date and time the user has been invited to that role (if the invitation is still pending) or has access to that role (if the invitation has been accepted)*
• Viedoc skill level of the user (see Viedoc skill level)
• Status of the user (see User status)

*If the user has multiple roles, the date and time of invitation or acceptance of the first role that gives access to that site is displayed.

You can sort the users by name, role, date of (accepted) invitation and status. To sort the users, click on the column headers, or click on the arrows to the right of the column header. You can sort the users in ascending and descending order.

Site users

The Site users tab in the Site settings window lists all users with clinic roles that have access to that site, and displays the following information:

• Name of the user
• User ID (in parentheses behind the user's name)
• E-mail address
• Role(s) assigned to the user
• Date and time the user has been invited to that role (if the invitation is still pending) or has access to that role (if the invitation has been accepted)*
• Viedoc skill level of the user (see Viedoc skill level)
• Status of the user (see User status)

*If the user has multiple roles, the date and time of invitation or acceptance of the first role that gives access to that site is displayed.

You can sort the users by name, role, date of (accepted) invitation and status. To sort the users, click on the column headers, or click on the arrows to the right of the column header. You can sort the users in ascending and descending order.

Viedoc skill level

The Viedoc skill level gives an indication of how experienced the user is in using Viedoc. It is based on the number of logins by that user.

Skill level	Icon	Description
Rookie		≤ 20 logins
Semi-pro		21-100 logins
Pro		101-1000 logins
Legend		> 1000 logins

User status

The status of the users is displayed in the status column:

Status	Icon	Description
Online		The user is currently logged in to Viedoc, and has no pending invitations.
Offline		The user is currently not logged in to Viedoc, and had no pending invitations.
Pending		The user has at least one pending invitation to a role. The question mark is displayed even if the user has accepted invitations to other roles.
Pending certification		The user has mandatory documentation assigned that was not confirmed as read & understood.
Rejected		The user has rejected all invitations to roles. The user has never had access to the study.
Locked out		The user is locked out from Viedoc (the user has entered the wrong password three times in a row).
Removed		The user has had roles in the study before, but has currently no roles left.

For the Users page (see Users), the following applies:
If the users are not grouped by study, the user's status symbol will reflect the overall status in all studies you have access to. That means, if the user has one pending invitation in one of the studies, the status will be pending and a red question mark will appear. If the users are grouped by study, the status symbol will reflect the status per study. That means that a user's status can be pending in one study, and logged in in another study.

The content is shared by the lessons 'Managing Users (OA)" and "Managing Users (STM and SIM)"

User settings in Viedoc Admin

To view the details of a specific user, click the toolbox icon behind the name of that user in any of the previously described user lists. The User Settings window opens:

The User Settings window displays the name and email address of the user, the user ID (in parentheses), the status and the skill level. You can perform the following actions:

1. On the Details tab, you can view the user's name and contact details.

2. On the Studies and Roles tab, you can view a list of all roles and sites the user has access to, including the date and time of invitation/acceptance of that role. The roles are grouped per study. You can delete roles by clicking the trash can icon next to the role.

3. On the Authentication log tab, you can view a list of logins by the user, including date and time, the IP address, and the browser that was used. The number of displayed entries is limited to the latest 100 logins.

4. On the Reset Password tab, you can reset the password for that user, if the user has forgotten their password and does not have the phone number that can receive a text message or a secondary email address. Viedoc will send a notification to the user with a link to create a new password.

Note! The authentication code will be required if the user wants to reset their password using the Forgot your password? link on the login page. The authentication code is sent to the phone number the user set to receive text messages or to the user's secondary email address. If neither of these options are selected, the user needs to contact their Study Manager to receive a link to reset their password.

5. On the Communication Log tab, you can view the latest 20 communication logs for a user and download an Excel file with the complete user-specific Communication Log containing information about email and SMS communication to study users. All users with access permissions (Study/Site Managers) to the User settings in Viedoc Admin can access the Communication Log.

Note! Email and SMS communication logs before the Viedoc 4.70 release are available, however these do not have the same level of detail.

The content is shared by the lessons 'Managing Users (OA)" and "Managing Users (STM and SIM)"

About the user report

For each study, you can download user logs in PDF and Excel format with information about all users and roles for the sites you have access to. See Downloading the user logs for instructions.

Note! Only production sites and roles/users for production sites are included in the logs.

The content of the logs depends on the system role that you have, as follows:

Log of users and roles in PDF

The Log of users and roles PDF contains information about all users and roles for the sites you have access to, grouped in the following chapters:

1. Summary - the summary of active/inactive roles, active/inactive users as well as data contributors, grouped in one section per site.
   • An Active role is the current distinct role all active users have for a site.
   • An Inactive role is a role that was previously assigned but currently lacks any active user.
   • An Active user is a user with at least one active role.
   • An Inactive user is a user who had at least one role at a site, but all roles for the site have been revoked.
2. Roles - a list of the permissions associated with each role and corresponding history, grouped in one section per site.
3. User log per site - a list of all users who ever had access to data, including user activity, grouped in one section per site.
4. User account logs - a list of the change history of all user accounts for the users listed in the above sections of the log, grouped per user (identified by the User ID).

User administration log in Excel

The User administration log contains information about all users and roles for the sites you have access to, with the following sheets:

1. Report Info - general information about when and by whom the log was generated, and some information about the study status.
2. User Access Log - a list with detailed information about user access, showing one row per site and role, including clinic roles and system roles. Some columns in this sheet are further explained here:
   • Site Group - indicates when a user is granted access to the site through a site group invitation. Possible values are Training sites, Countries, and All sites.
   • 2FA - indicates what level of two-factor authentication the user has. Possible values are Study level, Account level, or No two-factor authentication enabled.
   • Certified - indicates if the user is certified for the role. Possible values are Yes, No, or an empty cell for roles that don't have mandatory training sections to read.
3. Certification Log - a list of certifications per user. Certifications performed before the release of 4.65 lack information about what roles the certification applies to. That is, the cells in column Certified With Roles are empty.
4. Summary - a summary of users per site with information about country, side code, site name, number of active/inactive users, and date/time of last access change.
5. Account Settings Log - a list with all user accounts setting changes with user ID, change log, user name, and date/time.

Communication log in Excel

There are two different Communication logs. One contains user-specific and one contains study-specific communication information.

Note!

• This Communication log does not include any subject-related communication (Viedoc Me).
• Email and SMS communication logs before the Viedoc 4.70 release are available, however these do not have the same level of detail.

User-specific information

The user-specific Communication log contains information about email and SMS communication to the study users.

All users with access permissions (study/site managers) for the User Settings in Viedoc Admin can view the Communication Log for a specific user. The Communication Log tab has the following columns:

• Date & Time
• Message type
• Status - Note! The status labels are Success or Failed, where Success means that the message was successfully sent from Viedoc, and Failed means that the message failed to send from Viedoc. Further, if the status was Success but the recipient did not receive a message, then the problem lies outside of Viedoc. Please contact your PS representative if this should occur, or if your status returns Failed.

The Excel file contains a sheet named User Communication Logs and includes all email and text message (SMS) communications to the study user on the same Excel sheet.

Note! Users must have activated the Viedoc account and accepted at least one invitation in order to have their communication included in the Communication Log tab in the User Settings window.

The User Communication Logs sheet in the Excel file contains information about user-specific communication – this is the user activity in Viedoc that is unrelated to a specific study:

• Reset password
• Verification & notifications (changing telephone number/email address)
• 2FA (email/SMS)

The file name format is: UserCommunicationLog-UserID-YYYYMMDDhhmmss. (Using UTC)

All the logs are included in the same Excel sheet. The excel sheet has the following columns:

Study-specific information

In Admin, under Users - Group by Studies, in the User Logs dropdown list, a separate file called User communication log is available containing the information listed below.

This log contains information about study-specific communication and emails only, related to:

• Alerts
• Invitations to a specific role within a study
• Notifications (study access deletion, etc.)

The Excel file contains a sheet named Study Communication Logs.

The file name format is: UserCommunicationLog-YYYYMMDDhhmmss. (Using UTC)

The Excel sheet has the following columns:

Note!

• This log does not include user-specific information related to Reset Password, 2FA, etc.
• This log file is available in Viedoc Admin only.

The content is shared by the lessons 'Managing Users for Org Admin" and "Managing Users and is called User logs in the single source file"

About system site groups

The Study Manager can give users access to individual sites, or to a groups of sites at once. These groups of sites are called system site groups and are automatically created by the system when sites are added to the study. The following systems site groups are created by the system:

• All sites, containing all sites in the study.
• All production sites, containing all production sites in the study, including the sites that are in both production and training mode.
• Country-specific, for example ‘Sweden’, containing all production sites (including the sites that are in both production and training mode) in that specific country in the study.

When you invite users to a system site group, the users will automatically receive instant access to all sites in that group, including all future sites that will be added to that group at a later time. For example, if you invite a user to the country 'Hungary', that user will receive access to all sites in Hungary. Similarly, users that were invited to a system site group will automatically lose access to a site if that site is removed from the group. For more information about system site groups, see Managing study sites.

The content is shared by the lessons 'Managing Users (Org Admin)" and "Managing Users (STM and SIM)"

Step-by-step guides for the Org Admin

Assigning an Organization Administrator

By default, every organization has at least one Organization Administrator, added by the system administrator at Viedoc Technologies. Additional Organization Administrators can only be added by the Organization Administrator.

To add an Organization Administrator:

1	In the Organizations window in Viedoc Admin, click the toolbox icon in the Organization Administrators field. The Organization Admins pop-up opens.
2	On the Add administrators tab, enter the e-mail address of the user you would like to invite to the role Organization Administrator. Tip! You can invite multiple users at once by adding multiple e-mail addresses in the field. Separate the e-mail addresses with a semi-colon or comma.
3	Click Send invite. An invitation e-mail is sent to the e-mail address you specified.

You can also assign users to organization roles (Organization Administrator, eLearning Administrator, and Designer at organization level) via the Users page:

A Designer at organization level receives access to Viedoc Designer for all studies within the organization, and receives access to the Private Designs section, see image below.

Assigning an eLearning Administrator

To assign an eLearning Administrator via the Users page:

1	On the Users page, click Invite Organization users. The Organization team pop-up opens.
2	Enter the e-mail address of the user you would like to invite, and select the role to which you would like to invite the user. You can add multiple roles by clicking in the Select roles to assign field. Tip! You can invite multiple users at once by adding multiple e-mail addresses in the field. Separate the e-mail addresses with a semi-colon or comma. All entered users will be assigned to all selected roles.
3	Click Save changes. An invitation e-mail is sent to the e-mail address(es) you specified.

Once a user has been assigned to the role eLearning Administrator, the user can access the Viedoc eLearning platform and create customized user documentation for your organization. For users with eLearning Administrator permissions, the following icon appears on the landing page in Viedoc Clinic, which gives access to the Viedoc eLearning platform.

Assigning a Study Manager

Note! Study Managers can only be added by the Organization Administrator.

To add a Study Manager:

Removing a user from the organization

Viedoc offers the possibility to remove all roles from a user in all studies within the organization at once. Only users that have active roles can be removed from the organization, if the user has any pending invitations, it is not possible to remove the user from the organization.

Only the Organization Administrator can remove a user from the organization.

Note! This feature does not remove the user account, it only removes all roles and permissions within the organization. The user can still log in and log out, but not view any studies within that organization.

To remove all roles from a user at once:

1	On the Users page, scroll to the user whose roles you would like to remove. Click the toolbox icon behind the name of the user. The User Settings pop-up opens.
2	Click Delete user from this organization.
3	Click Delete to confirm that the roles should be removed. All roles to which the user had access will be removed and the user's status will appear as Removed on the Users page.

Downloading the user roles report

To download the user roles report:

1

On the Users page, select to group the users by Studies.

2

Scroll to the study from which you would like to download the user report, and, if the Log of users and roles PDF has not been previously generated for the study, you can generate it by clicking the Generate a PDF file 'Log of users and roles' link: As a result, the PDF file that contains a full history of all roles and users, permissions, user logs sorted per site, and all user account logs sorted per user is generated and available for download: After the PDF file was generated for the study, you can choose to: Download the latest generated PDF for the country/site selection - the most recent version generated has a date and time stamp and is stored on the server, making it possible to directly download the file instead of generating a new one, which would be more time consuming, or Generate a new PDF file - if you need a more recent version than the one available for download.

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