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
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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
- Update Supplies after Design Approval
- 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
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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
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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
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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
- 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
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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
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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
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