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Roles and Permissions Management

Introduction

Managing roles and permissions across multiple studies and modules has never been easier!
​Datacapt centralizes all roles and permissions in one intuitive place, ensuring seamless management for all your studies and activated modules.

In this article, we’ll cover everything you need to know about Roles & Permissions, so you can configure and manage them like a pro.

1. Definitions

Before diving into the configuration process, let’s define the key terms you need to know:

  • Role: A set of permissions grouped by main application modules.

  • Permission: A specific authorization to perform an action within the system.

  • User: A specific individual with access to Datacapt.

  • Platform - User Role: A role assigned to a user at the global platform level.

  • EDC Study - User Role: A role assigned to a user at the clinical study level within the EDC module.

These definitions outline the structure of roles and permissions in Datacapt, setting the foundation for effective configuration.

Configure Roles and Permissions

2. Review default Datacapt roles

When Datacapt is first configured and delivered, it includes 7 default roles to get you started.

How to access and review default roles:

  1. Navigate to "Settings" > "Roles" on the left-hand menu.

  2. Open an existing role using icon

  3. Expand each permission block to review the applied permissions:

    • Green indicates the permission is applied.

    • Blank indicates the permission is not applied.

Note: These default roles cannot be modified.

Roles - View.gif

3. Create custom roles

If the default roles do not align with your clinical project’s needs, you can create custom roles tailored to your organization.

How to create custom roles:

  1. Navigate to "Settings" > "Roles" on the left-hand menu.

  2. Select "+ Add New Role".

  3. By default, all permissions are deactivated.

  4. Expand each permission block and apply the necessary permissions.

  5. Click Save to finalize your custom role.

How to modify a custom role:

  1. Navigate to "Settings" > "Roles" on the left-hand menu.

  2. Open the role you want to modify using the icon

  3. At the top, select "Edit".

  4. Apply the necessary changes to the permissions.

  5. Click Save to update the role.

Note: Changes to a role are reflected live and automatically apply to all users assigned to that role within a given study.

Roles - Custom.gif

4. Role Assignement Hierarchies

For users with access to User Management—whether at the platform or study level—it is possible to assign roles to other users. Additionally, you may need to limit a role’s capacity to assign or upgrade other roles (e.g., restricting a specific role from upgrading users to "Admin").

How to configure role assignement hierarchies :

  1. Navigate to "Settings" > "Roles" on the left-hand menu.

  2. Open the desired role using the icon

  3. At the top, select "Edit"

  4. Expand the "Role Assignment Restrictions" block

  5. Choose which roles this role is allowed to assign

  6. Click Save to apply the settings

Note: By default, only users assigned to the "ADMIN" role (the default Datacapt local admin role) can upgrade another user to "ADMIN".

Roles - Hierarchie.gif

Default Roles & Permissions

These tables lists every permission in Datacapt and which of the seven default roles hold it out of the box. A ✅ means the role has the permission by default. Administrators can adjust these grants or create custom roles under Settings → Roles.
​

Role abbreviations:
​

  • Admin = Administrator

  • PM = Project manager

  • DM = Data manager

  • Inv = Investigator

  • Mon = Monitor

  • Aud = Auditor / Sponsor

  • MI = Main investigator

The Administrator role always holds every permission, including any added in future releases.

Permission

Description

Admin

PM

DM

Inv

Mon

Aud

MI

GLOBAL SETTINGS

Global user management

Access

Open the tenant-wide user list

✅

–

–

–

–

✅

–

Invite

Invite new users to the platform

✅

–

–

–

–

–

–

Edit

Edit user details and roles

✅

–

–

–

–

–

–

Delete

Delete user accounts

✅

–

–

–

–

–

–

Unblock

Reactivate a blocked user account

✅

–

–

–

–

–

–

Block

Block (lock) a user account

✅

–

–

–

–

–

–

Invite all

Invite users with access to all studies / projects at once

✅

–

–

–

–

–

–

General settings

Edit

Edit tenant-wide general settings (incl. participant status labels)

✅

–

–

–

–

–

–

Subject consents

Edit

Edit tenant-wide subject consent configuration

✅

–

–

–

–

–

–

Roles

Edit

Create and edit roles and their permissions

✅

–

–

–

–

–

–

Centers

Access

View the centers list

✅

–

–

–

–

✅

✅

Edit

Create and edit centers

✅

–

–

–

–

–

✅

Templates

Access

View form / study templates

✅

–

✅

–

–

–

✅

Delete

Delete templates

✅

–

✅

–

–

–

✅

Audit trails (global)

Access

View the tenant-wide audit trail

✅

–

–

–

–

✅

–

Export

Export the tenant-wide audit trail

✅

–

–

–

–

✅

–

API credentials

Access

View and manage API keys

✅

–

–

–

–

–

–

Customization

Edit

Edit tenant branding / customization

✅

–

–

–

–

–

–

STUDY

Study list

Add

Create a new study

✅

✅

✅

–

–

–

✅

Draft study

Access all

Access all draft studies with all permissions

✅

–

✅

–

–

–

✅

STUDY ADD-ONS

Participant status

Edit

Change a subject's participant status

✅

✅

–

✅

–

–

✅

Analytics

Access

View study analytics dashboards

✅

✅

✅

✅

✅

–

✅

Edit

Configure analytics dashboards

✅

✅

✅

–

–

–

✅

Export

Export analytics data

✅

✅

✅

✅

–

–

✅

Document management

Access

View study documents

✅

✅

✅

✅

✅

✅

✅

Upload

Upload documents

✅

✅

✅

✅

✅

–

✅

Delete

Delete documents

✅

✅

✅

✅

✅

–

✅

Edit

Edit document metadata / folders

✅

✅

✅

–

–

–

✅

Subject management

Access

View the subject list

✅

✅

–

✅

–

–

✅

Add

Add subjects

✅

✅

–

✅

–

–

✅

Edit

Edit subject details

✅

✅

–

✅

–

–

✅

Translations

Access

View study translations

✅

✅

✅

–

–

–

✅

Edit

Edit study translations

✅

✅

✅

–

–

–

✅

Study audit trails

Access

View the study audit trail

✅

✅

✅

✅

✅

✅

✅

Export

Export the study audit trail

✅

–

–

–

✅

✅

✅

Automation

Access

View / use study automations

✅

✅

✅

✅

–

–

✅

Study user management

Access

View study team members

✅

✅

–

–

–

✅

✅

Invite

Invite users to the study

✅

✅

–

–

–

–

✅

Edit

Edit study members' access

✅

–

–

–

–

–

–

Delete

Remove users from the study

✅

✅

–

–

–

–

✅

Study settings

Edit

Edit study settings

✅

✅

✅

–

–

–

✅

Randomization configuration

Access

View randomization configuration

✅

✅

✅

–

–

–

✅

Edit

Edit randomization configuration

✅

✅

✅

–

–

–

✅

Delete

Delete randomization configuration

✅

✅

✅

–

–

–

✅

Randomization list

Access

View the randomization list

✅

–

–

–

–

–

–

Edit

Edit randomization list entries

✅

–

–

–

–

–

–

Unblind access

View unblinded randomization data

✅

–

–

–

–

–

–

Kit inventory

Access

View the kit inventory

✅

–

–

–

–

–

–

View kit type

See kit types (unblinding-sensitive)

✅

–

–

–

–

–

–

View subject ID

See subject IDs on kits

✅

–

–

–

–

–

–

Edit

Edit kit inventory

✅

–

–

–

–

–

–

Allocation configuration

Access

View allocation configuration

✅

–

–

–

–

–

–

Edit

Edit allocation configuration

✅

–

–

–

–

–

–

Allocation

Add

Allocate subjects

✅

–

–

–

–

–

–

Edit

Edit allocations

✅

–

–

–

–

–

–

ECRF

eCRF builder

Edit

Build and edit eCRF forms

✅

–

✅

–

–

–

✅

eCRF record list

Access

View the eCRF record list

✅

✅

✅

✅

✅

✅

✅

Add

Create new records

✅

–

✅

✅

–

–

✅

Archive

Archive records

✅

✅

✅

✅

–

–

✅

Export

Export record data

✅

✅

✅

✅

–

✅

✅

eCRF records

Access

Open and view record data

✅

✅

✅

✅

✅

✅

✅

Edit

Enter and edit record data

✅

–

✅

✅

–

–

✅

Add queries

Raise data queries

✅

–

✅

–

✅

–

✅

Resolve queries

Answer / resolve queries

✅

–

✅

✅

✅

–

✅

Close queries

Close queries

✅

–

✅

–

✅

–

✅

Sign

Electronically sign records

✅

–

✅

✅

–

–

✅

Lock

Lock records against changes

✅

–

–

–

✅

–

✅

Exclude

Exclude a subject

✅

–

✅

✅

–

–

✅

Review

Mark data as reviewed

✅

–

–

✅

✅

–

✅

SDV

Perform source data verification

✅

–

–

✅

✅

–

✅

Emergency unblind

Perform an emergency unblinding

✅

–

–

–

–

–

✅

eCRF files

Export

Download files attached to eCRF records

✅

✅

✅

✅

–

–

✅

Monitoring

Access

View the monitoring dashboard

✅

✅

✅

✅

✅

✅

✅

EPRO

ePRO dashboard

Access

View the ePRO dashboard

✅

✅

✅

✅

✅

✅

✅

Add

Create ePRO surveys

✅

✅

✅

–

–

–

✅

ePRO record list

Access

View ePRO records

✅

✅

✅

✅

✅

✅

✅

Archive

Archive ePRO records

✅

✅

–

✅

–

–

✅

Add

Add ePRO records

✅

✅

–

✅

–

–

✅

Export

Export ePRO data

✅

✅

✅

✅

–

–

✅

Generate link

Generate participant survey links

✅

–

✅

✅

–

–

✅

Edit

Edit ePRO records

✅

–

–

✅

–

–

✅

ePRO builder

Edit

Build and edit ePRO surveys

✅

✅

✅

–

–

–

✅

ePRO settings

Access

View / manage ePRO settings

✅

✅

✅

–

–

–

✅

ePRO files

Export

Download files attached to ePRO records

✅

✅

✅

✅

–

–

✅

ECONSENT

eConsent dashboard

Access

View eConsent forms and statuses

✅

✅

✅

✅

✅

✅

✅

Add

Create eConsent entries

✅

–

–

✅

–

–

✅

Archive

Archive eConsent forms

✅

✅

✅

✅

–

–

✅

Export

Export eConsent data

✅

–

–

–

–

–

✅

eConsent signature

Access

View signature status / signed documents

✅

✅

–

✅

✅

–

✅

Sign

Countersign consents

✅

–

–

✅

–

–

✅

eConsent builder

Edit

Build and edit eConsent forms

✅

–

✅

–

–

–

✅

ECONSULT

eConsult

Access

Access video consultations

✅

–

–

✅

–

–

✅

ANALYSIS

Data analysis

Access

View data analysis workspace

✅

✅

✅

✅

–

✅

✅

Upload

Upload datasets

✅

✅

–

✅

–

–

✅

Refresh

Refresh analysis data

✅

✅

–

✅

–

–

✅

Export

Export analysis results

✅

✅

✅

✅

–

✅

✅

SUBJECT DATABASE

Subject repository

Access

View the subject repository

✅

–

–

–

–

–

–

Add

Add subjects to the repository

✅

–

–

–

–

–

–

Edit

Edit repository subjects

✅

–

–

–

–

–

–

Answer

Fill in repository forms

✅

–

–

–

–

–

–

Basic settings

Edit repository basic settings

✅

–

–

–

–

–

–

Repository builder

Access

Access the repository form builder

✅

–

–

–

–

–

–

Repository campaigns

Add

Create outreach campaigns

✅

–

–

–

–

–

–

Repository actions

Import

Import subjects

✅

–

–

–

–

–

–

Export

Export subjects

✅

–

–

–

–

–

–

Bulk delete

Bulk-delete subjects

✅

–

–

–

–

–

–

Delete

Delete a subject

✅

–

–

–

–

–

–

RECRUITMENT

Recruitment

Access

View recruitment studies

✅

–

–

–

–

–

–

Add

Create recruitment studies / participants

✅

–

–

–

–

–

–

Edit

Edit recruitment data

✅

–

–

–

–

–

–

Recruitment builder

Edit

Build recruitment forms

✅

–

–

–

–

–

–

Recruitment records

Invite

Invite participants

✅

–

–

–

–

–

–

Export

Export recruitment records

✅

–

–

–

–

–

–

CALENDAR

Calendar

Access

View calendars and schedules

✅

–

–

–

–

–

–

Add

Create events / schedules

✅

–

–

–

–

–

–

Edit

Edit events / schedules

✅

–

–

–

–

–

–

Delete

Delete events / schedules

✅

–

–

–

–

–

–

Visit

Update

Update visit status / details

✅

–

–

–

–

–

–

PAYMENTS

Payments

Access

View stipend payment settings

✅

–

–

–

–

–

–

Edit

Edit payment settings

✅

–

–

–

–

–

–

Export

Export payment data

✅

–

–

–

–

–

–

Payment orders

Access

View payment orders

✅

–

–

–

–

–

–

Edit

Edit payment orders

✅

–

–

–

–

–

–

Export

Export payment orders

✅

–

–

–

–

–

–

REPORTS

Reports

Access

View reports

✅

–

–

–

–

–

–

Edit

Create and edit reports

✅

–

–

–

–

–

–

Good to know

  1. Administrator has everything. The Admin role is granted every permission automatically, it can never lack one.

  2. Admin-only modules. Subject repository, Recruitment, Calendar, Payments, Side-by-side and Reports currently have no default grants for non-admin roles. The same applies to Randomization list, Kit inventory and Allocation. Grant these to other roles via a custom role or by editing the role's permissions.

  3. Role assignment. An Administrator can assign any role, including Administrator. Users with any other role can assign any role except Administrator.

  4. Custom roles. You can create your own roles with any combination of these permissions. Editing roles requires the Roles: edit permission (Administrator only by default).

  5. Draft studies. The Draft study: access all permission grants all permissions inside any unpublished (draft) study, this is why Data managers and Main investigators can fully build studies before launch.

Frequently Asked Questions

Is it possible to duplicate roles ?

Currently, it is not possible to duplicate roles in the existing version of Datacapt.
However, stay tuned—this feature may be available in future updates!

How to test roles ?

Testing roles is simple! To do this, create a test user by using an email alias, such as myname+test@mail.com , and assign the desired role to the test user.

Open an incognito window and log in with the test account to check the permissions.

If a permission is incorrect, switch to your admin account, modify the role, and save your changes. Since changes to roles are applied live, simply reload the incognito page and test again to verify the updates immediately.

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