Editing user permissions
✋ The feature to edit user permissions is available only for Red Pill version 26 and later.
IN THIS ARTICLE
Editing user permissions
To edit user permissions or create a new customised role, go to the ‘User permissions’ section on the Specification or Settings page, and click on the Edit user permissions button.
You can grant or remove permissions by ticking or unticking the relevant box. Remember to save your changes by clicking on the Save changes button at the bottom of the permissions list.
User permissions are grouped according to the tasks or features they relate to (e.g. admin, CRF, randomisation, etc).
Depending on your trial characteristics (e.g. blinded or unblinded), certain permissions may not be available, and they will not be shown in the Specification for your trial.
Additionally, certain permissions may be applicable or not depending on other permissions. If a permission is not applicable, you will not be able to grant it, as the tick box will be greyed out. For example, 'Edit CRF' is not applicable unless the role has 'View CRF' permission.
You will also find that some permissions are not editable, so you will be able to view them but not edit them. For example, 'Participant access to fill in forms' is a non-editable permission.
It is important to note that some permissions are not limited by site and give the user access to data at all sites, such as the 'View audit log' permission. These are marked with a yellow 'All data' label. We recommend you avoid giving these permissions to Investigator and other roles that are normally limited by site.
Some permissions reveal the true treatment group to the user, such as the 'Download the application archive' permission. These are marked with a yellow 'Treatment' label. The ability to view the treatment group varies by whether the randomisation system is blinded or unblinded. Blinded systems hide the treatment group in most cases, so it is not currently possible to create unblinded roles in blinded systems.
Warning: Archives may contain sensitive data such as randomisation lists and unblinded data. Think carefully about the risks before assigning permission to download archives to any role involved in the day-to-day running of the study.
When a user requires permissions typically associated with several different roles, we generally recommend that you assign this person multiple roles rather than creating one very customised role just for them.
Available permissions
Admin
These permissions are related to data management tasks and are usually relevant for administrators.
| Permissions | Notes |
| View reports | This permission gives the user access to data across all sites. In unblinded trials, it reveals the true treatment group to the user; therefore, it cannot be granted unless 'View the treatment group' is granted. |
| View the specification | |
| View and change settings and user permissions | This permission is not editable. |
| View the audit log | This permission gives the user access to data across all sites. In unblinded trials, it reveals the true treatment group to the user; therefore, it cannot be granted unless 'View the treatment group' is granted. |
| Download the audit log | This permission gives the user access to data across all sites. In unblinded trials, it reveals the true treatment group to the user; therefore, it cannot be granted unless 'View the treatment group' is granted. This permission cannot be granted unless ‘View the audit log’ is granted. |
| Download form data |
This permission gives the user access to data across all sites. |
| Download the application archive | This permission gives the user access to data across all sites. It also reveals the true treatment group to the user in both blinded and unblinded trials, as the downloaded archive contains randomisation and/or code lists. This permission needs to be removed in order to 'blind' a role. |
| View listing of overdue forms |
CRF
These permissions are related to access to the CRF and are usually relevant for investigators.
| Permissions | Notes |
| View forms |
|
| Add forms |
This permission cannot be granted unless ‘View forms’ is granted. |
| Edit forms |
This permission cannot be granted unless ‘View forms’ is granted. |
| Delete forms | This permission cannot be granted unless ‘View forms’ is granted. |
| View Personally Identifiable Information (PII) | If the CRF contains PII fields, this permission allows users to view the data in these fields. They may also enter data into PII fields provided they have the 'Add forms' permission. |
Code list
These permissions are related to viewing and managing the code list and are usually relevant for administrators and pharmacy roles. They will be available for blinded trials with the code list management feature.
| Permissions | Notes |
| View the code list | View the blinded code list |
| Edit the code list |
This permission cannot be granted unless ‘View code list’ is granted. |
| Display the treatment group |
Unblinds the code list by showing the treatment group. This permission cannot be granted unless ‘View code list’ is granted. Introduced in Red Pill 29.1.0 |
Participant
These permissions are related to managing participants.
| Permissions | Notes |
| View participants |
This permission allows you to view participants' details and the CRF overview. If you remove this permission but CRF-related permissions are granted, the forms may be accessible through relevant reports (e.g. Completed forms, Overdue forms, etc.) and through queries. You should remove report and query permissions to prevent any access to forms in the CRF. |
| Delete participants | This permission cannot be granted unless ‘View participants’ is granted. |
| Mark data missing |
This permission cannot be granted unless ‘View participants’ is granted. |
| Upload attachments | This permission is not shown unless participant attachments are enabled. |
| Delete attachments | This permission is not shown unless participant attachments are enabled. |
| View and download attachments | This permission is not shown unless participant attachments are enabled. |
Participant invites (ePRO)
These permissions are related to inviting participants to complete forms. They will not be available for trials without ePRO forms.
| Permissions | Notes |
| View invite schedule |
This permission cannot be granted unless ‘View participants’ is granted. |
| Invite participants to complete forms |
This permission cannot be granted unless ‘View participants’ is granted. |
| Send manual invitations for visits |
This permission cannot be granted unless ‘View participants’ is granted. |
| Participant access to fill in forms (ePRO) |
This permission is not editable. |
Queries
These permissions are related to managing queries.
| Permissions | Notes |
| View queries | |
| Create queries | This permission cannot be granted unless ‘View queries’ is granted. |
| Edit queries | This permission cannot be granted unless ‘View queries’ is granted. |
| Change query status | This permission cannot be granted unless ‘Edit queries’ is granted. |
Randomisation
These permissions are related to randomisation. They will not be available for trials without randomisation.
| Permissions | Notes |
| View the treatment group | This permission reveals the true treatment group to the user. It only applies to unblinded trials, where it can be removed to hide the treatment group in order to 'blind' a role. It controls whether the treatment group is shown on the participant list, on screen after randomisation, in notification emails and in downloads (randomisation form). |
| Assign a kit from the code list to a randomised participant |
Only applies to blinded trials where code list management has been enabled. |
| View unblindings |
Only applies to blinded trials where the unblinding feature has been enabled. |
| Unblind the treatment for a randomised participant |
This permission cannot be granted unless ‘View unblindings’ is granted. |
| Mark a randomisation as randomised in error |
|
| Record manual randomisations |
Available from Red Pill 32 onwards |
Shipments
These permissions are related to managing stock shipment. They are available for blinded trials with the automatic site restocking feature.
| Permissions | Notes |
| Manage distributors | When you grant this permission, make sure that 'View sites' is also granted (see below); otherwise distributors cannot be accessed. 'Edit sites' needs to be granted too in order to add a distributor to a site. |
| Cancel shipments | When you grant this permission, make sure that 'View sites' is also granted (see below); otherwise the shipment cannot be accessed. |
| Download shipment dispatch notes | When you grant this permission, make sure that 'View sites' is also granted (see below); otherwise the shipment cannot be accessed. |
| Mark shipments received | When you grant this permission, make sure that 'View sites' is also granted (see below); otherwise the shipment cannot be accessed. |
| Create manual shipments | When you grant this permission, make sure that 'View sites' is also granted (see below); otherwise the Site page cannot be accessed to create the manual shipment. Additionally, 'Edit code list' also needs to be granted in order to allocate kits to the distributor. |
| Set re-stock ratios | This permission may allow a user to glean some limited unblinded information regarding treatments in stock at a site by changing the re-stock ratios. |
Site management
These permissions are related to managing sites.
| Permissions | Notes |
| View sites | |
| Add sites | This permission cannot be granted unless ‘View sites’ is granted. |
| Edit sites | This permission cannot be granted unless ‘View sites’ is granted. |
| Delete sites | This permission cannot be granted unless ‘View sites’ is granted. |
Uploads
These permissions are related to importing data into the app.
| Permissions | Notes |
| Import CRF data from uploaded CSV files | |
| Import randomisation and code list from uploaded CSV files | This permission reveals the true treatment group to the user. In unblinded trials, it requires the 'View treatment group' permission. |
Form permissions
👀 Form permissions are visible in Red Pill version 29 and later.
Access to individual forms are shown by role. Most roles will have access to all forms in the CRF by default unless your trial has been customised. Some roles, such as Randomisation and Unblinding, will be limited to the randomisation form by default.
Implied permissions
These are permissions that are related to specific forms in the CRF (such as study entry and withdrawal forms). It's not possible to directly edit these permissions, but they may be affected by customised access to the related forms.
| Permissions | Notes |
| Enrol participants into the trial | In trials with a participant entry form, this permission is implied when ‘Add forms’ is granted. |
| Randomise | In trials with randomisation, this permission is implied when ‘Add forms’ is granted. |
| Withdraw participants | In trials with a field designated as date of withdrawal, this permission is implied when ‘Add forms’ is granted. |
Adding/deleting a new role
Users with the 'View and change settings and user permissions' can create a new role with customised permissions. To do this, first click on the Edit user permissions button and then on the Add a role button. A new column will be shown where the name of the role can be entered in the box provided.
To delete or rename a role click on the column heading or use the buttons that show up when hovering over the column. If you delete a role that has already been assigned to users, their access with that role will be suspended. Note that it is not possible to delete or rename the administrator role.