Descriptions of permissions in Oracle Clinical One Platform

A Descriptions of permissions in Oracle Clinical One Platform

Browse descriptions and additional information for every study role permission available in the application.

Note:

An Oracle employee who has an Oracle Single Sign-On (SSO) account cannot sign data, even if they are assigned the appropriate permissions in the application (Approve and Sign Assigned Data Only and Approve and sign subject data). For more information on these two permissions, scroll down to the Clinical Data Collection section.

For global user roles descriptions see Roles for global users in Oracle Clinical One Platform and Oracle Clinical One Digital Gateway.

Sponsor and site permissions

On the Create Study Role dialog, when you select the Sponsor type of study role, you see the following permissions to select for your study role.

Table A-1 Administrative

Permission	Description	Notes
Run the Study Roles Report	Allows a user to generate the Study Roles report, in the Draft (Study Design) mode for a specific study.	This is a permission only for study-level users. If a user wants to run the report at a global level, they need a global role assigned to them to run the Study Roles Report By Study.
View Only for Unblinded Support Users	Allows a user to view the study data. Typically assigned to Oracle Support users.	Does not require any other permission to have access to this report. Caution: Can unblind users. Use with caution.

Permission

Description

Notes

Run the Study Roles Report

Allows a user to generate the Study Roles report, in the Draft (Study Design) mode for a specific study.

This is a permission only for study-level users.

If a user wants to run the report at a global level, they need a global role assigned to them to run the Study Roles Report By Study.

View Only for Unblinded Support Users

Allows a user to view the study data.

Typically assigned to Oracle Support users.

Does not require any other permission to have access to this report.

Caution:

Can unblind users. Use with caution.

Table A-2 CRF Submit Access

Permission	Description	Notes
Confirm download of Archival PDFs and content (Site)	Allows a user to confirm that they downloaded an Archival PDF, Custom PDF, or Kit Chain of Custody (Blinded) report generated and shared by a sponsor user. Allows a site user to generate the Site Confirmation report. Must be assigned along with the Download Archival PDFs and Audit Report permission.	This is a permission for site users, but can also be assigned to a sponsor user. Caution: Assigning site permissions, in addition to sponsor permissions to a sponsor study role, can result in permission conflicts that could impact a user’s ability to perform certain tasks.
Download Archival PDFs and Audit Reports (Site)	Allows a user to download an Archival PDF and audit reports. Must be assigned along with the Confirm download of Archival PDFs and content permission.	This is a permission for site users, but can also be assigned to a sponsor user.
Run Archival PDFs for your site(s) (Site)	Allows a user to generate the Archival PDF and audit reports for their site.	This is a permission for site users, but can also be assigned to a sponsor user. Does not require any other permission to have access to this report.
Run and download Site Confirmation and Download Log audit reports	Allows a user to generate and download the Site Confirmation and Download Log reports.	This is a permission for sponsor users. Does not require any other permission to have access to these reports.
Run and download all PDF request types and Audit reports. Enable Share with Sites, and Site Confirmation	Allows a user to generate and download all PDF Archives request types and audit reports. When assigned, this enables the settings, Share with Sites, and Confirm Site Downloads for Archival and Custom requests.	This is a permission for sponsor users.

Table A-3 Clinical Data Collection

Permission	Description	Notes
Add a Lab to a Site	Allows a user to associate a lab with a site.	This is a permission for site users, but can also be assigned to a sponsor user. Must be assigned along with the View Sites permission.
Add and Update Lab Normal Ranges	Allows a user to create and update lab normal ranges for each lab.	This is a permission for both sponsor and site users. Must be assigned along with the View Sites permission.
Answer Queries	Allows a user to answer queries in a form.	This is a permission for site users, but can also be assigned to a sponsor user. Must be assigned along with the following permissions: View Form Data for Subjects View Queries View All Queries (optional) View Sites
Approve and Sign Assigned Data Only	Allows a user to only sign data that has been assigned to their role at the form or visit level.	This is a permission for both sponsor and site users. Must be assigned along the following permissions: View Form Data for Subjects View Sites
Approve and sign subject data	Allows a user to sign a subject's data in the application at the casebook, form, and visit level.	This is a permission for site users, but can also be assigned to a sponsor user. Must be assigned along the following permissions: Edit Form Data for Subjects View Form Data for Subjects View Sites
Create and Add Labs to a Site	Allows a user to create and associate a lab to a site.	This is a permission for both sponsor and site users. Must be assigned along with the View Sites permission.
Dispense Kits with Calculated Doses	Allows a user to dispense kits with calculated doses.	This is a permission for site users, but can also be assigned to a sponsor user. Must be assigned along with the following permissions: View Sites View Form Data for Subjects View Blinded Dispensation Details with Calculated Doses
Dispense Kits without Calculated Doses	Allows a user to dispense kits without calculated doses, such as kits containing the investigational product or kits required for titration.	This is a permission for site users, but can also be assigned to a sponsor user. Must be assigned along with the following permissions: View Sites View Form Data for Subjects View Blinded Dispensation Details with Calculated Doses
Edit Classified Subject Data Only	Allows a user to edit classified subject data only, in a form. Note: When a data manager is assigned this permission, they may notice that they have the ability to edit forms that don't contain classified data. Advise data managers to only work with the forms that contain classified data.	This is a permission for both sponsor and site users. Must be assigned along with the following permissions: View Sites View Form Data for Subjects View Classified Subject Data Only
Edit Form Data for Subjects	Allows a user to perform the following: Complete and edit forms for a subject. Clear the Visit Date and data on forms. Undo subjects if added in error, when no data collection has occurred. Enables the Screen and Randomize buttons. Note: If users need to screen subjects and enter data but not randomize them, see What should I do when users need to screen data?	This is a permission for site users, but can also be assigned to a sponsor user. Must be assigned along with the following permissions: View Sites View Form Data for Subjects
Edit Visit Dates	Allows a user to fill-in or update the Visit Date field in a form.	This is a permission for site users, but can also be assigned to a sponsor user. Must be assigned along with the following permissions: View Sites View Form Data for Subjects
Integrate Subject Data	Allows a user to integrate subject data across applications, through integrations.	Typically, this is a permission assigned to an integration user who is part of your study. The user account that is assigned this permission doesn't usually sign into the application. They simply need this permission in the application, so they can operate with the integration data.
Randomize Subjects	Allows a user to start a randomization visit, complete associated forms, and randomize a subject.	This is a permission for site users, but can also be assigned to a sponsor user. Must be assigned along with the following permissions: View Sites View Form Data for Subjects
Skip Visits	Allows a user to skip visits in a subject's schedule.	This is a permission for site users, but can also be assigned to a sponsor user. Must be assigned along with the following permissions: View Sites View Form Data for Subjects
Take Action on Connected Devices	Allows a user to refresh, activate, and dispense medical devices to a subject.	This is a permission for site users, but can also be assigned to a sponsor user. Must be assigned along with the following permissions: View Sites View Form Data for Subjects
Unblind the Treatment Arm for a Subject or Code Break	Allows a user to perform a code break on a subject during the study conduct period.	This is a permission for site users, but can also be assigned to a sponsor user. Caution: Can unblind users. Use with caution. Must be assigned along with the following permissions: View Sites View Form Data for Subjects
Update Subject Number after Creation	Allows a user to update a subject number during the study conduct period.	This is a permission for both sponsor and site users.
View Blinded Dispensation Details with Calculated Doses	Allows a user to view blinded dispensation details when a kit with calculated doses is dispensed to a subject.	This is a permission for site users, but can also be assigned to a sponsor user. This permission can be assigned in conjunction with other permissions related to dispensation or randomization, so the appropriate blinded site users can view dispensation details.
View Blinded Dispensation Details without Calculated Doses	Allows a user to view blinded dispensation details when a kit without calculated doses is dispensed to a subject. For example, a blinded site user can view dispensation details when a kit with the investigational product or titration is dispensed.	This is a permission for site users, but can also be assigned to a sponsor user. This permission can be assigned in conjunction with other permissions related to dispensation or randomization, so the appropriate blinded site users can view dispensation details.
View Classified Subject Data Only	Allows a user to view only classified data in a form.	This is a permission for both sponsor and site users. This permission must always be assigned along with the Edit Classified Subject Data Only permission.
View Form Data for Subjects	Allows a user to view data in forms for subjects.	This is a permission for both sponsor and site users. This permission must be assigned in conjunction with other permissions related to data collection, so the site user can view and complete forms.
View Queries	Allows a user to view queries raised against answer fields in forms.	This is a permission for site users, but can also be assigned to a sponsor user. This permission must be assigned in conjunction with other permissions related to query management, so a user can view, answer, create, or close queries.

Table A-4 Data Extract

Permission	Description	Notes
Execute ODM Administrative Data API	Allows a user to use specific API endpoints to extract administrative data in an ODM-XML format.	This permission is available for sponsor users only.
Execute ODM Clinical Data API with Hidden Data	Allows a user to use specific API endpoints to extract clinical data and hidden study data in an ODM-XML format.	This permission is available for sponsor users only. Caution: Can unblind users. Use with caution.
Execute ODM Clinical Data API without Hidden Data	Allows a user to use specific API endpoints to extract clinical data without any hidden study data in an ODM-XML format.	This permission is available for sponsor users only.
Execute ODM Metadata API	Allows a user to use specific API endpoints to extract API Metadata in an ODM-XML format.	This permission is available for sponsor users only.
Run the Subject Data Extract	Allows a user to extract study data in a CSV, XPORT, and CPORT format by running the Subject Data Extract.	This permission is available for sponsor users only. Caution: Can unblind users. Use with caution.

Table A-5 Inventory Management

Permission	Description	Notes
Blinded Depot User	Allows a user to see the blinded supply inventory: Depot Inventory tab; Kit numbers for all blinded, unblinded, and unblinded pharmacist kit types;	Caution: Use with caution. The Blinded Depot User permission grants access to view the Sequence Number, which could potentially unblind the study for blinded site users and blinded sponsor users. This permission is for both sponsor and site users. Note: This permission only lets a user view supplies from depots or sites that they're assigned to. They cannot see the full description of kits for blinded and unblinded pharmacist kits. This permission can be found in the following predefined study role templates: Blinded Depot User (template) Clinical Supply Manager (template)
Create Manual Shipments	Allows a user to create manual shipments to be delivered to sites.	This permission is for both sponsor and site users. Note: Site users cannot create manual shipments but can request a shipment to be created. In addition, blinded sponsor users are not able to create manual shipments. Must be assigned along with the following permissions: View Sites View Site Inventory View Shipments to Sites This permission can be found in the following predefined study role templates: Site User (template) Clinical Supply Manager (template) CRA (template) Study Manager (template) Unblinded Depot User (template) Pharmacy User (template)
Create Shipments to Depots	Allows a user to create a supplying or a destruction shipment to be sent to another depot.	This permission is available for sponsor users only. Caution: Can unblind users. Use with caution.
Perform Supplies Reconciliation at Site	Allows a user to perform kit reconciliation at a site.	This permission is for both sponsor and site users. Must be assigned along with the following permissions: View Sites View Site Inventory
Receive New Shipments at the Depot	Allows a user to register shipments and add them to a depot's inventory.	This permission is available for sponsor users only. Caution: Can unblind users. Use with caution.
Receive Shipments and Update Site Inventory	Allows a user to receive shipments at a site and update the site inventory.	This permission is for site users, but can also be assigned to sponsor users. Must be assigned along with the following permissions: View Sites View Site Inventory View Shipments to Sites
Receive and Reconcile Shipments at the Depot	Allows a user to receive shipments sent by a depot and reconciling shipments at a depot level.	This permission is available for sponsor users only. Caution: Can unblind users. Use with caution. Must be assigned along with the following permissions: View Depots View Sites
Release Shipments from Quarantine	Allows a user to release all kits in a shipment from Quarantine and update their status to Available.	This permission is for sponsor users, typically Clinical Supply Managers. Caution: Can unblind users. Use with caution.
Update Supplies after Design Approval	Allows a user to update study supply attributes after a study version has been approved. This is typically done to correct mistakes made during kit creation. WARNING: A user with this permission can modify kits in ways that can be detrimental to approved study versions. The permission should be removed after the updates are made.	This permission is available for sponsor users only. Caution: Can unblind users. Use with caution. Must be assigned along with the following permission to update kits. Design Supplies and Dispensation
Update the Shipment Order Form	Allows a user to restrict a sites' ability to resend depot order forms after orders have been fulfilled.	This permission is for sponsor users, typically Clinical Supply Managers. Must be assigned along with the Receive and Reconcile Shipments at the Depot permission.
View Shipments to Sites	Allows a user to view shipments sent to sites.	This permission is for both sponsor and site users. Must be assigned along with the View Site Inventory permission.
View Site Inventory	Allows a user to view a site's inventory.	This permission is for both sponsor and site users.
View Unblinded Pharmacist Kits	Allows a user to view unblinded pharmacist kits in both inventories: site and study inventory.	This permission is for both sponsor and site users. Caution: Can unblind users. Use with caution. Must be assigned along with the following permissions: View Sites View Depots View Site Inventory Manage Study Inventory for Unblinded Users

Table A-6 Notifications

Permission	Description	Notes
Receive Notification of Depot Shipments	Allows a user to receive a notification whenever a depot shipment is created or updated.	This permission is available for sponsor users only. Caution: Can unblind users. Use with caution.
Receive Notification of Shipments	Allows a user to receive a notification whenever: A new shipment request is created; A new shipment for destruction was created; A kit is missing for a shipment sent for destruction A shipment for destruction is not received by a depot A shipment cannot be created A shipment is cancelled	This permission is for both sponsor and site users.
Receive Rule Failure Notification for Locked Data	Allows a user to receive a notification when a rule is unable to update a target because it is locked.	This permission is available for sponsor users only.
Receive Site has been Updated Notification	Allows a user to receive a notification when a site changes status, such as from going from New to Active.	This permission is for both sponsor and site users.
Receive the Code Break Notification	Allows a user to receive a notification when a subject is unblinded due to a code break.	This permission is for both sponsor and site users.
Receive the Dispensation Notification	Allows a user to receive the Subject Dispensation notification, whether the dispensation succeeded or failed.	This permission is for both sponsor and site users.
Receive the Dispensation with Dosing Instructions Notification	Allows a user to receive the Subject Dispensation notification with dosing instructions for kits with calculated doses, whether the dispensation succeeded or failed.	This permission is for both sponsor and site users.
Receive the Pending Signatures Notification	Allows a user to receive a notification informing them when a signature, for a site they are assigned to, has a defined target date that has become overdue.	This permission is for both sponsor and site users.
Receive the Quarantined Depot Shipment Notification	Allows a user to receive a notification whenever a depot shipment or kits are quarantined.	This permission is available for sponsor users only.
Receive the Quarantined Site Shipment Notification	Allows a user to receive a notification whenever a site shipment or kits are quarantined.	This permission is for both sponsor and site users.
Receive the Randomization Notification	Allows a user to receive a notification when a subject is either successfully randomized or their randomization failed at a site they are assigned to.	This permission is for both sponsor and site users.
Receive the Released from Quarantine Notification (Depot)	Allows a user to receive a notification whenever a depot shipment or kits are released from quarantine.	This permission is available for sponsor users only.
Receive the Released from Quarantine Notification (Site)	Allows a user to receive a notification whenever a site shipment or kits are released from quarantine.	This permission is for both sponsor and site users.
Receive the Study Limits Notification	Allows a user to receive a notification when the randomization limit is reached for a study, site, country, or cohort; or a percentage of the randomization limit is reached for a study, site, country, or cohort.	This permission is for both sponsor and site users.
Receive the Subject Completion Notification	Allows a user to receive a notification when a subject at a site they are assigned to completes a study.	This permission is for both sponsor and site users.
Receive the Subject Number Update Notification	Allows a user to receive a notification when a subject's number is updated in a system.	This permission is for both sponsor and site users.
Receive the Subject Rollover Notification	Allows a user to receive a notification when a subject at a site they are assigned to is enrolled into a rollover study.	This permission is for both sponsor and site users.
Receive the Subject Screening Notification	Allows a user to receive a notification when a subject is either successfully screened or their screening failed at a site they are assigned to.	This permission is for both sponsor and site users.
Receive the Subject Transferred Notification	Allows a user to receive a notification when a subject transfers to another site.	This permission is for both sponsor and site users.
Receive the Subject Visit Notification	Allows a user to receive a notification when a subject completes a non-dispensation or optional visit at a site they are assigned to. The notification is sent both when the subject successfully completes the visit and when one or more questions have errors.	This permission is for both sponsor and site users.
Receive the Subject Withdrawal Notification	Allows a user to receive a notification when a subject withdraws from a study.	This permission is for both sponsor and site users.
Receive the Unblinded Dispensation Notification	Allows a user to receive a notification when an unblinded dispensation event is successfully completed or when the unblinded dispensation failed at a site they are assigned to.	This permission is for both sponsor and site users. Caution: Can unblind users. Use with caution.
Receive the Unblinded Dose Hold Notification	Allows a user to receive a notification when an unblinded dose hold event is successfully completed at a site they are assigned to.	This permission is for both sponsor and site users. Caution: Can unblind users. Use with caution.
Receive the Unblinded Kit Misallocation Notification	Allows a user to receive a notification when a kit status is manually updated to Missallocated when dispensed in error. For example, someone at the site might have dispensed a subject with kit different from the one indicated by Oracle Clinical One Platform; or a site user might have entered data in the wrong subject's visit and dispensed a kit that was not supposed to be dispensed.	This permission is for both sponsor and site users. Caution: Can unblind users. Use with caution.
Receive the Unblinded Pharmacist Dispensation Notification	Allows a user to receive a notification when an unblinded pharmacist kit is successfully dispensed or not by an unblinded site user.	This permission is for both sponsor and site users. Caution: Can unblind users. Use with caution.
Receive the Unblinded Randomization Notification	Allows a user to receive a notification when a subject is either successfully randomized with unblinded kits or their unblinded randomization failed at a site they are assigned to.	This permission is for both sponsor and site users. Caution: Can unblind users. Use with caution.
Receive the Unscheduled Visit Notification	Allows a user to receive a notification when a subject completes an unscheduled visit at a site they are assigned to. The notification is sent both when the subject successfully completes the visit and when one or more questions have errors.	This permission is for both sponsor and site users.

Table A-7 Reports

Permission	Description	Notes
Lab Normal Report Post	Allows a user to run the Lab Normal Range report.	This permission is for both sponsor and site users.Users must have the following permission or role to run the report: Add and Update Lab Normal Ranges permission View Only Unblinded Support template role
Run the Blinded Chain of Custody Report	Allows a user to run the Kit Chain of Custody (blinded) report.	This permission is for both sponsor and site users. Caution: Can unblind users. Use with caution.
Run the Blinded Inventory Report	Allows a user to run the Kit Inventory (Blinded) report.	This permission is for both sponsor and site users.
Run the Blinded Kits Dataset	Allows a user to operate the Blinded Kits Dataset in Oracle Clinical One Analytics	This permission is for both sponsor and site users.
Run the Blinded Randomization Report	Allows a user to run the Blinded Randomization Report.	This permission is for sponsor users and CRAs.
Run the Blinded Subject Events Dataset	Allows a user to operate the Blinded Subject Events Dataset in Oracle Clinical One Analytics	This permission is for both sponsor and site users.
Run the Enrollment Report	Allows a user to run the Study Enrollment report.	This permission is for both sponsor and site users.
Run the Kit Dispensation Report	Allows a user to run the Kit Dispensation report.	This permission is for both sponsor and site users.
Run the Kit Reconciliation Report	Allows a user to run the Kit Reconciliation report.	This permission is for both sponsor and site users.
Run the Order Summary Report	Allows a user to run the Shipment Order Summary report.	This permission is for both sponsor and site users.
Run the Site and Depot Report	Allows a user to run the Audit Report Site and Depot report.	This permission is for both sponsor and site users.
Run the Study Codelist Dataset	Allows a user to operate the Study Codelist dataset in Oracle Clinical One Analytics.	This permission is for both sponsor and site users.
Run the Study Design Report	Allows a user to run the Study Design report.	This permission is available for sponsor users only.
Run the Study Kits Dataset	Allows a user to operate the Study Kits dataset in Oracle Clinical One Analytics (which is planned for a future release).	Planned for future release. This permission is for both sponsor and site users.
Run the Study Query Dataset	Allows a user to operate the Study Query dataset in Oracle Clinical One Analytics.	This permission is for both sponsor and site users.
Run the Study Rules Report	Allows a user to run the Rules report.	This permission is available for sponsor users only.
Run the Subject Data Report	Allows a user to run the Subject Data report.	This permission is for both sponsor and site users.
Run the Subject Data for CTMS Report	Allows a user to run the Subject Data for CTMS report.	This permission is available for sponsor users only.
Run the Subject Dataset	Allows a user to operate the Subject dataset in Oracle Clinical One Analytics	This permission is for both sponsor and site users.
Run the Subject Events Report	Allows a user to run the Subject Events report.	This permission is for both sponsor and site users.
Run the Subject Form Items Dataset	Allows a user to operate the Subject Form Items dataset in Oracle Clinical One Analytics	This permission is for both sponsor and site users.
Run the Subject Forms Dataset	Allows a user to operate the Subject Forms dataset in Oracle Clinical One Analytics	This permission is for both sponsor and site users.
Run the Subject Query Report	Allows a user to run the Subject Queries report.	This permission is for both sponsor and site users.
Run the Subject Randomization Data Extract Report	Allows a user to generate the Subject Randomization Data Extract.	This permission is for sponsor users. To view the unblinding fields (Treatment Arm and Block ID) it must be assigned along with at least one of the following permissions: Receive the Unblinded Dose Hold Notification Upload and Generate Inventory Lists View Dispensation Exceptions Create and Manage Dispensation Exceptions Edit Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies Manage Study Inventory for Unblinded Users Manage Randomization Lists Create and Manage Lots Create Shipments to Depots Upload and Generate Randomization Lists Receive the Unblinded Kit Misallocation Notification View Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies Run the Unblinded Randomization Report
Run the Subject Visit Report	Allows a user to run the Subject Visits report (Blinded).	This permission is for both sponsor and site users.
Run the Titration Summary Report	Allows a user to run the Titration Summary report (Blinded).	This permission is for both sponsor and site users.
Run the Training Report	Allows a user to run the Clinical One Training report.	This permission is for both sponsor and site users.
Run the Unblinded Chain of Custody Report	Allows a user to run the Kit Chain of Custody (Unblinded) report.	This permission is available for sponsor users only. Caution: Can unblind users. Use with caution.
Run the Unblinded Inventory Report	Allows a user to run the Kit Inventory (Unblinded) report.	This permission is available for sponsor users only. Caution: Can unblind users. Use with caution.
Run the Unblinded Kits Dataset	Allows a user to run the Unblinded Kits Dataset.	This permission is for both sponsor and site users. Caution: Can unblind users. Use with caution.
Run the Unblinded Randomization Report	Allows a user to run the Randomization List report (Unblinded).	This permission is available for sponsor users only. Caution: Can unblind users. Use with caution.
Run the Unblinded Subject Events Dataset	Allows a user to operate the Unblinded Subject Events dataset in Oracle Clinical One Analytics	This permission is for both sponsor and site users. Caution: Can unblind users. Use with caution.
Run the Unblinded Subject Visit Schedule Report	Allows a user to run the Subject Visits (Unblinded) report.	This permission is available for sponsor users only. Caution: Can unblind users. Use with caution.
Run the Unblinded Titration Summary Report	Allows a user to run the Titration Summary (Unblinded) report.	This permission is available for sponsor users only. Caution: Can unblind users. Use with caution.
Run the User Assignment Report	Allows a user to run the User Assignment and User Assignment by Site reports.	This permission is for both sponsor and site users.
Run the User Upload Error Report	Allows a user to run the User Upload Error report.	This permission is available for sponsor users only.
Schedule Reports to Run	Allows a user to access the Schedule Reports side panel to create automated schedules for specific reports.	This permission is available for sponsor users only.
Study Design Report Suppress Randomization	Hides the Generated Randomization List details from the Study Design report from the user who has the permission assigned.	This permission is available for sponsor users only. Caution: Can unblind users. Use with caution.

Table A-8 Rules Management

Permission	Description	Notes
Design Custom Rules	Allows a rule designer to design custom JavaScript rules. Gives access to the Rule Management page.	This permission is for sponsor users only. Must be assigned along with the following permissions: View Sites View Form Data for Subjects Edit Form Data for Subjects
Publish Custom Rules	Allows a rule publisher to publish custom rules. Gives access to the Rule Management page.	This permission is for sponsor users only. Must be assigned along with the following permissions: View Sites View Form Data for Subjects Edit Form Data for Subjects
Re-run Rules	Allows a sponsor user to re-run a rule that was modified during the study conduct period. Gives access to the Rule Management page.	This permission is for sponsor users only. Must be assigned along with the following permissions: View Sites View Form Data for Subjects Edit Form Data for Subjects
Test Custom Rules	Allows a rule tester to test custom rules built by a rule designer. Gives access to the Rule Management page.	This permission is for sponsor users only. Must be assigned along with the following permissions: View Sites View Form Data for Subjects Edit Form Data for Subjects

Table A-9 Settings

Permission	Description	Notes
Configure Connected Device Study Settings	Allows a user to configure the settings and connection between Oracle Clinical One Platformand Oracle Health Sciences mHealth Connector Cloud Service to enable study designers and site users to create and dispense medical devices to subjects.	This permission is for sponsor users only. Must be assigned along with the View Study Settings permission.
Edit Welcome Details in General Study Settings	Allows a user to customize the welcome letter that study team members receive upon being provisioned in a study in Oracle Clinical One Platform. This permission gives a user the ability to edit the Welcome Letter field for an individual study.	This permission is for Sponsor users only. To customize the welcome letter at a global level, for all studies in an organization, the user must be assigned the Study Creator global role.
Manage Signature Settings	Allows a user to create and manage a Signature Configuration.	This is a permission for sponsor users only. Must be assigned along with the following permissions: View Form Data for Subjects View Study Settings

Permission

Description

Notes

Configure Connected Device Study Settings

Allows a user to configure the settings and connection between Oracle Clinical One Platformand Oracle Health Sciences mHealth Connector Cloud Service to enable study designers and site users to create and dispense medical devices to subjects.

This permission is for sponsor users only.

Must be assigned along with the View Study Settings permission.

Edit Welcome Details in General Study Settings

Allows a user to customize the welcome letter that study team members receive upon being provisioned in a study in Oracle Clinical One Platform. This permission gives a user the ability to edit the Welcome Letter field for an individual study.

This permission is for Sponsor users only.

To customize the welcome letter at a global level, for all studies in an organization, the user must be assigned the Study Creator global role.

Manage Signature Settings

Allows a user to create and manage a Signature Configuration.

This is a permission for sponsor users only.

Must be assigned along with the following permissions:

View Form Data for Subjects
View Study Settings

Table A-10 Study Management

Permission	Description	Notes
Answer Assigned Queries	Allows a user to answer queries that are assigned to a specific user role.	This permission is for both sponsor and site users. Must be assigned along with the following permissions: View Sites View Form Data for Subjects View All Queries
Close Queries	Allows a user to close queries in a study.	This permission is for sponsor users only. Must be assigned along with the following permissions: View Sites View Form Data for Subjects View Queries View All Queries
Create Candidate Queries	Allows a user to create candidate queries against answer fields.	This permission is for sponsor users only and is required only for users who do not already have the Create Queries permission. Must be assigned along with the following permissions: View Sites View Form Data for Subjects View Queries View All Queries
Create Queries	Allows a user to create all types of manual queries, such as standard queries, candidate queries, and assigned queries. A standard query appears for any user who has either one of these permissions: View Queries View All Queries If a user needs to view or answer an assigned query, they must be assigned the Answer Assigned Queries permission.	This permission is for sponsor users only. The Create Queries permission must be assigned along with these other permissions: View Sites View Form Data for Subjects
Create Shipments to DDF	Allows a user to create a shipment that must be sent to a drug-destruction facility.	This permission is for both sponsor and site users. Must be assigned along with the following permissions: View Depots View Shipments to Sites Manage Study Inventory for Unblinded Users
Delete Candidate Queries	Allows a user to delete candidate queries created by a sponsor user.	This permission is for sponsor users only. Must be assigned along with the following permissions: View All Queries View Queries View Sites View Form Data for Subjects
Freeze subject data entered at a site	Allows a user to freeze data in forms. Frozen data can not be modified.	This is a permission for sponsor users only, such as a data manager or CRA. Must be assigned along with the following permissions: View Sites View Form Data for Subjects
Lock Subject Data at a Site	Allows a user to lock and unlock data at the visit, form, and question level. If they have the View Form Data for Subjects permission, they are able to see if the visit, form, or question is locked.	This permission is for sponsor users only.
Reconcile Inventory	Allows a user to perform kit reconciliation in the study inventory.	This permission is for sponsor users only. Must be assigned along with the following permissions: View Sites View Form Data for Subjects View Queries
Transfer subjects between sites	Allows a user to transfer a subject from one site to another.	This permission is for sponsor users only. Must be assigned along with the following permissions: View Sites View Form Data for Subjects
Unfreeze subject data entered at a site	Allows a user to unfreeze data in forms.	This is a permission for sponsor users only, such as a data manager or CRA. Must be assigned along with the following permissions: View Sites View Form Data for Subjects
Undo Add Subject	Allows a user to undo (cancel) the addition of a subject added in error if no data collection has occurred.	This is a permission for site users.
Verify subject data entered at a site	Allows a user to verify data in forms.	This permission is for sponsor users only. Must be assigned along with the following permissions: View Sites View Form Data for Subjects
View All Queries	Allows a user to view all queries in a study, including queries assigned to a specific user role.	This permission is for sponsor users only. Must be assigned along with the permissions: View Sites View Form Data for Subjects

Table A-11 Study Setup

Permission	Description	Notes
Assign a Resupply Strategy to a Depot	Allows a user to assign a min/max resupply strategy to a depot.	This permission is for sponsor users only.
Assign a Resupply Strategy to a Site	Allows a user to assign a resupply strategy to a site.	This permission is for sponsor users only. Must be assigned along with the following permissions: View Sites Create and Manage Sites
Assign a SDV Strategy to a Site	Allows a user to assign an SDV strategy to a site.	This permission is for sponsor users only. Must be assigned along with the following permissions: View Sites Create and Manage Sites Create and Manage SDV Strategies
Assign a Study Version to a Site	Allows a user to assign a study version to a site.	This permission is for sponsor users only. Must be assigned along with the following permissions: View Sites Create and Manage Sites
Create and Manage Depots	Allows a user to create and manage depots.	This permission is for sponsor users only. Must be assigned along with the following permissions: View Depots
Create and Manage Dispensation Exceptions	Allows a user to create and manage dispensation exceptions.	This permission is for sponsor users only. Must be assigned along with the following permissions: View Dispensation Exceptions
Create and Manage Lots	Allows a user to create and manage lots.	This permission is for sponsor users only. Caution: Can unblind users. Use with caution.
Create and Manage SDV Strategies	Allows a user to create and manage source data verification strategies.	This permission is for sponsor users only.
Create and Manage Sites	Allows a user to create and manage sites.	This permission is for sponsor users only. Must be assigned along with the View Sites permission.
Edit General Study Settings	Allows a user to edit study settings located on the General tab.	This permission is for sponsor users only.
Edit Regions	Allows a user to edit regions in a study.	This permission is for sponsor users only. Must be assigned along with the View Study Settings permission.
Edit Study Settings	Allows a user to edit study settings located on the Study Settings tab.	This permission is for sponsor users only. Must be assigned along with the View Study Settings permission.
Edit Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies	Allows a user to edit supply settings, blinded groups, label groups, and resupply strategies located on the Supply Settings tab.	This permission is for sponsor users only. Caution: Can unblind users. Use with caution. Must be assigned along with the View Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies permission.
Manage Archives Settings	Allows a user access to the Archives Settings tab to manage Oracle CRF Submit notifications.	For more information about Oracle CRF Submit notifications, see Email and in-application notifications.
Manage Subject Number Configuration	When this permission is added to a study role, the Study Setting, Replace Subject Number with Randomization Number appears under the Study Settings section on the Study Settings tab for that study role.	For more information about this setting, see Specify study, enrollment, and visits settings.
Move a Study Design to Testing or Production	Allows a user to move a study version from Draft to Testing and from Testing to Production.	This permission is for sponsor users only.
Upload and Generate Inventory Lists	Allows a user to upload and generate kit lists.	This permission is for sponsor users only. Caution: Can unblind users. Use with caution. Must be assigned along with the View Study Design permission.
Upload and Generate Randomization Lists	Allows a user to upload and generate randomization lists.	This permission is for sponsor users only. Caution: Can unblind users. Use with caution. Must be assigned along with the View Study Design permission.
View Depots	Allows a user to view depots in a study.	This permission is for sponsor users only.
View Dispensation Exceptions	Allows a user to view dispensation exceptions that have been created.	This permission is for sponsor users only.
View Regions	Allows a user to view regions in a study.	This permission is for sponsor users only. Must be assigned along with the View Study Settings permission.
View Role Assignments for Study Users	Allows a user to view what roles and permissions are assigned to users in a study they are a part of.	This permission is for sponsor users only.
View Sites	Allows a user to view sites created in a study.	This permission is for sponsor users only.
View Study Design	Allows a user to view all study design elements in the Draft version of a study and lets them enter and manage comments in Study Design and Testing Mode. Specifically offers view only access to the Data Collection and Study Supplies tabs in Study Design and Testing mode.	This permission is for sponsor users only.
View Study Settings	Allows a user to view all fields and settings located on the Study Settings tab.	This permission is for sponsor users only.
View Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies	Allows a user to view all fields and settings located on the Supply Settings tab.	This permission is for sponsor users only. Caution: Can unblind users. Use with caution.

Table A-12 Trial Management

Permission	Description	Notes
Close Trial Management Events	Allows a user to close any events related to the management of their study.	Planned for a future release. This permission is available for sponsor users only.
Create Actions on Trial Management Event Records	Allows a user to create actions for every trial management event record in the system.	Planned for a future release. This permission is available for sponsor users only.
Create Trial Management Event Records	Allows a user to create records for every trial management event.	Planned for a future release. This permission is available for sponsor users only.
Create Trial Management Event Records from Subjects Tab	Allows a user to create a trial management event record on the Subjects page.	Planned for a future release. This is a permission for site users, but can also be assigned to a sponsor user.
Create Unblinded Trial Management Records	Allows a user to create unblinded trial management records in their study.	Planned for a future release. This permission is available for sponsor users only. Caution: Can unblind users. Use with caution.
Edit Actions on Trial Management Event Records	Allows a user to edit the associated actions of a trial management event record.	Planned for a future release. This permission is for both sponsor and site users.
Edit Trial Management Event Records	Allows a user to edit records for trial management events.	Planned for a future release. This permission is available for sponsor users only.
Edit Trial Management Event Records from Subjects Tab	Allows a user to edit records for trial management events on the Subjects page.	Planned for a future release. This is a permission for site users, but can also be assigned to a sponsor user.
Edit Unblinded Trial Management Records	Allows a user to edit unblinded record of trial management.	Planned for a future release. This permission is available for sponsor users only. Caution: Can unblind users. Use with caution.
Open Trial Management Events	Allows a user to open new trial management events.	Planned for a future release. This permission is available for sponsor users only.
View Actions on Trial Management Event Records	Allows a user to view records of trial management events.	Planned for a future release. This permission is for both sponsor and site users.
View Blinded Trial Management Records	Allows a user to view blinded records of trial management.	Planned for a future release. This permission is for both sponsor and site users.
View Trial Management Event Records	Allows a user to view all records of trial management events.	Planned for a future release. This permission is available for sponsor users only.
View Trial Management Event Records from Subjects Tab	Allows a user to view records of trial management events on the Subjects page.	Planned for a future release. This is a permission for site users, but can also be assigned to a sponsor user.
View Trial Management Event Records with Actions Assigned to me	Allows a user to view records of trial management events with actions assigned to them in the system.	Planned for a future release. This permission is for both sponsor and site users.
View Unblinded Trial Management Records	Allows a user to view unblinded record of trial management.	Planned for a future release. This permission is available for sponsor users only. Caution: Can unblind users. Use with caution.

Table A-13 Unblinded Study Management

Permission	Description	Notes
Manage Randomization Lists	Allows a user to update randomization lists.	This permission is for sponsor users only. Caution: Can unblind users. Use with caution. Must be assigned along with the following permissions: View Study Design Upload and Generate Randomization Lists
Manage Study Inventory for Unblinded Users	Allows a user to manage kits and shipments on the Study Inventory tab.	This permission is for sponsor users only. Caution: Can unblind users. Use with caution.
Reveal the Treatment Arm for a Subject or Code View	Allows a user to perform a code view for a subject.	This permission is for sponsor users only. Caution: Can unblind users. Use with caution.
Update Inventory Lists	Allows a user to update and delete kit lists. A user should only delete a kit list if it was created in error, and it should be done before dispensing activities begin. WARNING: Deleting an entire kit list can negatively impact dispensation activities, downstream reporting, and data extracts.	This permission is for sponsor users only. Caution: Can unblind users. Use with caution. Must be assigned along with the following permissions: View Study Design Upload and Generate Inventory Lists (is needed to delete a list).

Design permissions

Note:

The following permissions are for sponsor users with a design type role only. These permissions are not available for sponsor and site user type study roles.

Table A-14 Reports

Permission	Description	Notes
Run the Data Collection Design Dataset	Allows a user to run the Study Design Delta report and operate the Data Collection Design dataset in Oracle Clinical One Analytics	This permission is for design type role only.
Run the Kits and Randomization Design Dataset	Allows a user to operate the Kits and Randomization Design dataset in Oracle Clinical One Analytics	This permission is for design type role only.

Table A-15 Study Design

Permission	Description	Notes
Add and Administer Study Users	Allows a user to add and manage users created in a study.	This permission is for design type role only.
Create Study Roles	Allows a user to create custom study roles.	This permission is for design type role only.
Delete Custom Code Lists	Allows a user to remove code lists.	This permission is for design type role only.
Design Forms	Allows a user to design all elements of a form, whether it is a one-section form, a two section form, a lab form, and many more.	This permission is for design type role only.
Design Clinical Supplies Forms	Allows a user to design drug reconciliation forms.	This permission is for design type role only. Must be assigned along with the Design Supplies and Dispensationpermission.
Design Randomization	Allows a user to design all elements of a randomization.	This permission is for design type role only. Caution: Can unblind users. Use with caution.
Design SDV Properties on Forms	Allows a user to specify SDV properties for each question in a form.	This permission is for design type role only.
Design Supplies and Dispensation	Allows a user to design kit types, treatment arms, and drug reconciliation forms.	This permission is for design type role only. Caution: Can unblind users. Use with caution.
Design Visits and Events	Allows a user to design all available types of visits and events.	This permission is for design type role only.
Manage Study Code Lists	Allows a user to create and manage system and custom code lists for the study they are assigned to.	This permission is for design type role only.
Run the Draft Study Design Report	Allows a user to run the Study Design report in Draft.	This permission is for design type role only.
Run the Study Roles and User Assignment Report (Design Mode)	Allows a user to run the Study Roles and User Assignment reports in Draft.	This permission is for design type role only.
Upload Users in Bulk	Allows a user to download and import the User Upload Template and provides access the User Upload Error report.	This permission is for design type role only.
View Design	Allows a user to view a study's design in Draft.	This permission is for design type role only.