Home

Task Alerts

150

W

Home page

Site Users

Sponsor Users

Contact Information

501

W

Contact Information page

Site Users

Sponsor Users

Notifications

301

W

Notifications page

Site Users

Sponsor Users

Subjects

Subject Transactions

200

P/W

Subject Transactions page

Site Users

Sponsor Users

Subject Transfer

213

W

Subject Transfer page

Sponsor Users

Screening

Screening

201

P/W

Screening tasks on the Subject Transactions page

Site Users

Subject Approval

Subject Out of Window Approval

210

W

Out-of-window approval tasks on the Subject Transactions page

Sponsor Users

Subject Transactions

Screen Fail

202

P/W

Screen failure tasks on the Subject Transactions page

Site Users

Randomization

203

P/W

Randomization tasks on the Subject Transactions page

Site Users

Scheduled Visit

204

P/W

Scheduled Visit tasks on the Subject Transactions page

Site Users

Drug Replacement

217

P/W

Drug Replacement tasks on the Subject Transactions page

Site Users

Early Termination

206

P/W

Early Terminations tasks on the Subject Transactions page

Site Users

Completion

211

P/W

Subject Completion tasks on the Subject Transactions page

Site Users

Unblind Treatment

207

P/W

UNBLINDING tasks on the Subject Transactions page

Investigator, Safety or Medical Monitor ONLY

Flag Subject

291

W

Flag a subject as misrandomized or off-treatment on the Subject Transactions page

Sponsor Users

Set-Up (Supplies)

Depots

620

W

Depots page

Sponsor Users

Depot Association

623

W

Depot Association page

UNBLINDED USERS ONLY Sponsor Users (Drug Supply Manager)

Lots & Expiry

606

W

Lots & Expiry page

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Manufacturing Lot

619

W

Manufacturing Lot page

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Lot Association

624

W

Lot Association page

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Label Groups

618

W

Label Groups page

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Label Group Association

625

W

Label Group Association page

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Inventory (Supplies)

Resupply Setting

605

W

Resupply Setting page

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Smart System

627

W

Smart System page

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Inventory Management

611

W

Inventory Management page

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Update Site Inventory

673

P/W

Update Site Inventory page

Site User (cannot undamage drugs)

Update Depot Inventory

643

P/W

Update Depot Inventory page

Depot User (cannot undamage drugs)

Drug Order (Supplies)

Order Transactions

600

W

Order Transactions

Site User and Sponsor User

Request Manual

609

W

Request Manual page

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Trial Supply Orders
(Supplies, Drug Orders)

Ship Information

614

W

Shipment details on the Order Transactions page

Depot User or Drug Supply Manager

Register Site Drug Order Receipt

663

P/W

Drug orders receipts on the Order Transactions page

Site User

Register Depot Drug Order Receipt

633

P/W

Drug orders receipts on the Depot page

Depot User

Initiate Cancel

638

W

Drug order cancelation tasks on the Order Transactions page

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Complete Cancel

639

W

Drug order cancelation tasks on the Order Transactions page

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Drug Accountability

Reconciliation by Site and Monitor

615

W

Reconciliation by Site and Monitor page

Site User and Field Monitor

Ready for Shipment or Destruction

616

W

Ready for Shipment or Destruction page

Site User and Field Monitor

Reconciliation by Return Depot

617

W

Reconciliation by Return Depot (DDF) page

DDF User

Study Set-Up

Study Limits

304

W

Study Limits page

Sponsor Users (Study Manager)

Randomization Schedule

302

W

Randomization Schedule page

UNBLINDED USERS ONLY (Statistician)

Drug Schedule

303

W

Drug Schedule page

UNBLINDED USERS ONLY (Statistician)

Role Notifications

504

W

Role Notifications page

Sponsor Users (Study Manager)

Manage Countries

307

W

Manage Countries page

Sponsor Users (Study Manager)

Manage Regions

308

W

Manage Regions page

Sponsor Users (Study Manager)

Users

Edit User

502

W

Edit User page

Sponsor Users

Link to Site/Depot

503

W

Link to Site/Depot page

Sponsor Users

User Upload

505

W

User Upload page

Sponsor Users

Pending Users

510

W

Pending Users page

Sponsor Users

Edit User

Edit Role

511

W

Edit role on Edit User page

Sponsor Users

Edit Site/Depot

512

W

Edit site/depot on Edit User page

Sponsor Users

Reset Password

513

W

Reset password on Edit User page

Sponsor Users

Lock/Unlock User

514

W

Lock user on Edit User page

Sponsor Users

Activate/Reactivate User

515

W

Deactivate user on Edit User page

Sponsor Users

Sites

Manage Sites

401

W

Can view Sites tab

Manage Sites page

Sponsor Users

Site Upload

405

W

Site Upload page

Sponsor Users

Manage Sites

Manage Site Information

402

W

Manage Sites page (site information)

Sponsor Users

Manage Site Activity

403

W

Manage Sites page

Activate/deactivate site

Manage site limits

Open and close the screening and randomization for site

Sponsor Users (Study Manager)

Manage Site Trial Supply Order Settings

404

W

Manage Sites page

Supply Type, Drug Ordering status

Sponsor Users (Drug Supply Manager)

Suspend Trial Supply Ordering

406

W

Manage Sites page

Drug Order Suspension tab

Sponsor Users (Drug Supply Manager)

Subject (Reports)

Subject Details

705

W

Subject Details report

Site Users

Sponsor Users

Subject Details Sponsor

720

W

Subject Details Sponsor report

Site Users

Sponsor Users

Visit Summary

706

W

Visit Summary report

Site Users

Sponsor Users

Randomization Report Unblinded

717

W

Randomization Report UNBLINDED report

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Edit Subject Data Report

713

W

Edit Subject Data report

Sponsor Users

Drug Reallocation

716

W

Drug Reallocation report

Sponsor Users

Visit Rollback Report

714

W

Visit Rollback report

Sponsor Users

Drug Reallocation Unblinded

722

W

Drug Reallocation UNBLINDED report

UNBLINDED users only

Study (Reports)

Enrollment Summary

701

W

Enrollment Summary report

Sponsor Users

Overall Summaries

702

W

Overall Summaries report

Sponsor Users

Site Overall & Monthly

704

W

Site Overall & Monthly report

Site Users

Sponsor Users

Site Statistics

703

W

Site Statistics

Site Users

Sponsor Users

Audit Site Reports

729

W

Audit Site report

Sponsor Users

Supplies (Reports)

Order Summary

707

W

Order Summary report

Site Users and Sponsor Users (such as Drug Supply Manager)

Site Inventory

708

W

Site Inventory report

Site Users and Sponsor Users (such as Drug Supply Manager)

Site Inventory Unblinded

718

W

Site Inventory UNBLINDED report

UNBLINDED users only (Unblinded Drug Supplies Manager)

Depot Inventory

709

W

Depot Inventory report

Depot User and Drug Supplies Manager

Depot Inventory Unblinded

719

W

Depot Inventory UNBLINDED report

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Depot Inventory by Unit Unblinded

721

W

Depot Inventory by Unit UNBLINDED report

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Site Inventory by Unit Unblinded

728

W

Site Inventory by Unit UNBLINDED report

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Drug Accountability Overview

710

W

Drug Accountability Overview report

Sponsor Users

Detailed Drug Reconciliation

715

W

Detailed Drug Reconciliation report

Sponsor Users

Projected Supply Usage

723

W

Projected Supply Usage report

UNBLINDED USERS ONLY (Unblinded Drug Supplies Manager)

Users

User Contact Information

711

W

User Contact Information report

Site Users

Sponsor Users

System Access

712

W

System Access report

Sponsor Users

Ad Hoc

Create Custom Report

798

W

Create Custom Report reports

Depends on report

View/Manage Custom Reports

799

W

View/Manage Custom reports

Depends on report

Approvals

Subject Approvals

309

W

Subject Approvals report

Oracle Administrator

Sponsor users

Configurations (for internal use only)

General Configuration

801

W

General Configuration page

Oracle Administrator

Sponsor users

Transaction Configuration

802

W

Transaction Configuration page

Oracle Administrator

Sponsor users

Manage Permissions

803

W

Manage Permissions page

Oracle Administrator

Sponsor users

Manage Roles

804

W

Manage Roles page

Oracle Administrator

Sponsor users

Manage Visit Schedule

805

W

Manage Visit Schedule page

Oracle Administrator

Sponsor users

Manage Notification Delivery

806

W

Manage Notification Delivery page

Oracle Administrator

Study Manager

Admin

View AppBlock Logs

901

W

View AppBlock Logs page

Oracle Administrator

View Diagnostic Logs

914

W

View Diagnostic Logs page

Oracle Administrator

Notification Subscriptions

909

W

Notification Subscriptions page

Oracle Administrator

Study Configuration Variables

919

W

Manage Inform Setup page

Oracle Administrator

Verify Configuration

911

W

Verify Configuration page

Oracle Administrator

Run Scheduled Task

912

W

Run Scheduled Task page

Oracle Administrator

Audit History View

915

W

Audit History View page

Oracle Administrator

Manage Custom Page Menus

913

W

Manage Custom Page Menus page

Oracle Administrator

Other Permissions

Subject_EditSubjectData

208

W

Edit Subject Data on Transactions Configurations page

Sponsor Users

Subject_MissedVisit

209

W

Missed visit tasks on the Subject Transactions page

Sponsor Users

Subject_AgeApproval

214

W

Out-of-age approval tasks on the Subject Approvals page

Sponsor Users

Subject_MissedVisitApproval

218

W

Missed visit approval tasks on the Subject Approvals page

Sponsor Users

Subject_ViewFlag

290

W

Flag a subject as misrandomized or off-treatment on the Subject Transactions page

Sponsor Users

Drug_ManageDrugSupplyTypes_
ResupplySetting

651

W

Resupply Settings page

Sponsor Users

Drug_ManageDrugSupplyTypes_Edit

652

W

Edit the supply type on the Resupply Settings page

Sponsor Users

Reports_Home

700

W

Reports tab

Site Users

Sponsor Users

Ad Hoc Base Report - Dispensed Units

724

W

Dispensed Units on the Ad Hoc Report page

Sponsor Users

Ad Hoc Base Report - Subject Details

725

W

UNBLINDED subject details on the Ad Hoc Report page

Sponsor Users

Ad Hoc Base Report - Site Details

726

W

Site Details on the Ad Hoc Report page

Sponsor Users

Ad Hoc Base Report - Depot Details

727

W

Depot Details on the Ad Hoc Report page

Sponsor Users

Admin_AssociateYourSelfWithASite

907

W

Associate your role with a site for testing purposes

Oracle Administrator

Admin_ViewReleaseNumber

916

W

Release number information

Oracle Administrator

Admin_AppBlockValidation

950

W

View AppBlock Logs page

Oracle Administrator

Admin_AppBlockAccess

951

W

View AppBlock Logs page

Oracle Administrator

Dashboard - Subject Task List

1300

W

Subject Task List on Home page

Site Users

Sponsor Users

Dashboard - Drug Order Task List

1301

W

Drug Order Task List on Home page

Site Users

Sponsor Users

Dashboard - Depot Task List

1302

W

Depot Task List on Home page

UNBLINDED users only

Dashboard - Enrollment Summary

1303

W

Enrollment Summary graph on Home page

Site Users

Sponsor Users

Dashboard - Depot Inventory

1304

W

Depot Inventory graph on Home page

UNBLINDED users only