A Descriptions of permissions in Oracle Clinical One Platform

Browse descriptions and additional information for every permission displayed in the application.

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.

Category Permission Description Notes

Administrative

Run the Study Roles Report

Lets you generate the Study Roles report, at a study level.

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

Can be included in a Sponsor and Site type of study role.

Administrative

View Only for Unblinded Support Users

Lets you view the study data.

Typically assigned to Oracle Support users. Does not require any other permission to have access to this report.

Can unblind users. Use with caution.

CRF Submit Access

Confirm download of Archival PDFs and content

Lets you confirm that you have downloaded the Archival PDF put at your disposal by a site user.

Must be assigned along with the Download Archival PDFs and Audit Report permission.

This is a permission for site users.

CRF Submit Access

Download Archival PDFs and Audit Reports

Lets you download an Archival PDF and any other audit reports.

Must be assigned along with the Confirm download of Archival PDFs and content permission.

This is a permission for site users.

CRF Submit Access

Run Archival PDFs for your site(s)

Lets you run the Archival PDF for your site, so other site users may download it and confirm its download.

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

This is a permission for site users.

CRF Submit Access

Run and download Site Confirmation and Download Log audit reports

Lets you generate and download the two reports: Site Confirmation and Download Log.

Does not require any other permission to have access to these reports.

This is a permission for sponsor users.

CRF Submit Access

Run and download all PDF request types and Audit reports. Enable Share with Sites, and Site Confirmation

Lets you perform a series of tasks:
  • Run and download all types of PDF archives and audit reports.
  • Enable the Share with Sites and Site Confirmation options, so a site user can Rshare PDF archives with sites and site users can confirm that they have downloaded the archives.

This is a permission for sponsor users.

Clinical Data Collection

Add a Lab to a Site

Lets you associate a lab with a site.

Must be assigned along with the View Sites permission.

This is a permission for site users, but can also be assigned to a sponsor user.

Clinical Data Collection

Add and Update Lab Normal Ranges

Lets you create and update lab normal ranges for each lab.

Must be assigned along with the View Sites permission.

This is a permission for sponsor users, but can also be assigned to a site user.

Clinical Data Collection

Answer Queries

Lets you answer queries in a form.

Requires the following permissions:
  • View Form Data for Subjects
  • View Queries
  • View All Queries (optional)
  • View Sites

This is a permission for site users, but can also be assigned to a sponsor user.

Clinical Data Collection

Approve and sign subject data

Lets you sign a subject's data in the application.

Requires the following permissions:
  • Edit Form Data for Subjects
  • View Form Data for Subjects
  • View Sites

This is a permission for site users, but can also be assigned to a sponsor user.

Clinical Data Collection

Create and Add Labs to a Site

Lets you create and associate a lab to a site.

Must be assigned along with the View Sites permission.

This is a permission for site users, but can also be assigned to a sponsor users.

Clinical Data Collection

Dispense Kits with Calculated Doses

Lets you dispense kits with calculated doses.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects
  • View Blinded Dispensation Details with Calculated Doses

This is a permission for site users, but can also be assigned to a sponsor user.

Clinical Data Collection

Dispense Kits without Calculated Doses

Lets you dispense kits without calculated doses, such as kits containing the investigational product or kits required for titrations.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects
  • View Blinded Dispensation Details with Calculated Doses

This is a permission for site users, but can also be assigned to a sponsor user.

Clinical Data Collection

Edit Classified Subject Data Only

Lets you edit classified subject data only, in a form.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects
  • View Classified Subject Data Only
None.

Clinical Data Collection

Edit Form Data for Subjects

Lets you complete or edit forms for a subject.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects

This is a permission for site users, but can also be assigned to a sponsor user.

Clinical Data Collection

Edit Visit Dates

Lets you fill-in or update the Visit Date field in a form.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects

This is a permission for site users, but can also be assigned to a sponsor user.

Clinical Data Collection

Freeze subject data entered at a site

Lets you freeze data in forms.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects

This is a permission for sponsor users only, such as a data manager or CRA.

Clinical Data Collection

Integrate Subject Data

Lets you 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.

Clinical Data Collection

Lock Subject Data at a Site

If you have the View Form Data for Subjects permission, you are able to see if the visit, form, or question is locked.

This is a permission for sponsor users.

Clinical Data Collection

Randomize Subjects

Lets you complete start a randomization visit, complete associated forms, and randomize a subject.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects

This is a permission for site users, but can also be assigned to a sponsor user.

Clinical Data Collection

Skip Visits

Lets you skip visits in a subject's schedule.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects

This is a permission for site users, but can also be assigned to a sponsor user.

Clinical Data Collection

Take Action on Connected Devices

Lets you refresh, activate, and dispense medical devices to a subject.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects

This is a permission for site users, but can also be assigned to a sponsor user.

Clinical Data Collection

Unblind the Treatment Arm for a Subject or Code Break

Lets you perform a code break on a subject during the study conduct period.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects

Can unblind users. Use with caution.

Clinical Data Collection

Unfreeze subject data entered at a site

Lets you unfreeze data in forms.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects

This is a permission for sponsor users only, such as a data manager or CRA.

Clinical Data Collection Update a subject number after creation

Lets you update a subject number during the study conduct period.

This is a permission for site users, but can also be assigned to a sponsor user.

Clinical Data Collection

Verify subject data entered at a site

Lets you verify data in forms.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects

This is a permission for sponsor users only.

Clinical Data Collection

View Blinded Dispensation Details with Calculated Doses

Lets you view blinded dispensation details when a kit with calculated doses is dispensed to a subject.

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.

This is a permission for site users, but can also be assigned to a sponsor user.

Clinical Data Collection

View Blinded Dispensation Details without Calculated Doses

Lets you 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 titrations is dispensed.

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.

This is a permission for site users, but can also be assigned to a sponsor user.

Clinical Data Collection

View Classified Subject Data Only

Lets you view only classified data in a form.

This permission must always be assigned along with the Edit Classified Subject Data Only permission.

This is a permission for both sponsor and site users.

Clinical Data Collection

View Form Data for Subjects

Lets you view data in forms for subjects.

This permission must be assigned in conjunction with other permissions related to data collection, so the site user can view and complete forms.

This is a permission for both sponsor and site users.

Clinical Data Collection

View Queries

Lets you view queries raised against answer fields in forms.

This permission must be assigned in conjunction with other permissions related to query management, so a user can view, answer, create, or close queries.

This is a permission for both sponsor and site users.

Data Extract

Execute ODM Administrative Data API

Lets you use specific API endpoints to extract administrative data in an ODM-XML format.

This permission is available for sponsor users only.

Data Extract

Execute ODM Clinical Data API with Hidden Data

Lets you 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.

Data Extract

Execute ODM Clinical Data API without Hidden Data

Lets you 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.

Data Extract

Execute ODM Metadata API

Lets you use specific API endpoints to extract API Metadata in an ODM-XML format.

This permission is available for sponsor users only.

Data Extract

Run the Subject Data Extract

Lets you extract study data in a CSV, XPORT, and CPORT format by running the Subject Data Extract.

This permission is available for sponsor users only.

Inventory Management

Create Manual Shipments

Lets you create manual shipments to be delivered to sites.

Must be assigned along with the following permissions:
  • View Sites
  • View Site Inventory
  • View Shipments 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.
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)

Inventory Management

Create Shipments to Depots

Lets you create a supplying or a destruction shipment to be sent to another depot.

Can unblind users. Use with caution.

Inventory Management

Perform Supplies Reconciliation at Site

Lets you perform kit reconciliation at a site.

Must be assigned along with the following permissions:
  • View Sites
  • View Site Inventory

This permission is for both sponsor and site users.

Inventory Management

Receive New Shipments at the Depot

Lets you register shipments and add them to a depot's inventory.

Can unblind users. Use with caution.

Inventory Management

Receive Shipments and Update Site Inventory

Lets you receive shipments at a site and update the site inventory.

Must be assigned along with the following permissions:
  • View Sites
  • View Site Inventory
  • View Shipments to Sites

This permission is for site users, can be assigned to sponsor users, too.

Inventory Management

Receive and Reconcile Shipments at the Depot

Lets you receive shipments sent by a depot and reconciling shipments at a depot level.

Must be assigned along with the following permissions:
  • View Depots
  • View Sites

Can unblind users. Use with caution.

Inventory Management

Release Shipments from Quarantine

Allows you to release all kits in a shipment from Quarantine and update their status to Available.

This permission is for Clinical Supply Managers and sponsor users.
Inventory Management Update the Shipment Order Form Allows you to restrict sites' ability to resend depot order forms after orders have been fulfilled.

Must be assigned along with the Receive and Reconcile Shipments at the Depot permission.

This permission is for Clinical supply managers and sponsor users.

Inventory Management

Update Supplies after Design Approval

Lets you update study supplies settings after the study version has been moved to the Approved container.

Can unblind users. Use with caution.

Inventory Management

View Shipments to Sites

Lets you view shipments sent to sites.

Must be assigned along with the View Site Inventory permission.

This permission is for both sponsor and site users.

Inventory Management

View Site Inventory

Lets you view a site's inventory.

This permission is for both sponsor and site users.

Inventory Management

View Unblinded Pharmacist Kits

Lets you view unblinded pharmacist kits in both inventories: site and study inventory.

Must be assigned along with the following permissions:
  • View Sites
  • View Depots
  • View Site Inventory
  • Manage Study Inventory for Unblinded Users

Can unblind users. Use with caution.

Notifications

Receive Notification of Depot Shipments

Lets you receive a notification whenever a depot shipment is created or updated.

Can unblind users. Use with caution.

Notifications

Receive Notification of Shipments

Lets you 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.

Notifications

Receive Site has been Updated Notification

Lets you 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.

Notifications

Receive the Code Break Notification

Lets you receive a notification when a subject is unblinded due to a code break.

This permission is for both sponsor and site users.

Notifications

Receive the Dispensation Notification

Lets you receive the Subject Dispensation notification, whether the dispensation succeeded or failed.

This permission is for both sponsor and site users.

Notifications

Receive the Dispensation with Dosing Instructions Notification

Lets you 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.

Notifications

Receive the Randomization Notification

Lets you receive a notification when a subject is either successfully randomized or their randomization failed at a site that you are assigned to.

This permission is for both sponsor and site users.

Notifications Receive Rule Failure Notification for Locked Data Lets you receive a notification when a rule is unable to update a target because it is locked. This permission is for sponsor users.

Notifications

Receive the Study Limits Notification

Lets you 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.

Notifications Receive the Subject Completion Notification Lets you receive a notification when a subject at a site that you are assigned to completes a study. This is a permission for sponsor users.
Notifications Receive the Subject Rollover Notification Lets you receive a notification when a subject at a site that you are assigned to is enrolled into a rollover study. This is a permission for sponsor users.

Notifications

Receive the Subject Screening Notification

Lets you receive a notification when a subject is either successfully screened or their screening failed at a site that you are assigned to.

This permission is for both sponsor and site users.

Notifications

Receive the Subject Transferred Notification

Lets you receive a notification when a subject transfers to another site.

This permission is for both sponsor and site users.

Notifications Receive the Subject Number Update Notification Lets you receive a notification when a subject's number is updated in a system. This permission is for both sponsor and site users.

Notifications

Receive the Subject Visit Notification

Lets you receive a notification when a subject completes a non-dispensation or optional visit at a site that you 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.

Notifications

Receive the Subject Withdrawal Notification

Lets you receive a notification when a subject withdraws from a study.

This permission is for both sponsor and site users.

Notifications

Receive the Unblinded Dispensation Notification

Lets you receive a notification when an unblinded dispensation event is successfully completed or when the unblinded dispensation failed at a site that you are assigned to.

This permission is for both sponsor and site users.

Can unblind users. Use with caution.

Notifications

Receive the Unblinded Pharmacist Dispensation Notification

Lets you 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.

Can unblind users. Use with caution.

Notifications

Receive the Unblinded Randomization Notification

Lets you receive a notification when a subject is either successfully randomized with unblinded kits or their unblinded randomization failed at a site that you are assigned to.

This permission is for both sponsor and site users.

Can unblind users. Use with caution.

Notifications Receive the Unscheduled Visit Notification

Lets you receive a notification when a subject completes an unscheduled visit at a site that you are assigned to. The notification is sent both when the subject successfully completes the visit and when one or more questions have errors.

This is a permission for sponsor users.
Reports Schedule Reports to Run Lets you access the Schedule Reports side panel to create automated schedules for specific reports. This permission is for Sponsor users and should only be granted to one Sponsor level user.

Reports

Run the Blinded Chain of Custody Report

Lets you run the Kit Chain of Custody (blinded) report.

This permission is for both sponsor and site users.

Can unblind users. Use with caution.

Reports

Run the Blinded Inventory Report

Lets you run the Blinded Inventory report.

This permission is for both sponsor and site users.

Reports

Run the Blinded Subject Events Dataset

Lets you operate the Blinded Subject Events Dataset in Oracle Clinical One Analytics

This permission is for both sponsor and site users.

Reports

Run the Enrollment Report

Lets you run the Study Enrollment report.

This permission is for both sponsor and site users.

Reports

Run the Kit Dispensation Report

Lets you run the Kit Dispensation report.

This permission is for both sponsor and site users.

Reports

Run the Kit Reconciliation Report

Lets you run the Kit Reconciliation report.

This permission is for both sponsor and site users.

Reports

Run the Order Summary Report

Lets you run the Shipment Order Summary report.

This permission is for both sponsor and site users.

Reports

Run the Site and Depot Report

Lets you run the Audit Report Site and Depot report.

This permission is for both sponsor and site users.

Reports

Run the Study Codelist Dataset

Planned for a future release.

This permission is for both sponsor and site users.

Reports

Run the Study Design Report

Lets you run the Study Design report.

This permission is for both sponsor and site users.

Reports

Run the Study Query Dataset

Lets you operate the Study Query dataset in Oracle Clinical One Analytics

This permission is for both sponsor and site users.

Reports

Run the Study Rules Report

Lets you run the Rules report.

This permission is for both sponsor and site users.

Reports

Run the Subject Data Report

Lets you run the Subject Data report.

This permission is for both sponsor and site users.

Reports

Run the Subject Data for CTMS Report

Lets you run the Subject Data for CTMS report.

This permission is for both sponsor and site users.

Reports

Run the Subject Dataset

Lets you operate the Subject dataset in Oracle Clinical One Analytics

This permission is for both sponsor and site users.

Reports

Run the Subject Events Report

Lets you run the Subject Events report.

This permission is for both sponsor and site users.

Reports

Run the Subject Form Items Dataset

Lets you operate the Subject Form Items dataset in Oracle Clinical One Analytics

This permission is for both sponsor and site users.

Reports

Run the Subject Forms Dataset

Lets you operate the Subject Forms dataset in Oracle Clinical One Analytics

This permission is for both sponsor and site users.

Reports

Run the Subject Query Report

Lets run the Subject Queries report.

This permission is for both sponsor and site users.

Reports

Run the Subject Visit Report

Lets you run the Subject Visits report (Blinded).

This permission is for both sponsor and site users.

Reports

Run the Titration Summary Report

Lets you run the Titration Summary report (Blinded).

This permission is for both sponsor and site users.

Reports

Run the Training Report

Lets you run the Clinical One Training report.

This permission is for both sponsor and site users.

Reports

Run the Unblinded Chain of Custody Report

Lets you run the Kit Chain of Custody (Unblinded) report.

This permission is for both sponsor and site users.

Can unblind users. Use with caution.

Reports

Run the Unblinded Kits Dataset

Lets you run the Unblinded Kits Dataset.

This permission is for sponsor users only.

Can unblind users. Use with caution.

Reports

Run the Unblinded Randomization Report

Lets you run the Randomization List report (Unblinded).

This permission is for both sponsor and site users.

Can unblind users. Use with caution.

Reports

Run the Unblinded Subject Events Dataset

Lets you operate the Unblinded Subject Events dataset in Oracle Clinical One Analytics

This permission is for both sponsor and site users.

Can unblind users. Use with caution.

Reports

Run the Unblinded Subject Visit Schedule Report

Lets you run the Subject Visits (Unblinded) report.

This permission is for both sponsor and site users.

Can unblind users. Use with caution.

Reports

Run the Unblinded Titration Summary Report

Lets you run the Titration Summary (Unblinded) report.

This permission is for both sponsor and site users.

Can unblind users. Use with caution.

Reports

Run the User Assignment Report

Lets you run the User Assignment and User Assignment by Site reports.

This permission is for both sponsor and site users.

Reports Run the Kits and Randomization Design Dataset Lets you operate the Kits and Randomization Design dataset in Oracle Clinical One Analytics This permission is for sponsor users only.
Reports Run the Data Collection Design Dataset Lets you run the Study Design Delta report and operate the Data Collection Design dataset in Oracle Clinical One Analytics This permission is for sponsor users only.

Rules Management

Design Custom Rules

Lets a rule designer design custom JavaScript rules.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects
  • Edit Form Data for Subjects

This permission is for sponsor users only.

Rules Management

Publish Custom Rules

Lets a rule publisher publish custom rules.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects
  • Edit Form Data for Subjects

This permission is for sponsor users only.

Rules Management

Re-run Rules

Lets a sponsor user re-run a rule that was modified during the study conduct period.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects
  • Edit Form Data for Subjects

This permission is for sponsor users only.

Rules Management

Test Custom Rules

Lets a rule tester test custom rules built by a rule designer.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects
  • Edit Form Data for Subjects

This permission is for sponsor users only.

Settings

Configure Connected Device Study Settings

Lets you 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.

Must be assigned along with the View Study Settings permission.

This permission is for sponsor users only.

Settings Edit Welcome Details in General Study Settings Lets you customize the welcome letter that study team members receive upon being provisioned in a study in the application. This permission gives you the ability to edit the Welcome Letter field for an individual study. This permission is for Sponsor users only. To customize the welcome letter for all studies at your organization, you must be assigned the Study Creator global role.
Study Design Upload Users in Bulk Lets you download and import the User Upload Template and access the User Upload Error report. This permission is for Sponsor users only.

Study Management

Answer Assigned Queries

Lets you answer queries that are assigned to a specific user role.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects
  • View All Queries

This permission is for sponsor users only.

Study Management

Close Queries

Lets you close queries in a study.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects
  • View Queries
  • View All Queries

This permission is for sponsor users only.

Study Management

Create Candidate Queries

Lets you create candidate queries against answer fields.

  • View Sites
  • View Form Data for Subjects
  • View Queries
  • View All Queries

This permission is for sponsor users only.

Study Management

Create Queries

Lets you create queries (not assigned queries that must be assigned to a specific use role). A regular query appears for any user who has either one of these permissions:
  • View Queries
  • View All Queries
The Create Queries permission must be assigned along with these other permissions:
  • View Sites
  • View Form Data for Subjects

This permission is for sponsor users only.

Study Management

Create Shipments to DDF

Lets you create a shipment that must be sent to a drug-destruction facility.

Must be assigned along with the following permissions:
  • View Depots
  • View Shipments to Sites
  • Manage Study Inventory for Unblinded Users

This permission is for both sponsor and site users.

Study Management

Delete Candidate Queries

Lets you delete candidate queries created by a sponsor user.

Must be assigned along with the following permissions:
  • View All Queries
  • View Queries
  • View Sites
  • View Form Data for Subjects

This permission is for sponsor users only.

Study Management

Perform Source Data Verification and Reconcile Inventory

This permission lets you perform two tasks:
  • Perform source data verification according to the configured source data verification strategy;
  • Perform kit reconciliation in the...
Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects
  • View Queries

This permission is for sponsor users only.

Study Management

Transfer subjects between sites

Lets you transfer a subject from one site to another.

Must be assigned along with the following permissions:
  • View Sites
  • View Form Data for Subjects

This permission is for sponsor users only.

Study Management

View All Queries

Lets you view all queries in a study, including queries assigned to a specific user role.

Must be assigned along with the permissions:
  • View Sites
  • View Form Data for Subjects

This permission is for both sponsor and site users.

Study Setup

Assign a Resupply Strategy to a Depot

Lets you assign a min/max resupply strategy to a depot.

This permission is for sponsor users only.

Study Setup

Assign a Resupply Strategy to a Site

Lets you assign a resupply strategy to a site.

Must be assigned along with the following permissions:
  • View Sites
  • Create and Manage Sites

This permission is for sponsor users only.

Study Setup

Assign a SDV Strategy to a Site

Lets you assign an SDV strategy to a site.

Must be assigned along with the following permissions:
  • View Sites
  • Create and Manage Sites
  • Create and Manage SDV Strategies

This permission is for sponsor users only.

Study Setup

Assign a Study Version to a Site

Lets you assign a study version to a site.

Must be assigned along with the following permissions:
  • View Sites
  • Create and Manage Sites

This permission is for sponsor users only.

Study Setup

Create and Manage Depots

Lets you create and manage depots.

Must be assigned along with the following permissions:
  • View Depots

This permission is for sponsor users only.

Study Setup

Create and Manage Lots

Lets you create and manage lots.

Can unblind users. Use with caution.

Study Setup

Create and Manage SDV Strategies

Lets you create and manage source data verification strategies.

This permission is for sponsor users only.

Study Setup

Create and Manage Sites

Lets you create and manage sites.

Must be assigned along with the View Sites permission.

This permission is for sponsor users only.

Study Setup

Edit General Study Settings

Lets you edit study settings located on the General tab.

This permission is for sponsor users only.

Study Setup

Edit Regions

Lets you edit regions in a study.

Must be assigned along with the View Study Settings permission.

This permission is for sponsor users only.

Study Setup

Edit Study Settings

Lets you edit study settings located on the Study Settings tab.

Must be assigned along with the View Study Settings permission.

This permission is for sponsor users only.

Study Setup

Edit Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies

Lets you edit supply settings, blinded groups, label groups, and resupply strategies located on the Supply Settings tab.

Must be assigned along with the View Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies permission.

This permission is for sponsor users only.

Study Setup

Move a Study Design to Testing or Production

Lets you move a study version from Draft to Testing and from Testing to Production.

This permission is for sponsor users only.

Study Setup

Upload and Generate Inventory Lists

Lets you upload and generate kit lists.

Must be assigned along with the View Study Design permission.

This permission is for sponsor users only.

Study Setup

Upload and Generate Randomization Lists

Lets you upload and generate randomization lists.

Must be assigned along with the View Study Design permission.

This permission is for sponsor users only.

Study Setup

View Depots

Lets you view depots in a study.

This permission is for sponsor users only.

Study Setup

View Regions

Lets you view regions in a study.

Must be assigned along with the View Study Settings permission.

This permission is for sponsor users only.

Study Setup

View Role Assignments for Study Users

Lets you view what roles and permissions are assigned to users in a study that you are a part of.

This permission is for sponsor users only.

Study Setup

View Sites

Lets you view sites created in a study.

This permission is for sponsor users only.

Study Setup

View Study Design

Lets you view all study design elements in the Draft version of a study. 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.

Study Setup

View Study Settings

Lets you view all fields and settings located on the Study Settings tab.

This permission is for sponsor users only.

Study Setup

View Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies

Lets you view all fields and settings located on the Supply Settings tab.

This permission is for sponsor users only.

Trial Management Close Trial Management Events Lets you close any events related to the management of your study. Planned for a future release.
Trial Management Create Actions on Trial Management Event Records Lets you create actions for every trial management event record in the system. Planned for a future release.
Trial Management Create Trial Management Event Records Lets you create records for every trial management event. Planned for a future release.
Trial Management Create Trial Management Event Records from Subjects Tab Lets you create a trial management event record on the Subjects page. Planned for a future release.

This permission can also be assigned to a site user.

Trial Management Create Unblinded Trial Management Records Lets you create unblinded trial management records in your study. Planned for a future release.

Can unblind users. Use with caution.

Trial Management Edit Actions on Trial Management Event Records Lets you edit the associated actions of a trial management event record. Planned for a future release.
Trial Management Edit Trial Management Event Records Lets you edit records for trial management events. Planned for a future release.
Trial Management Edit Trial Management Event Records from Subjects Tab Lets you edit records for trial management events on the Subjects page. Planned for a future release.

This permission can also be assigned to a site user.

Trial Management Edit Unblinded Trial Management Records Lets you edit unblinded record of trial management. Planned for a future release.

Can unblind users. Use with caution.

Trial Management Open Trial Management Events Lets you open new trial management events. Planned for a future release.
Trial Management View Actions on Trial Management Event Records Lets you view records of trial management events. Planned for a future release.
Trial Management View Blinded Trial Management Records Lets you view blinded records of trial management. Planned for a future release.
Trial Management View Trial Management Event Records Lets you view all records of trial management events. Planned for a future release.
Trial Management View Trial Management Event Records from Subjects Tab Lets you view records of trial management events on the Subjects page. Planned for a future release.
Trial Management View Trial Management Event Records with Actions Assigned to me Lets you view records of trial management events with actions assigned to your user in the system. Planned for a future release.
Trial Management View Unblinded Trial Management Records Lets you view unblinded record of trial management. Planned for a future release.

Can unblind users. Use with caution.

Unblinded Study Management

Manage Randomization Lists

Lets you update randomization lists.

Must be assigned along with the following permissions:
  • View Study Design
  • Upload and Generate Randomization Lists

This permission is for sponsor users only.

Can unblind users. Use with caution.

Unblinded Study Management

Manage Study Inventory for Unblinded Users

Lets you manage kits and shipments on the Study Inventory tab.

Can unblind users. Use with caution.

This permission is for sponsor users only.

Unblinded Study Management

Reveal the Treatment Arm for a Subject or Code View

Lets you perform a code view for a subject.

Can unblind users. Use with caution.

This permission is for sponsor users only.

Unblinded Study Management

Update Inventory Lists

Lets you update kit lists.

Must be assigned along with the following permissions:
  • View Study Design
  • Upload and Generate Inventory Lists

Can unblind users. Use with caution.

This permission is for sponsor users only.

Design permissions

Permission Description Notes

Add and Administer Study Users

Lets you add and manage users created in a study.

None.

Create Study Roles

Lets you create custom study roles.

None.

Delete Custom Code Lists

Lets you remove code lists.

None.

Design Forms

Lets you design all elements of a form, whether it is a one-section form, a two section form, a lab form, and many more.

None.

Design Randomization

Lets you design all elements of a randomization.

None.

Design SDV Properties on Forms

Lets you specify SDV properties for each question in a form.

None.

Design Supplies and Dispensation

Lets you design kit types and treatment arms.

None.

Design Visits and Events

Lets you design all available types of visits and events.

None.

Manage Study Code Lists Lets you create and manage system and custom code lists for the study that you are assigned to. None.

Run the Draft Study Design Report

Lets you run the Study Design report in Draft.

None.

Run the Study Roles and User Assignment Report (Design Mode)

Lets you run the Study Roles and User Assingment reports in Draft.

None.

View Design

Lets you view a study's design in Draft.

None.