Contents

INTRODUCTION Getting started What is IRT? Users, roles, and permissions Getting authenticated The authentication process User ID, password, and confidentiality IRT strong password requirements Signing the User Authentication Form (UAF) User activation Authenticating your user account Accessing IRT Logging in and out Changing and resetting your password Unlocking your account Phone access Logging in using the phone Processing transactions over the phone A user interface walkthrough Standard vs. study-specific content Application page Home dashboard Forms Sorting and filtering data in a form Filtering data in a form Applying status filters Custom filters Logical operators for custom filters Conditions for custom filters Creating a custom filter Building the custom filter Accessing documentation Getting online help Opening study-specific documentation Getting notifications Email notifications Delivery of alerts, notifications, and email attachments Sending non-sensitive notifications as text Viewing and editing your contact information SITE TASKS Logging subject visits Roadmap: Subject visits Guidelines: Subject transactions Screening the subject The screening visit The screening process Screening a new subject Checking the date of the next visit Screen failures (after screening) Screen failing a subject Alternatives to screen failure Requesting an out-of-age approval Randomizing the subject The randomization visit The randomization process Randomizing a subject Completing the visit schedule Regularly scheduled visits The visit process Logging a scheduled visit Marking a visit as missed Visits scheduled for a future date Logging a future date visit Rescheduled visits Logging an out-of-window visit request Subjects who are removed from the study Early terminating a subject Problems with drug supplies Replacing missing or damaged supplies for a subject Registering subject completion The final visit The process of subject completion Logging a subject completion Correcting subject information The process of correcting subject information Correcting visit information Subject data edits Editing subject data Drug reallocation Reallocating drugs Flagging subjects Subject flags described Off-treatment subjects Flagging a subject as off-treatment Mis-randomized subjects Flagging a subject as mis-randomized Removing a subject flag Rolling back a visit Visit rollbacks Guidelines: Visit rollbacks Requesting a visit rollback Other visit schedule issues Subject transfers Transferring a subject to another site Checking approval status (requester) Managing unblinding Unblinding a subject Registering order receipt Registering the receipt of a complete, undamaged supply order Registering the receipt of entire supply orders that are incomplete, damaged, or involved in temperature excursion Registering receipt of specific drug units that are incomplete or damaged DRUG SUPPLY TASKS Managing drug supplies Roadmap: Depot setup and drug release Decide on a depot architecture Types of facilities Flowchart: Common depot architecture About the depot architecture example Releasing drugs to IRT The drug release process The components of drug release Setting up depots The depot setup process Creating a depot Adding local depots to a central depot Setting up a drug destruction facility (DDF) Editing depot information Associating drug units with depots Depot association of non-serialized vs. serialized drug units Associating serialized drug units with depots Dissociating serialized drug units from depots Adding or subtracting non-serialized drug units for depots Setting up lots Lots and expiry described Adding a lot Editing lot information Deleting a lot Suspending a lot Associating drug units with lots Lot association of non-serialized vs. serialized drug units Associating serialized drug units with lots Dissociating serialized drug units from lots Adding or subtracting non-serialized drug units for lots Setting up label groups Label groups described Adding a new label group Editing a label group Deleting a label group Associating drug units with label groups Associating serialized drug units with label groups Dissociating serialized drug units from label groups Adding or subtracting non-serialized drug units for label groups Applying a new expiration date Over-labeling of unused drug units Applying a new expiration date to an entire lot Applying a new expiration date to specific drug units Set up manufacturing lots Adding a manufacturing lot Drug supply management Roadmap: Resupply management Automating drug supply at sites Resupply configuration described Flowchart: Resupply configuration Definitions of resupply configuration settings Adding a new supply type Editing a supply type Deleting a supply type Automating supplies with the Smart System module Smart System module described Switching on the Smart System module Defining Smart System settings Managing drug orders Registering the receipt of a complete, undamaged supply order Registering the receipt of entire supply orders that are incomplete, damaged, or involved in temperature excursion Registering receipt of specific drug units that are incomplete or damaged Canceling a supply order The order cancelation process (One role) Canceling a supply order (Two roles) Canceling a supply order Verifying shipment of a supply order Requesting a manual order by quantity Requesting a manual order by sequence range Updating inventory The process of updating inventory User-applied drug unit statuses Applying a new drug status at a site Applying a new drug status at a depot Updating the site inventory Updating the depot inventory Managing drug accountability Roadmap: Drug accountability The drug reconciliation process Reconciling inventory (Site user) Entering drug reconciliation details at the site (Field monitor) Entering drug reconciliation details at the site Destroying excess drug The drug destruction process (Field monitor) Preparing drug reconciliation units for shipment or destruction (Site user) Preparing drug reconciliation units for shipment or destruction Confirming supply destruction Entering drug reconciliation details at the DDF Reconciling discrepancies SPONSOR TASKS Reviewing requests for approval Roadmap: Subject approvals People involved in subject approvals The approvals process Transactions that could require approval Levels of approval Guidelines: Requests for approval Viewing completed requests Checking the status of an approval request Approving or rejecting requests assigned to you Managing the study Roadmap: Study set up and user management Approving drug and randomization schedules The process of approving the drug and randomization schedules Approving the randomization schedule Exporting the randomization schedule Approving the drug schedule Exporting the drug schedule Setting up screening and randomization limits and statuses The process of setting up screening and randomization limits and statuses Setting overall screening and randomization limits Opening and closing screening and randomization for a study, region, or country Adding and managing countries and regions The process of adding and managing countries and regions Adding a new country Adding a new region Editing a country Deleting a country Editing a region Deleting a region Adding and managing users The process of adding and managing users Uploading users Adding users to the study Correcting errors after user upload Managing users Editing a user�s contact information, role, and site or depot association Resetting a user�s password Locking and unlocking a user Deactivating and reactivating a user Linking a user to sites or depots Pending users Retransmitting and editing user activation data Disabling and enabling user activation Subscribing notifications to a role Managing the site Roadmap: Adding and managing sites Uploading sites The process of uploading sites Uploading multiple sites to the study Correcting errors after a site upload Adding a single site to a study Activating and setting up sites The process of activating and setting up a site Setting a site supply type Activating and deactivating a site Opening and closing screening, randomization, and drug ordering at a site Setting a site screening and randomization limit Managing sites Editing site information Suspending automatic drug ordering Working with reports Working with standard reports Viewing a standard report Exporting a standard report Subject reports Subject Details Subject Details Sponsor Visit Summary Randomization Report Unblinded Edit Subject Data Drug Reallocation Drug Reallocation Unblinded Visit Rollback Report Study reports Enrollment Summary Overall Summaries Site Overall & Monthly report Site Statistics Audit Site Supplies reports Order Summary Site Inventory Site Inventory Unblinded Depot Inventory Depot Inventory Unblinded Depot Inventory by Unit Unblinded Site Inventory by Unit Unblinded Drug Accountability Overview Detailed Drug Reconciliation Projected Supply Usage Users reports User Contact Information System Access Working with ad hoc reports Creating a custom report Saving a custom report Save Current Report dialog box Editing a custom report Viewing a custom report APPENDIX Drug unit statuses User-applied drug unit statuses System-applied drug unit statuses Page descriptions Home: Page descriptions Home tab Contact Information page Notifications page Subjects: Page descriptions Subjects tab Subject Transactions page The visit schedule Screening page Randomization page Scheduled Visit page Early Termination page Subject Completion page Subject Visit Details page Out of Window / Missed Visit Approval Request page Drug Replacement page Flag Subject page Subject Transfer page Supplies: Page descriptions Supplies tab Depots page Depot Association page Lots & Expiry page Manufacturing Lots page Lot Association page Label Groups page Label Group Association page Resupply Setting page Smart System page Inventory Management page Update Site Inventory page Update Depot Inventory page Order Transactions page Request Manual page Reconciliation by Site and Monitor page Ready for Shipment or Destruction page Reconciliation by Return Depot page Study menu: Page descriptions Study tab Study Limits page Randomization Schedule page Drug Schedule page Roles Notifications page Manage Countries page Manage Regions page Edit User page Link to Site/Depot page User Upload page Pending Users page Site menu: Page descriptions Site tab Manage Sites page Site Upload page Approvals: Page descriptions Subject Approvals page