3 Accounts, user roles, and environment access

The Release Assessment Environment comes with pre-defined study roles so you can easily review new features using multiple roles.

Accounts and user roles

Note:

For new study designer accounts it is a best practice to request both the Assessment Designer and Assessment Tester roles be associated to the account. This will allow the study designer to verify their study design prior to having other users start testing.

Tip:

Refer to the Ticketing details section below to see how to complete a request.

Create tickets in the Oracle Life Sciences Support Cloud to request the following:

• Access to the Release Assessment Environment (RAE)
• Additional user accounts
• Change a study role for a user
• Terminate a user account.

  Caution:

  It is the customer's responsibility to ensure active user accounts in the Oracle Clinical One Platform Release Assessment Environment are terminated should a member of your team leave your organization.

Accessing the Release Assessment Environment

Users receive the following emails the Release Assessment Environment as Customer Release Assessment and include a reference to the tenant used in the environment, CUSTREL.

The account details in the emails are different or separate from the account details tied to your organizations-specific tenant. The credentials in these emails only allow you to access the Release Assessment Environment.

• Users receive an email with the subject, Oracle Life Sciences Cloud – New Account in Customer Release Assessment. This email contains their Oracle Life Sciences single sign-on (SSO) account log in name and instructions to setup a password.

  Note:

  If you need to reset your password after the initial setup, use the Trouble Signing In? link that is available when you first log in to the Release Assessment Environment.
• The Release Assessment Environment URL is provided in a separate email with the subject, Access Information for the xxxx study in Clinical One. This email contains the link, Sign in to your study.
• If you experience any issues logging in after following the steps above, refer to section 5 Support in this guide for details opening a Support Request (SR).

Ticketing details

1. Log in to Oracle Life Sciences Support Cloud.
2. Click Create Request in the upper-right corner, then select Support Request.
3. Complete the fields as defined below:

Table 3-1 Ticketing information

Field	Description
Summary for environment access	Requesting initial access to the Release Assessment Environment
Description for environment access	Include first name, last name, email address and the desired study role for each Study Mode (Design, Testing, Production and Training). Note: Study role names can be found in the table below.
Summary for additional accounts	Requesting additional Clinical One Release Assessment Environment user accounts
Description for additional accounts	Include first name, last name, email address and the desired study role for each Study Mode (Design, Testing, Production and Training).
Summary for a study role change	Requesting a change in study role for the Clinical One Release Assessment Environment
Description for a study role change	Include first name, last name, email address, new study role to be assigned for each Study Mode (Design, Testing, Production and Training), and the study(s) in which the role should be changed.
Summary for user termination	Requesting user termination for the Clinical One Release Assessment Environment
Description for user termination	Include first name, last name, email address, and the termination date (effective immediately or scheduled date) for the user to be terminated.
Severity	3 - Medium
Issue Category	User Roles and Privileges
Customer	Customer name
Product	Clinical One
Business Service	Clinical One - customer name
Environment	Assessment

Roles and permissions

• Permissions cannot be added or removed.
• Roles with the View Role Assignments for Study Users permission can view the permissions assigned to each role.

Table 3-2 Default roles and permissions

Clinical One Study Roles	Permissions assigned
Assessment Clinical Research Associate (CRA)	Answer Assigned Queries Assign a Resupply Strategy to a Site Assign a SDV Strategy to a Site Assign a Study Version to a Site Close Queries Create and Manage SDV Strategies Create and Manage Sites Create Candidate Queries Create Queries Create Shipments to DDF Delete Candidate Queries Edit Classified Subject Data Only Edit Regions Edit Study Settings Manage Archives Settings Manage Signature Settings Move a Study Design to Testing or Production Perform Source Data Verification and Reconcile Inventory Perform Supplies Reconciliation at Site Receive Rule Failure Notification for Locked Data Receive Site has been Updated Notification Receive the Code Break Notification Receive the Pending Signatures Notification Receive the Study Limits Notifications Receive the Subject Number Update Notification Receive the Subject Transferred Notification Receive the Subject Withdrawal Notification Run and download all PDF request types and Audit reports. Enable Share with Sites, and Site Confirmation Run and download Site Confirmation and Download Log audit reports Run the Blinded Inventory Report Run the Blinded Randomization Report Run the Blinded Subject Events Dataset Run the Enrollment Report Run the Kit Dispensation Report Run the Kit Reconciliation Report Run the Order Summary Report Run the Site and Depot Report Run the Study Codelist Dataset Run the Study Design Report Run the Study Kits Dataset Run the Study Query Dataset Run the Study Roles Report Run the Study Rules Report Run the Subject Data Extract Run the Subject Data Report Run the Subject Dataset Run the Subject Events Report Run the Subject Form Items Dataset Run the Subject Forms Dataset Run the Subject Query Report Run the Subject Visit Report Run the Titration Summary Report Run the Training Report Run the User Assignment Report Transfer subjects between sites Update Subject Number after Creation Verify subject data entered at a site View Blinded Dispensation Details with Calculated Doses View Classified Subject Data Only View Depots View Form Data for Subjects View Queries View Regions View Role Assignments for Study Users View Shipments to Sites View Site Inventory View Sites View Study Design View Study Settings
Assessment Clinical Supply Manager (CSM)	Answer Assigned Queries Assign a Resupply Strategy to a Depot Assign a Resupply Strategy to a Site Assign a SDV Strategy to a Site Assign a Study Version to a Site Create and Manage Depots Create and Manage Dispensation Exceptions Create and Manage Lots Create and Manage Sites Create Manual Shipments Create Manual Shipments (Unblinded) Create Shipments to Depots Edit Classified Subject Data Only Edit Regions Edit Study Settings Edit Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies Manage Randomization Lists Manage Study Inventory for Unblinded Users Move a Study Design to Testing or Production Receive and Reconcile Shipments at the Depot Receive New Shipments at the Depot Receive Notification of Depot Shipments Receive Notification of Shipments Receive Site has been Updated Notification Receive the Quarantined Depot Shipment Notification Receive the Quarantined Site Shipment Notification Receive the Released from Quarantine Notification (Depot) Receive the Study Limits Notifications Receive the Unblinded Dispensation Notification Release Shipments from Quarantine Reveal the Treatment Arm for a Subject, or Code View Run the Blinded Chain of Custody Report Run the Blinded Inventory Report Run the Blinded Randomization Report Run the Blinded Subject Events Dataset Run the Enrollment Report Run the Kit Dispensation Report Run the Kit Reconciliation Report Run the Order Summary Report Run the Site and Depot Report Run the Study Codelist Dataset Run the Study Design Report Run the Study Kits Dataset Run the Study Query Dataset Run the Study Roles Report Run the Study Rules Report Run the Subject Data Extract Run the Subject Data Report Run the Subject Dataset Run the Subject Events Report Run the Subject Form Items Dataset Run the Subject Forms Dataset Run the Subject Query Report Run the Subject Visit Report Run the Titration Summary Report Run the Training Report Run the Unblinded Chain of Custody Report Run the Unblinded Inventory Report Run the Unblinded Kits Dataset Run the Unblinded Randomization Report Run the Unblinded Subject Events Dataset Run the Unblinded Subject Visit Schedule Report Run the Unblinded Titration Summary Report Run the User Assignment Report Update Inventory Lists WARNING: Users with this permission can make supply updates that may be detrimental to your study. For more information, see Descriptions of permissions in Clinical One. Update Supplies after Design Approval WARNING: Users with this permission can make supply updates that may be detrimental to your study. For more information, see Descriptions of permissions in Clinical One. Update the Shipment Order Form Upload and Generate Inventory Lists Upload and Generate Randomization Lists View All Queries View Blinded Dispensation Details with Calculated Doses View Blinded Dispensation Details without Calculated Doses View Classified Subject Data Only View Depots View Form Data for Subjects View Regions View Role Assignments for Study Users View Shipments to Sites View Site Inventory View Sites View Study Design View Study Settings View Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies
Assessment Data Manager (DM)	Add a Lab to a Site Add and Update Lab Normal Ranges Answer Assigned Queries Assign a SDV Strategy to a Site Assign a Study Version to a Site Close Queries Create and Add Labs to a Site Create and Manage SDV Strategies Create Candidate Queries Create Queries Delete Candidate Queries Edit Classified Subject Data Only Freeze subject data entered at a site Lock subject data entered at a site Receive the Study Limits Notifications Receive the Subject Completion Notification Receive the Subject Number Update Notification Receive the Subject Rollover Notification Receive the Subject Withdrawal Notification Receive the Unscheduled Visit Notification Run and download Site Confirmation and Download Log audit reports Run the Blinded Inventory Report Run the Blinded Randomization Report Run the Blinded Subject Events Dataset Run the Enrollment Report Run the Kit Dispensation Report Run the Kit Reconciliation Report Run the Order Summary Report Run the Site and Depot Report Run the Study Codelist Dataset Run the Study Design Report Run the Study Kits Dataset Run the Study Query Dataset Run the Study Roles Report Run the Study Rules Report Run the Subject Data Extract Run the Subject Data Report Run the Subject Dataset Run the Subject Events Report Run the Subject Form Items Dataset Run the Subject Forms Dataset Run the Subject Query Report Run the Subject Visit Report Run the Titration Summary Report Run the Training Report Run the User Assignment Report Schedule Reports to Run Unfreeze subject data entered at a site View Blinded Dispensation Details with Calculated Doses View Blinded Dispensation Details without Calculated Doses View Classified Subject Data Only View Depots View Form Data for Subjects View Queries View Regions View Role Assignments for Study Users View Shipments to Sites View Site Inventory View Sites View Study Design View Study Settings
Assessment Designer	Assignment Report (Design Mode) Design Clinical Supplies Form Design Forms Design Randomization Design SDV Properties on Forms Design Supplies and Dispensation Design Visits and Events Manage Study Code Lists Run the Analytics Study Codelist Dataset Run the Data Collection Design Dataset Run the Draft Study Design Report Run the Kits and Randomization Design Dataset Run the Study Roles and User View Design
Assessment Tester	Add a Lab to a Site Add and Update Lab Normal Ranges Approve and Sign Assigned Data Only Assign a Resupply Strategy to a Site Assign a SDV Strategy to a Site Assign a Study Version to a Site Create and Add Labs to a Site Create and Manage Depots Create and Manage Lots Create and Manage SDV Strategies Create and Manage Sites Design Custom Rules Dispense Kits with Calculated Doses Edit Classified Subject Data Only Edit Form Data for Subjects Edit General Study Settings Edit Regions Edit Study Settings Edit Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies Edit Visit Dates Manage Randomization Lists Manage Signature Settings Manage Study Inventory for Unblinded Users Move a Study Design to Testing or Production Publish Custom Rules Randomize Subjects Receive and Reconcile Shipments at the Depot Receive Notification of Shipments Receive Site has been Updated Notification Receive the Code Break Notification Receive the Dispensation Notification Receive the Dispensation with Dosing Instructions Notification Receive the Pending Signature Notification Receive the Randomization Notification Receive the Study Limits Notifications Receive the Subject Screening Notification Receive the Subject Transferred Notification Receive the Subject Visit Notification Receive the Subject Withdrawal Notification Receive the Unblinded Dispensation Notification Receive the Unblinded Pharmacist Dispensation Notification Receive the Unblinded Randomization Notification Re-run Rules Reveal the Treatment Arm for a Subject, or Code View Run and download all PDF request types and Audit reports. Enable Share with Sites, and Site Confirmation Run and download Site Confirmation and Download Log audit reports Run the Blinded Inventory Report Run the Blinded Subject Events Dataset Run the Enrollment Report Run the Kit Dispensation Report Run the Kit Reconciliation Report Run the Order Summary Report Run the Site and Depot Report Run the Study Codelist Dataset Run the Study Design Report Run the Study Kits Dataset Run the Study Query Dataset Run the Study Roles Report Run the Study Rules Report Run the Subject Data Extract Run the Subject Data Report Run the Subject Dataset Run the Subject Events Report Run the Subject Form Items Dataset Run the Subject Forms Dataset Run the Subject Query Report Run the Subject Randomization Data Extract Report Run the Subject Visit Report Run the Titration Summary Report Run the Training Report Run the Unblinded Chain of Custody Report Run the Unblinded Inventory Report Run the Unblinded Kits Dataset Run the Unblinded Randomization Report Run the Unblinded Subject Events Dataset Run the Unblinded Subject Visit Schedule Report Run the Unblinded Titration Summary Report Run the User Assignment Report Skip Visits Test Custom Rules Unblind the Treatment Arm for a Subject, or Code Break Update Inventory Lists WARNING: Users with this permission can make supply updates that may be detrimental to your study. For more information, see Descriptions of permissions in Clinical One. Upload and Generate Inventory Lists Upload and Generate Randomization Lists View All Queries View Blinded Dispensation Details with Calculated Doses View Classified Subject Data Only View Form Data for Subjects View Queries View Role Assignments for Study Users View Shipments to Sites View Site Inventory View Sites View Study Design View Study Settings View Supply Settings, Blinded Groups, Label Groups, and Resupply Strategies View Unblinded Pharmacist Kits
Assessment PI Role	Add a Lab to a Site Add and Update Lab Normal Ranges Answer Assigned Queries Answer Queries Approve and Sign Assigned Data Only Approve and sign subject data Confirm download of Archival PDFs and content Create and Add Labs to a Site Create Shipments to DDF Dispense Kits with Calculated Doses Dispense Kits without Calculated Doses Download Archival PDFs, and Audit Reports Edit Classified Subject Data Only Edit Form Data for Subjects Edit Visit Dates Randomize Subjects Receive Notification of Shipments Receive Shipments and Update Site Inventory Receive the Code Break Notification Receive the Dispensation Notification Receive the Dispensation with Dosing Instructions Notification Receive the Pending Signature Notification Receive the Quarantined Site Shipment Notification Receive the Randomization Notification Receive the Released from Quarantine Notification (Site) Receive the Subject Number Update Notification Receive the Subject Screening Notification Receive the Subject Transferred Notification Receive the Subject Visit Notification Receive the Subject Withdrawal Notification Run Archival PDFs for your site(s) Run the Blinded Inventory Report Run the Enrollment Report Run the Kit Dispensation Report Run the Kit Reconciliation Report Run the Order Summary Report Run the Subject Data Report Run the Subject Events Report Run the Subject Query Report Run the Subject Visit Report Run the Titration Summary Report Run the Training Report Run the User Assignment Report Skip Visits Unblind the Treatment Arm for a Subject, or Code Break View Blinded Dispensation Details with Calculated Doses View Blinded Dispensation Details without Calculated Doses View Classified Subject Data Only View Form Data for Subjects View Queries View Shipments to Sites View Site Inventory
Assessment Unblinded Site User	Create Manual Shipments Create Shipments to DDF Edit Classified Subject Data Only Perform Supplies Reconciliation at Site Receive Notification of Shipments Receive Shipments and Update Site Inventory Receive the Code Break Notification Receive the Dispensation with Dosing Instructions Notification Receive the Quarantined Site Shipment Notification Receive the Released from Quarantine Notification (Site) Receive the Subject Number Update Notification Receive the Unblinded Pharmacist Dispensation Notification Run the Blinded Inventory Report Run the Blinded Randomization Report Run the Enrollment Report Run the Kit Dispensation Report Run the Kit Reconciliation Report Run the Order Summary Report Run the Subject Data Report Run the Subject Events Report Run the Titration Summary Report View Blinded Dispensation Details with Calculated Doses View Blinded Dispensation Details without Calculated Doses View Classified Subject Data Only View Form Data for Subjects View Shipments to Sites View Site Inventory View Unblinded Pharmacist Kits