Define user rights in EDC/CDMS
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In the 'Users' tab, double clicking on a user's name or clicking the cogwheel icon in the 'Action' column provides an overview of the assigned rights for the selected user.
Rights in Castor are assigned on the site level. That means that a user can have different rights in one or multiple sites.
- User rights can be edited for each site listed in the left-most column.
- You can choose one of the pre-defined roles or create your own roles to assign rights quickly and to blind parts of the CRF.
- The participant rights for the selected user per site, which are as follows:
- Add: Allows the user to create new participants. To add a participant, you also need a 'View' right.
- View: Allows the user to view and print participants, view and respond to queries and comments, download the uploaded files.
- Edit: Allows the user to enter and edit data in a participant, import study and repeating data data. Adding repeating data also requires Edit rights.
- Email: Allows the user to view and/or edit the stored email address within a participant or within a survey invitation To be able to edit a participant's email address it is also necessary to have ‘Edit’ rights.
- Rand. (randomize): Allows the user to randomize participants.
- View rand. (view randomization): Allows the user to view the randomization allocation for a participant.
- Sign: Allows the user to digitally sign study forms.
- Lock: Allows the user to lock participants, preventing further data entry, as well as to unlock participants.
- Verify: Allows the user to do source data verification of data entry.
- Query: Allows the user to create and close queries (used for monitoring).
- Archive: Allows the user to archive and un-archive participants.
- Export: Allows the user to export data. To be able to export participants, you need both 'View' and 'Export' rights.
- Send surveys: Allows the user to create and send survey invitations as well as create and manage groups for bulk invites.
- View surveys: Allows the user to view and enter survey data
- Encrypt: Allows users to view and edit encrypted data.
- Decrypt: Allows users to edit encrypted data.
If your study has never been live and you would like to delete participants, you need to have 'Archive' and 'Edit' rights. Users with site rights only can enter a study if it is live.
4. Click the 'Save' button to save changes. Alternatively, click 'Close' to discard any changes and return to the 'User' overview.
You can check each right description in the information text for all site and manage rights.
The management rights are advanced rights for users that are managing the study, in contrast to only performing data entry. These rights provide access to the study management related tabs.
Open the 'User rights' dialog window by double clicking on the user's name or by clicking the cogwheel icon in the action column next to a user.
To change the management rights, click the 'Management rights' tab at the top:
- Management rights can be changed using the Yes/No radio buttons next to the specific management right. The management rights are as follows:
- Participants: If a user has the 'Manage participants' right, they will see the 'Participants', ‘Reports’ and 'Surveys' tab. The exact data the user can access depends on the specific site rights. For example, a user who needs to view the participants for 'site X' will need to have 'Manage participants' and 'View' rights for 'site X'. To create and modify participant groups (for the survey bulk invitations) the 'Manage participants' right is needed.
- Forms: Allows the user access to study management tab 'Structure' and 'Form' (the Form Builder) to create, edit and export/import forms.
- Users: Allows the user access to study management tab 'Users'.
- Settings: Allows the user access to study management tab 'Settings'.
- Click 'Save' to save the changes, or 'Close' to discard changes, and return to the 'User' overview.
- To view the Audit Trail, all management rights must be enabled.
- Users with 'Mange participants' rights but without 'View' rights for specific sites can still see some aggregated/summarized data in the 'Statistics' tab for all sites, as well as for individual sites. They won't be able to view the data itself when accessing 'participants', 'repeating datas', 'Surveys' or 'Monitoring' tabs.
User role deviations in the Rights overview
Changing permissions on an already assigned role will not also update the effective user rights, which can lead to confusion and potentially errors in the needed/final user permissions. It is possible to generate an overview of the role deviations by clicking on the ‘Rights overview’ button in the ‘Users’ tab.
All user rights that deviate from the set of user rights defined for a specific user role are highlighted in the rights overview.