Role actions are the ‘building blocks’ for roles. Each role action facilitates discrete functionality, and they can be assembled into roles which are assigned to users to facilitate operational functions.
Role Action Details
Starting in ClinSpark version 1.5.0, users are now able to 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.
This export contains a Role Action tab with a name and description about each available Role Action in the system.
Additionally, all Role Actions definitions can be reviewed using the ‘Role Action Overview’ modal, accessible to users when modifying an existing Role.
Dashboard
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
This activates the component menu item and allows access to basic features within Study > Data.
Study Data Save Annotations
This role action was deprecated in ClinSpark version 1.4.0. It was previously related to the ability to add annotations to Item data from within the Study > Data component.
In current releases, Item annotations are now collected within form data collection workflows, via Item menu Action > Annotations.
Study Data Lock
Supports locking study data at various levels. More details on this process are in the Database Locking Guide.
At the Item level…
The Form level…
The Study Event level…
And the Subject level…
Study Data Export
Allows for exporting study data; note that user must also have the Study Report role action assigned.
Study Data Reassignment
Allows for a user to re-assign common / unscheduled study event data for a given volunteer from one subject record to another. It is intended for rare scenarios where a given volunteer has (accidentally) two or more subject records for a study, and there is a need to re-associate study event data.
Consider the given hypothetical:
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
Study Lab Data
Activates component menu item. When browsing study data with lab results, role action is required to view results.
Study Lab Data Review
Allows a user to perform lab reviews.
Study Lab Data Export
Allows for exporting study lab data; note that user must also have the Study Report action assigned.
Study Subjects
Activates component menu item, and read-only access to study subject details and audits.
Study Subjects Edit
Allows user to update subject numbers and status.
In batch…
And individually
Study Subjects AE / CM Management
Allows for the management of AE / CM from within the Subject component.
Study Subjects Assessments
Allows for the management of assessments from within the Subject component.
In batch…
And individually…
Study Subjects Informed Consent
Allows for subject-based management of informed consent.
Study Subjects Inclusion / Exclusion
Allows for subject-based management of inclusion / exclusion criteria.
Study Subjects Over-Volunteering
Allows for subject-based management of over-volunteering.
Study Queries
Allows for viewing of queries.
Study Queries Create
Users with this role action will be able to create queries.
Study Queries Respond
Introduced in version 1.5.3.
Users with this role action will be able to respond to queries.
Study Queries Manage
Users with this role action will be able to supersede any query specific settings, other than query specific ‘view’ role restrictions. If a user is not authorized to view a query based on applied role restrictions, this role action will not give them access to those query settings.
Assuming however that users with this role action are able to view a given query, they will also have the capability to update the query settings.
Study Reviews
This role action ensures that only users assigned as study reviewers will be able to perform reviews.
Study Report
Activates component menu item and access to reports. Individual reports that appear in this component can be further configured to require certain role and role action permissions (via Administration > System Settings).
Study Report (Data Managing)
This is a ‘legacy’ role action that is non-writable. It is currently under review for removal in a future release.
It’s original purpose was to restrict access to certain reports for data management purposes. However, current versions of ClinSpark offer more flexible controls to manage role / role action restrictions across users and system configurations (such as reports and dashboards). While by name it implies use for reports for Data Management workflows, the role action can be applied to any configuration type.
Study Activity
Activates component menu item.
Study Cohort Assignment Manage
Allows a user to create, update, and delete cohort assignments. In order for users to be able to this action, they must also have the Administration Studies role assigned.
Adding…
Updating…
And deleting…
Study Cohort Assignment Swap
Allows a user to swap one cohort assignment into another. In order for users to be able to this action, they must also have the Administration Studies role assigned.
Study Cohort Assignment Activate
Allows a user to activate an activity plan / volunteer for cohort assignments. In order for users to be able to navigate to this action, they must also have the Administration Studies role assigned.
Activate plans in batch…
Activate individual plan…
Activate volunteers in batch…
And activate individual volunteer…
Study Design Accessible
Allows a user to interact with studies in a Design state.
Study User Management
Introduced in version 1.5.3.
Allows a user to manage user restrictions for a given study. Additionally, users with this role action also do not need to be explicitly added to the study in question.
Note: For customers on ClinSpark version 1.5.4 or greater, users must also have the ‘Administration Users Manage’ role action assigned in order to access the study specific User Access features.
Data Collection
Activates component menu item for Data Collection, and, access to Data Collection > Subject. Users with this role action can collect data.
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.
Data Collection Add Form
Allows user to add common and unscheduled form data.
From within a form…
And from the data collection landing page…
Data Collection Cancel
Allows user to cancel or uncancel form, item group, and item data.
Form level…
Item Group level…
And Item level…
Data Collection - ICF Bypass
For ICFs allowing bypass, allows user to bypass an ICF requirement with comment during data collection.
To bypass ICF requirements during data collection, a subject must have signed an ICF that is not inactive and marked with the “Allow Bypass” settings
Data Collection - Subject Barcode Scan Bypass
Allows for bypassing subject barcode verification requirements on configured forms that are not in an Unsaved state.
Data Collection Unscheduled Update
Allows user to update details on unscheduled forms
Data Collection Enrollment
Introduced in version 1.5.2.
This allows users access to the ‘Enroll’ button within Data Collection, which supports enrolling a new subject into a study when the global advanced system setting ‘volunteer support’ is disabled.
Prior to this change, the ‘Study Cohort Assignment Activate’ role action was used for these types of subject enrollment workflows.
When customers upgrade to the latest version ClinSpark, an automated database migration will add the this ‘enrollment’ role action to all roles that previously have ‘Study Cohort Assignment Activate’, so that customers do not need to manually make this update for roles in their environment.
CRF Design Study Library
Activates component menu item. Allows a user to manage with study library / metadata.
CRF Design Activity Plans
Activates component menu item. Allows a user to manage with study activity plans.
CRF Design Activity Plan Redesign
Allows a user to perform updates to plans after they have been locked.
CRF Design - Update Locked
Introduced in version 1.5.0.
This role action allows a user to update certain locked study design entities within CRF Design > Study Library and CRF Design > Activity Plans.
Activity Plans
Users are unable to perform the following actions within locked Activity Plans without this role action:
Modifying activity plan configuration or locked state
Individual scheduled activities cannot modified or deleted
Activity plan segments cannot be modified, copied, or deleted
Study Library
Users are unable to perform the following actions within Study Library without this role action:
Editing study metadata
Editing or unlocking study events in locked state
Adding or deleting aliases within locked study events
Editing or unlocking forms in locked state
Editing item group references within locked forms
Adding or deleting aliases within locked forms
Editing an item group in locked state
Editing item references within locked item group
Adding or deleting default item groupings within locked item groups
Adding or deleting aliases within locked item group
Editing an item in a locked state
Adding, modifying, or deleting edit checks within locked items
Adding or deleting aliases within locked items
Editing code lists in locked state
Adding or editing code list items within locked code lists
Editing or deleting aliases within locked code lists
Barcode Printing
Activates component menu items Barcode Printing > Labels and Barcode Printing > Subjects.
For components that allow for printing (sample packaging, application users, devices), this action will not limit the ability to print barcodes.
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.
Samples Processing
Activates component menu item and access to samples processing functionality.
Samples Intervals
Activates component menu item and review samples interval void containers.
Samples Intervals Manage
Allows user to add / manage void containers and perform weighing summary.
Samples Packaging
Activates component menu item and access to samples packaging capabilities.
Managing packages (containers)…
And managing shipments…
In order to add and save containers, and, add containers to locations users must also have the Samples Configure role action.
Samples Manage
Activates component menu item and access to features supporting the review of samples lifecycle. Users with this role action will be able to view sample annotations and audits.
Samples Update
Allows user to make updates and store annotations to collected sample data.
Samples Configure
Activates component menu item, and allows a user to manage sample pathway configurations.
Lab Orders
Activates component menu item, and allows users to view lab data.
Lab Ordering
Introduced in version 1.5.3.
Allows users to explicitly perform actions within the Lab > Orders component such as putting a specimen on hold or re-posting orders.
Lab Repeat
Activates component menu item, and allows users to review and manage repeat lab requests.
Lab Configure
Activates component menu item, allowing users to manage study specific lab configurations.
Lab LIMS Print
Activates component menu item, and allows a user to print lab labels.
Lab Edit
Allows a user to add or modify study lab results.
ECG
This role action enables access to various ECG features, and is intended to be used with additional ‘ECG’ role actions. On it’s own it activates no visible functionality. However when combined with additional Review, Manage, and Configure role actions it allows users further access to those ECG menu components and features.
ECG Review
This role action allows users access to the component menu item. However, in order to perform interval or assessment ECG reviews, those separate required role actions must be configured. These will be further driven by study specific configurations.
Depending on the study ECG configuration and additional role actions assigned, users will be prompted to support an ECG review type.
ECG Review Assessment
With access to the Review component, this role action allows a user to interact with study ‘assessment’ ECGs.
ECG Review Intervals
With access to the Review component, this role action allows a user to interact with study ‘interval’ ECGs.
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.
ECG Configure
This activates component menu item, and allows a user to configure study specific ECG settings.
Medical Coding
Activates component menu item, and allows a user to perform medical coding.
Component menu…
And medical coding of terms…
Medical Coding Configure
Activates component menu item, and allows a user to configure study specific medical coding groups.
Menu component…
And configuration…
Volunteers Dashboard
Activates component menu item, and allows user to view recruitment dashboard components. Note that users must also have the ‘Dashboard’ role action assigned in order to interact with components in this area of ClinSpark.
Volunteers Recruit
Activates component menu item, and allows user to review identified study volunteers and fill out recruitment questionnaires.
Component menu…
Bulk identification…
Individual identification…
And identification against study eligibility…
Volunteers Recruit - Manage
Allows user to manage recruitment settings.
Volunteers Calendar
Activates component menu item, and allows users access to view existing calendar appointments.
Volunteers Calendar Assign
Introduced in version 1.5.0.
Supports the ability for a user to assign a volunteer to a given calendar appointment.
Volunteers Calendar Manage
Introduced in version 1.5.0.
Supports the ability for users to add and modify calendar appointment details.
Without this role action, users are only able to view existing calendar appointments, and, view appointment audits.
Volunteers Manage
Activates component menu item. Allows users the ability to search volunteer database, add and delete advanced searches, and access volunteer profiles. From within volunteer profile, users can view volunteer barcode and audits.
Volunteers Manage Upload
This role action has been deprecated and the related feature replaced by volunteer recruitment website API capabilities. In a future release, the role action will be fully removed from the application.
Volunteers Manage Export
Allows a user to export volunteer data.
Volunteers Manage Update
Allows a user to add new volunteers to the database, and update general volunteer profile data and images.
General details…
And image…
Volunteers Manage Update Banking
Allows a user to view and update volunteer banking data.
Volunteers Manage Update Health
Allows a user to view and update volunteer health data.
Volunteers Manage Medications Add
Allows a user to add medications to a volunteer record.
Volunteers Manage Medications Update
Allows a user to update medications for a volunteer record.
Volunteers Manage Medical History Add
Allows a user to add medical history to a volunteer record.
Volunteers Manage Medical History Update
Allows a user to modify medical history data for a volunteer record.
Volunteers Manage Substance Use Add
Allows a user to add substance use data to a volunteer record.
Volunteers Manage Substance Use Update
Allows a user to update substance use for to a volunteer record.
Volunteers Manage Correspondence Add
Allows a user to add correspondence messages to a volunteer record.
Volunteers Manage Notes Add
Allows a user to add notes to a volunteer record.
Volunteers Manage Notes Update
Allows a user to update and remove notes from a volunteer record.
Volunteers Manage Files Add
Allows a user to add file attachments to a volunteer record.
Volunteers Manage Files Update
Allows a user to remove file attachments from a volunteer record.
Volunteers Manage Appointments Add
Allows a user to add appointments from a given volunteer record.
Volunteers Manage View Health
Introduced in version 1.5.3.
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.
Volunteers Monitoring
Introduced in version 1.5.0.
Allows users access to the ‘Monitoring’ tab within a given volunteer record.
Volunteers Monitoring Manage
Introduced in version 1.5.0.
Allows users to access and manage certain volunteer device monitoring sources, settings, and audits.
Volunteers Saved Search Manage
Introduced in version 1.5.3.
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.
Volunteers eConsent
Introduced in version 1.5.0.
Allows access to the eConsent management area, to review and approve study specific eConsent requests.
Volunteers Correspondence
Activates component menu item, and allows users to review and acknowledge volunteers messages.
Volunteers Inbound
Activates component menu item, and allows users to review and manage inbound volunteer requests.
Volunteers Configure
Activates component menu item, and allows users the ability to manage a wide set of volunteer configurations.
Volunteers Recruit - Add
Introduced in version 1.5.3.
With this role action, users will have access to the ‘+Recruit’ action menu option available in the Volunteers > Manage search results page. Additionally, within a given volunteer record, this role action will allow users to the ‘+Add’ action menu item within the Studies > Recruitment area.
Volunteers Manage Privacy Remove
Introduced in ClinSpark 22.3.
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.
Devices Manage
Activates component menu item, and allows users to review and manage site devices.
Devices Configure
Activates component menu item, and allows users to manage device categories and basic integrated EDC device details.
Administration Studies
Activates component menu item for Administration > Studies in addition to Study > Configure.
This allows user to browse study configuration details and various audits related to the configurations.
Component menu…
And study configuration details…
Additionally, modifying of an existing Recruitment Questionnaire is currently also possible with the “Administration Studies” action role. This will be resolved in a future release to be a separate role action.
Administration Studies Manage
Allows a user to manage various study specific configurations within the Study > Configure component. This includes:
Adding and modifying study epochs and cohorts
Adding and modifying study sites
Managing cohort details and assignments
Adding and modifying study site and recruitment configurations
Modifying Medidata Rave and OpenClinica account details
Adding and modifying study Data Reviewers
Adding and modifying Informed Consent (ICF) configurations
Modifying Recruitment Questionnaire configurations
Modifying Sample Processing container settings
Modifying Subject Numbering configurations
The following screenshots provide some examples of the above configurations.
Study and study site:
Epochs:
Cohorts:
Informed Consent (ICF) configurations:
Administration Users
Activates Administration > Users component menu item and allows a read-only view of ClinSpark user account details, including audits.
Administration Users Manage
Introduced in version 1.5.3.
Allows users to fully manage ClinSpark user accounts. Users must also have the ‘Administration Users’ role action. Supported actions includes the following:
Export user list
Add new users
Modify existing users
Add/remove study restrictions
Add/remove site restrictions
Add/remove roles
Modify user image
Print user barcode
View user account audits
Note: ClinSpark ‘Superadmin’ accounts can only be managed by Foundry Health.
Administration Roles
Activates component menu item, and allows for the management of system roles with role action assignments.
Administration Sites
Activates component menu item, and allows users the ability to manage site configurations.
Administration Medical Dictionaries
Activates component menu item, and allows users to upload and manage system medical dictionaries.
Administration General Settings
Activates component menu item and allows users to manage a wide set of general system configurations.
Administration System Settings
Activates component menu item, and allows users basic management of system settings such as dashboard components and reports. This role action is typically provided and used by a small subset of ClinSpark users, usually system administrators.
NOTE: Administrative users with access to this area of ClinSpark are able to modify certain Report settings, such as report ‘Name’. Users should avoid changing report names unless otherwise directed by Foundry Health. Report naming conventions are followed in ClinSpark to ensure superadmin users are able to review the synchronization state of deployed report settings when ClinSpark upgrades occur. Details about that process are noted in this article.
If there are questions or needs around the naming of reports, Administrative users are encouraged to reach out to Foundry Health via the service desk.
Administration Utilities
Activates component menu item, and allows users to perform study design import/export.
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.
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.
Correspondence Call
Allows a user to perform calls to volunteers. This role action impacts call functionality present within volunteer profiles and on calendar components.
Correspondence SMS
Where supported, this role action allows a user to send SMS messages to volunteers. Currently this is within the Study Subject, Volunteer, Recruit, and Calendar components.
Correspondence SMS Batch
Where supported, this role action allows a user to send SMS correspondence in batch. Currently this is within the Study Subject and Recruit components.
Correspondence Email
Where supported, this role action allows a user to send email messages to volunteers. Currently this is within the Study Subject, Volunteer, Recruit, and Calendar components.
Correspondence Email Batch
Where supported, this role action allows a user to send email correspondence in batch. Currently this is within the Study Subject and Recruit components.
Correspondence - Template Bypass
Where supported, this allows a user to send correspondence beyond what is provided by pre-defined system templates.
VCT Support
Allows for use of over-volunteering functionality that redirects to Verified Clinical Trials.
Result File Access
Allows user to download lab result files.
Mock Results Generation
Allows user generate mock lab result files while the system is running in ‘test mode’.
Pharmacy
Introduced in version 22.2.
Users with this role action will be able access the Study > Pharmacy component and associated features therein.
