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