Role actions are the ‘building blocks’ for rolesRoles. Each role action facilitates discrete functionality, and they can be assembled into roles Roles which are assigned to users to facilitate perform operational functions.
Role Action Details
Starting in ClinSpark version 1.5.0, users are now able to Users can export all the current configured Roles and Role Actions for a given environment. This is available to all users who have access to the Administration > Users component.
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Additionally, all Role Actions definitions can be reviewed using the ‘Role Action Overview’ modal, accessible to users when modifying an existing Role.
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Introduced in version 1.5.0. Provides access to the study Dashboard.
The role action also supports blinding requirements where users are expected only access specific areas of the application, but not see the study dashboard. Under blinded scenarios, users would not be given the ‘Dashboard’ role action.
This role action is also necessary for users to also access the components in Volunteers > Dashboard.
Overwhelmingly, most ClinSpark users are granted this role action so they can access the study Dashboard and other associated study components.
Study Data
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Writeable Actions
Each role action is identified with a property to determine if it is Writable. This indicates whether or not the role action will allow the user to make a modification of data through the user interface. The context on what is writable is based on the role action, however generally, if the role action allows a user to add, edit, or remove data it is writable. Role Actions that are intended to only allow ‘read only’ or limited capabilities in a component are otherwise identified as not writable.
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Table of Contents
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Dashboard
Provides access to the study Dashboard. Without this role action, users cannot access the Dashboard area.
The role action also supports blinding scenarios where users are setup and only expected to access specific areas of the application, but not see the study specific dashboard. Under these blinded scenarios, users would not be granted the ‘Dashboard’ role action.
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This role action is also necessary for users to also access the components in Volunteers > Dashboard.
Overwhelmingly, most ClinSpark users are granted this role action so they can access the study Dashboard and other associated study components.
Study Data
This activates the component menu item and allows access to basic features within Study > Data.
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Volunteer screens and an AE is collected into an unscheduled study event; screening number is S100
Volunteer has a screen fail
Volunteer returns for a second screening visit, and is later enrolled under a different subject record; screening number is S101
This role action would allow a qualified user to associate the AE collected under S100 to S101
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Study
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Data Move Form Data
Activates component menu item. When browsing study data with lab results, role action is required to view results.
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Study Lab Data Review
Allows a user to perform lab reviews.
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Study Lab Data Export
Allows for exporting study lab data; note Introduced in version 23.3.
Allows a user to move a form's data to different site, subject, or study event.
Accessible via Study > Data component.
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Reason for change values capture with ‘move’ workflows are visible within with Form Data Details audits.
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Study Lab Data
Activates component menu item. When browsing study data with lab results, role action is required to view results.
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Study Lab Data Review
Allows a user to perform lab reviews.
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Study Lab Data Export
Allows for exporting study lab data; note that user must also have the Study Report action assigned.
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Activates component menu item for Data Collection, and, access to Data Collection > Subject. Users with this role action can collect data.
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Data Collection Forms
Activates component menu item for Data Collection > Forms. Note that users must also have the ‘Data Collection’ role action assigned, otherwise the menu item will not be accessible.
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Data Collection Add Form
Allows user to add common and unscheduled form data.
From within a form…
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And from the data collection landing page…
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Data Collection Cancel
Allows user to cancel or uncancel form, item group, and item data.
Form level…
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Item Group level…
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And Item level…
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Data Collection - ICF Bypass
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Data Collection Forms
Activates component menu item for Data Collection > Forms. Note that users must also have the ‘Data Collection’ role action assigned, otherwise the menu item will not be accessible.
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Data Collection Add Form
Allows user to add common and unscheduled form data.
From within a form…
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And from the data collection landing page…
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Data Collection Cancel
Allows user to cancel or uncancel form, item group, and item data.
Form level…
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Item Group level…
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And Item level…
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Data Collection - ICF Bypass
For ICFs allowing bypass, allows user to bypass an ICF requirement with comment during data collection.
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CRF Design - Update Locked
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This role action allows a user to update certain locked study design entities within CRF Design > Study Library and CRF Design > Activity Plans.
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For components that allow for printing (sample packaging, application users, devices), this action will not limit the ability to print barcodes.
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Barcode Printing Manage
Introduced in version 1.5.0.
This gives users access to the features supporting self-serve barcode and label management in the Barcode Printing > Manage component. More details on those features are available in the Barcode Design & Printing guides.
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Samples Processing
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With access to the Review component, this role action allows a user to interact with study ‘interval’ ECGs.
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ECG Manage
Introduced in version 1.5.0.
This enables access to functionality intended for the management of study interval ECGs. This area of ClinSpark is only accessible if the study in question is configured for advanced ECG interval support, in support of E14 capabilities.
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Volunteers Calendar Assign
Introduced in version 1.5.0.
Supports Supports the ability for a user to assign a volunteer to a given calendar appointment.
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Volunteers Calendar Manage
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Supports the ability for users to add and modify calendar appointment details.
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Allows users to view a given volunteer’s health data, but not modify any existing data. In order to modify health data, users must also have the ‘Volunteers Manage Update Health’ role action assigned.
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Volunteers Monitoring
Introduced in version 1.5.0.
Allows users access to the ‘Monitoring’ tab within a given volunteer record.
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Volunteers Monitoring Manage
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Allows users to access and manage certain volunteer device monitoring sources, settings, and audits.
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Allows controls over saving and managing advanced searches. Without this role action, users will still be able to build and execute advanced search queries, but not save new searches or modify existing searches.
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Volunteers eConsent
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Allows access to the eConsent management area, to review and approve study specific eConsent requests.
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Users with this role action have access to the ‘Privacy Remove’ function on volunteer records. Details on this functionality can be reviewed in this article.
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Devices Manage
Activates component menu item, and allows users to review and manage site devices.
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Activates component menu item, and allows users to perform study design import/export.
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Approval Management
Allows users to manage approval requirements around study specific entities such as Activity Plans, ECG Interval Study Configurations, Eligibility Mappings, Informed Consents, Sample Paths, and Study Lab Panels.
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API
This is a unique role action that is typically assigned to ‘system’ accounts. It allows a user to leverage certain ClinSpark web services (such as APIs). Integration applications must be configured with this role action.export.
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Approval Management
Allows users to manage approval requirements around study specific entities such as Activity Plans, ECG Interval Study Configurations, Eligibility Mappings, Informed Consents, Sample Paths, and Study Lab Panels.
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API
This is a unique role action that is typically assigned to ‘system’ accounts. It allows a user to leverage certain ClinSpark web services (such as APIs). Integration applications must be configured with this role action.
Administration Users View API Tokens
Introduced in version 23.3.
Allows for read-only access to API tokens on a ClinSpark user profile. It will allow users to see all existing API token attributes, except token value.
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Administration Users Manage API Tokens
Introduced in version 23.3.
Allows for full access to API tokens, including the ability to add and modify existing tokens.
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Correspondence Call
Allows a user to perform calls to volunteers. This role action impacts call functionality present within volunteer profiles and on calendar components.
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