Managing Study User Access in EDC Tools


This article describes how to manage a Vault CDMS user’s access to Studies and study-related data.

Accessing EDC Tools

To access the EDC Tools administration area, click the Tools tab in the primary navigation bar, and then click EDC Tools.

Access EDC Tools from the Tools Tab

By default, once you open EDC Tools, Vault displays a list of automated deployment Studies. You can use the Automatic and Manual radio buttons to switch between these listings. Select Manual to access your manual deployment Studies.

Select Automatic or Manual

For manual deployment Studies, click on the Study to open EDC Tools for that Study. For automatic deployment Studies, click on the Study to open the Deployments page. From here, you can click on an Environment to open EDC Tools for that study environment.

Once you’ve entered the EDC Tools area, select your Study if you have access to more than one Study. To return to the study list, click Back to Study Listing.

Viewing Users

When you add a user to a Study from EDC Tools > Users, Vault automatically creates EDC Execution User Role object records for each user added, and additional records for each role assignment for that user.

You can view a list of Users in your Study and add new Users from EDC Tools > Users.

Users in EDC Tools

Automated Deployment Studies

For automated deployment Studies, you can access EDC Tools > Users from the Deployments page by clicking the Users tab. You will manage users across all study instances (environments) from this location.

Users tab

Manual Deployment Studies

For manual deployment Studies, you can access EDC Tools > Users from the Users tab within your Study.

Adding Users to an Automated Deployment Study

You can give a user access to your study in one or more environments from EDC Tools > Users.

  1. Navigate to your Study Tools > EDC Tools.
  2. Click your Study to open the Deployments page.
  3. Click Users. Users in EDC Tools

  4. Click New User. Vault opens the New User dialog. New User button

  5. Select one of the following:
    • Add a new or existing User in the current vault: When you select this option, you create a new User or add an existing User to your Study.
    • Add an existing User from another vault: When you select this option, you add an existing User in another vault (either on your own domain or another domain) to the current vault and to your Study. Note that these options only display for users with permission to add cross-domain Users. If you don’t have the Add Cross-Domain Users permission, you can only create or add existing Users in your current vault. Select an origin for the new user
  6. Fill the required fields. As you enter information, Vault attempts to find an existing user that matches that information. If there is an existing user, you can click their User Name in the results column to add them to the study.
  7. Optional: When creating new Principal Investigator users, you can select the Add as Principal Investigator checkbox to add them to your Study’s list of Principal Investigators. This user will then be available in the Principal Investigator field during Study Site creation. Add as Principal Investigator checkbox

  8. Click Set Study Access.
  9. If you would like to grant this user access with the same Study Role to all environments automatically, choose Yes for Grant access to all Environments in the current vault. Otherwise, leave this as No.
  10. Select an Environment.
  11. Select a Study Role to assign to this user.
  12. Set Study Access to Enabled to allow the user to access study-related records. Select Disabled to prevent the user from accessing study-related records.
  13. To grant the user access to all Sites in your Study, select Yes for Grant Access to All Sites. To set access by country or by site, select No.
  14. If you selected No for Grant Access to All Sites, select Countries and Sites to grant access to.
  15. Optional: Repeat steps 10 through 14 to grant access in other environments. Set Study Access for all environments

  16. Click Add User, or click Add and New to add this user and immediately begin creating another User. Add User button

At any time during user creation, you can click Back to return to the previous step.

Adding Users to a Manual Deployment Study

To add a user to a Study from EDC Tools > Users:

  1. Navigate to the Users tab in the EDC Tools area.
  2. Click New User. New User button

  3. Select one of the following:
    • Add a new or existing User in the current vault: When you select this option, you create a new User or add an existing User to your Study.
    • Add an existing User from another vault: When you select this option, you add an existing User in another vault (either on your own domain or another domain) to the current vault and to your Study. Note that these options only display for users with permission to add cross-domain Users. If you don’t have the Add Cross-Domain Users permission, you can only create or add existing Users in your current vault. Select an origin for the new user
  4. Fill the required fields. As you enter information, Vault attempts to find an existing user that matches that information. If there is an existing user, you can click their User Name in the results column to add them to the study.
  5. Optional: When creating new Principal Investigator users, you can select the Add as Principal Investigator checkbox to add them to your Study’s list of Principal Investigators. This user will then be available in the Principal Investigator field during Study Site creation. Add as Principal Investigator checkbox

  6. Click Set Study Access.
  7. Select a Study Role to assign to this user. The Study Role determines which areas of the application this user can access and what tasks they can perform there. See details about study roles here. Set Study Access for the new user

  8. Choose Enabled to prove this user with Study AccessStudy Access allows the user to access assigned sites in the study. You can choose Disabled to disallow Study Access for this user.
  9. To provide a user access to all sites in your study, select Yes for Grant access to all sites. For users who will have a different role for different sites, select No.
  10. If you did not grant access to all sites, select a Country or Site to give the user access to.
  11. Click Add User, or click Add and New to add this user and immediately begin creating another User. Add User button

At any time during user creation, you can click Back to return to the previous step.

Editing Existing Users

You can edit existing study users from EDC Tools > Users.

To edit a User:

  1. From EDC Tools > Users, click into a User.
  2. Make any changes.
  3. Click Save.

Any changes to user access are effective immediately.

For cross-domain users, you can only edit their Security Profile and Application Role in your current vault. Any other changes must be made on that user’s home domain.

Cross-Vault & Cross-Domain Users

In Vault, user accounts exist within a single domain. One user may not have access to every vault on a domain. Cross-vault users have access to multiple vaults on a single domain. Cross-domain users have access to multiple vaults on different domains. You can add users from other vaults on your domain, or users from other domains, to your Study from EDC Tools > Users.

These users can use a single set of login credentials to log in to any vault they have access to, regardless of domain. Cross-domain users log into their home domain, but the session is Vault specific. The My Vaults page, if enabled, is served from the cross-domain user’s Vault on their home domain.

See Cross Domain Users & Authentication for additional details about how cross-domain user accounts work in Vault.

Importing Study Users

You can also create users in your Study in bulk by importing them as User records from a CSV (.csv) or Excel ™ (.xlxs) file.

Creating the Import File

You can create an import CSV file using this template:

Note that your import CSV must be smaller than 100mb. We also recommend that you not import more than 1000 users at once.

  1. Download the template and open it in your preferred editor.
  2. Add a row for each User you want to add to your Study.
  3. Save your file.

Required Columns

The following columns are required in your import file:

Column Details
Study Environment (This column is only required for automated deployment studies. If your study uses manual deployment, do not include this column in your import file.) Enter the Study Environment (Study Instance) that you want to add this user. You can see a list of Study Environments for your Study on the Deployments page. To give the user access to all Study Environments for a Study, enter “all environments” in this column.
Last Name Enter the user’s last name.
First Name Enter the user’s first name.
User Name Enter the user’s User Name.
Study Status Enter Enabled to provide the user with access to the Study or Disabled to disallow the user from accessing the Study.
Security Profile Enter the user’s security profile. You can view a list of Security Profiles in your vault from the Add User dialog in EDC Tools > Users or from Admin > Users & Groups. If your vault has the Role by Study feature enabled, don’t include this column. If you include this column, Vault ignores the values in your CSV at import and instead assigns the Security Profile tied to the Study Role.
Study Role Enter an Application Role to assign the user. You can view a list of Application Roles from the Add User dialog in EDC Tools > Users or from Admin > Users & Groups > Application Roles. You can also view a list from Tools > Role Management if that feature is enabled in your vault. The Application Role is labeled as Study Role if your vault has the Role by Study feature enabled.
Company* Enter the user’s Company.
Email Enter the email address to associate with the user’s account.
Timezone Enter the user’s timezone. This column requires a special format. See a list of timezones and their appropriate entry format here.
Site Access Enter a Site or list of Sites (comma separated) to allow the User to access. You can view a list of Sites from EDC Tools > Sites. You cannot list all Sites. Provide the User with Study Access to give all-site access.
Country Access Enter a Study Country or list of Study Countries (comma separated) to allow the User to access. You can view a list of Countries from EDC Tools > Study Countries.
Title* Enter the user’s Title.
Language Enter the user’s language, using the language tag. See a list of languages and their appropriate entry formats here.
Locale Enter the user’s locale, using the locale tag. Available Locales are limited by the selected Language. See a list of locales by language and their appropriate entry format here.
Security Policy Enter Basic for the user’s security policy.

* Values for Company and Title are optional. You must include these columns in your import file, but you can choose to leave them blank.

Vault automatically populates the License Type (Full User) and the Generate temporary password and notify user (selected) fields for each new User upon successful import.

For cross-domain and cross-vault users, you only need to populate the following columns:

  • User name
  • Security Profile
  • Application Role
  • Site Access
  • Country Access

Vault ignores any other user details, because changes outside of these columns must be made in the user’s home vault or domain.

Importing the File

To import the file:

  1. Navigate to EDC Tools > Users.
  2. Click Import From File. Import From File button

  3. Click Select a file.
  4. Browse to and select your import file.
  5. Vault uploads the file and validates your new User records. Validation results display in the Preview area. (See possible validation errors below.)
  6. Optional: If your import file contains any validation errors, edit the file to resolve them. Then click Change File to re-upload.
  7. Once all of your new User records are ready for import, click Import. Vault begins a job to import and create all of your new User records. Vault sends you an email notification when the job is complete.
  8. Click Job History or Back to Study.

Import Statuses

There are three possible statuses for a new User record as you prepare it for import:

Status Explanation
Error There is at least one error on this row. Errors indicate missing or invalid values.
Warning There is at least one warning on this row. Warnings indicate conflicts with existing User records.
Ready for Import This User record is complete and can be successfully imported into the vault.

Validation Errors

Error Field Explanation Steps to Resolve
{Field} is required All This field is required. Provide a value for this field and re-upload your import file.
Environment does not exist Study Environment The Study Environment provided does not exist. Verify that you entered the Study Environment correctly, correct any errors, and re-upload your import file.
Invalid Email Format Email The email provided is in an invalid format. Verify that the email address is correct, and is in the someone@example.com format and remove any special characters. re-upload your import file.
Invalid User Name User Name The user name provided is in an invalid format, or Vault could not locate a cross-domain user with the user name included in your import file. Remove any special characters (@ ( ) [ ] \ . : ; < >), correct the cross-domain user’s user name, and re-upload your import file.
Invalid Timezone Timezone The timezone provided is in an invalid format. Enter a supported Time Zone and re-upload your import file. See a list of timezones and their appropriate entry format here.
Invalid Locale Locale The Locale provided does not exist in this vault, or it is not valid for the selected language. Enter a supported Locale and re-upload your import file. See a list of locales and their appropriate entry format here.
Invalid Language Language The language provided is not supported. Enter a supported Language and re-upload your import file. See a list of languages and their appropriate entry format here.
Invalid Status Study Status The Study Status provided is not an option for this field. Enter Enabled or Disabled and re-upload your import file.
Invalid Security Profile Security Profile The Security Profile provided does not exist in this vault. Enter a Security Profile that exists in the vault and re-upload your import file. You can view a list of Security Profiles in your vault from the Add User dialog in EDC Tools > Users or from Admin > Users & Groups.
Invalid Security Policy Security Policy The Security Policy provided is not an option for this field. Enter Basic and re-upload your import file.
Invalid Application Role Application Role The Application Role provided does not exist in this vault or is spelled incorrectly. Enter a valid Application Role and re-upload your import file. You can view a list of Application Roles from the Add User dialog in EDC Tools > Users or from Admin > Users & Groups > Application Roles.
Site Access Invalid Site The Site provided does not exist in the Study or is spelled incorrectly. You also cannot list all Sites. Provide the User with Study Access to give all-site access. Enter a valid Site for your Study and re-upload your import file. You can view a list of Sites from EDC Tools > Sites.
Country Access Invalid Country The Country provided does not exist in the Study or is spelled incorrectly. Enter a valid Study Country for your Study and re-upload your import file. You can view a list of Study Countries from EDC Tools > Study Countries.
Inactive User All The cross-domain user is marked Inactive in their home domain. Remove the inactive cross-domain user’s row from your CSV and re-import.
Insufficient access to create Cross Domain User All You do not have the Admin: Security: Users: Add Cross-Domain Users permission, which is required to create cross-domain users. Remove the cross-domain user’s row from your CSV and re-upload.}

Validation Warnings

Warning Explanation Steps to Resolve
Duplicate user record The import file contains two (or more) duplicate rows for a single User record. Remove the duplicate rows from your import file. For automated deployment Studies, the import file contains two (or more) duplicate rows for a single combination of User and Study Environment.
User exists. Applying Study access. This User already exists in the vault or Study Environment. Upon import, Vault does not create a new User record, and instead only adds this User to the Study. Remove this User row from your import file. You can add this User to your Study

Exporting Study Users

You can export user information in your Study into a CSV file. This can be useful for record keeping and user inventory. Note that any filters you apply to the listing of Users will also apply to your export. You can also export a list of study users to import into another study, copying all Study user access settings into that Study.

To export study users:

  1. Navigate to EDC Tools > Users.
  2. From the Actions menu, choose CSV. CSV in the Actions menu under Export

  3. Vault begins a job to create a CSV of your Users. When finished, Vault will send you an email notification with a link to download the output file.

The study user export includes all columns listed above, as well as a Last Login column (the date and time that the User last logged into Vault). To import your users into another Study, update the Site Access and Country Access columns with values from the target Study and then follow these steps to import. Vault ignores the Last Login column during import.

Which permissions control your access depends on when your vault was created. If your vault uses the Role by Study feature, see the first section, Role by Study Permissions. If your vault does not use the CDMS Role by Study feature, see the second section, Profile Permissions.

Role by Study Permissions

Users with the Vault Owner security profile or the standard CDMS User Administrator application and the User Administration security profile can perform the actions described above by default. If your vault uses custom Application Roles, your role must have the following permissions:

Type Permission Label Controls
Functional Permission EDC Tools Tab

Ability to access the EDC Tools tab

Functional Permission Manage Users

Ability to create and edit Users and their access

Learn more about Study Roles.

Profile Permissions

Users with the Vault Owner and EDC Lead Data Manager security profiles can complete the actions described above.

If your vault uses custom security profiles, you must have a security profile with the following permissions:

Type Permission Controls
Security Profile EDC: Study Tools: Access Ability to access the EDC Tools area
Security Profile Objects: User: Create, Edit Ability to create new and edit existing Users
Security Profile Admin: Security: Users: Add Cross-Domain Users Ability to add Users from another domain into a vault

Learn more about permission sets.


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