このレッスンでは、Viedocがサポートしているロールの種類、ユーザーにロールを割り当てる方法、試験にアクセスできるユーザーを確認出来る場所、およびユーザーの詳細について説明します。このレッスンは組織管理者を対象としています。

はじめに

署名に関する重要な情報

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.

Viedocのロールについて

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

試験ユーザーについて

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.

上記の内容は、ユーザーを管理する（組織管理者編）」と「ユーザーを管理する（STM・SIM編）」に共通のものです。

Viedoc Adminでのユーザー設定

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.

上記の内容は、ユーザーを管理する（組織管理者編）」と「ユーザーを管理する（STM・SIM編）」に共通のものです。

ユーザーレポートについて

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. The following more detailed information is contained:

• The Organization name
• The Study name
• Production study GUID
• Demo study GUID
• For PMS studies: Sponsor side Production study GUID
• For PMS studies: Sponsor side Demo study GUID

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.
• Latest system login date/time - information about the latest login of each user.
• 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.
  • If the user has signed the certification associated to their role, the column will display: Certified:Yes.
  • If the user has selected Read & Understood but not signed the associated certification, the column will display: Certified: No.
• User type - indicates the type of user. Possible values are End User or API Client, to indicate if the user is an end user that can log in to the system or a Web API Client that can access the API with a role.
• Latest system login date/time - information about the latest login of each user for end users only, not API client users.

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.

システム施設グループについて

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.

上記の内容は、「ユーザーを管理する（組織管理者編）」と「ユーザーを管理する（STM・SIM編）」に共通のものです。

組織管理者向けのステップ・バイ・ステップガイド

組織管理者を割り当てる

デフォルトでは、各組織に少なくとも1名の組織管理者が存在します。組織管理者をさらに追加する場合、追加操作は組織管理者のみによって実行可能です。

組織管理者を追加するには：

1	Viedoc Adminの組織ウィンドウで、組織管理者フィールドのツールボックスアイコンをクリックします。 組織管理者のポップアップが開きます。
2	管理者を追加のタブで、組織管理者のロールに招待するユーザーのメール電子メールアドレスを入力します。 ヒント！このフィールドに複数の電子メールアドレスを追加することにより、一度に複数のユーザーを招待することができます。電子メールアドレスはセミコロンまたはカンマで区切ります。
3	招待を送信をクリックします。 指定した電子メールアドレスに招待メールが送信されます。

ユーザー画面を使用して、ユーザーを組織のロール（組織管理者、eラーニング管理者、および組織レベルのデザイナー）に割り当てることもできます。

組織レベルのデザイナーには、組織内のすべての試験に対するViedoc Designerへのアクセスとプライベートデザインセクションへのアクセス権が与えられます。以下の画像を参照してください。

eラーニング管理者を割り当てる

ユーザーページからeラーニング管理者を割り当てるには：

eラーニング管理者のロールに割り当てられると、そのユーザーはViedoc eラーニングのプラットフォームにアクセスすることが可能になり、所属している組織を対象にカスタマイズしたユーザードキュメントを作成することができます。eラーニング管理者の権限を持つユーザーの場合、Viedoc Clinicの試験選択画面に以下のアイコンが表示されます。このアイコンからViedoc eラーニングのプラットフォームにアクセスすることができます。

スタディマネージャーを割り当てる

注意！組織管理者のみがスタディマネージャーを追加できます。

スタディマネージャーを追加するには：

組織からユーザーを削除する

Viedocでは、任意のユーザーから組織内のすべての試験における、すべてのロールを一度に削除することが可能です。組織から削除することができるのは、有効になっているロールを持つユーザーのみです。ユーザーに保留中の招待がある場合、そのユーザーを組織から削除することはできません。

組織からユーザーを削除できるのは組織管理者のみです。

注意！この操作を実行しても、ユーザーアカウントは削除されません。削除されるのは、対象ユーザーの組織内のロールと権限のみです。そのユーザーは引き続きログインおよびログアウトすることが可能ですが、その組織の試験を閲覧することはできません。

ユーザーからすべてのロールを一度に削除するには：

1	ユーザー画面でロールを削除するユーザーを見つけ、ユーザーの名前の横にあるツールボックスアイコンをクリックします。 ユーザー設定のポップアップが開きます。
2	組織からユーザーを削除をクリックします。
3	削除をクリックして、ロールの削除を確定します。 対象のユーザーがアクセス出来ていたすべてのロールが削除され、ユーザー画面のユーザーステータスは削除と表示されます。

ユーザーロールレポートのダウンロード

ユーザーロールレポートをダウンロードするには：

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