Table of Contents

• Title and Copyright Information
• Preface
  • Documentation accessibility
  • Related resources
  • Access to Oracle Support
  • Additional copyright information
• 1 I'm a new user. Where do I start?
  • Get sign-in information
  • Get trained as you work
• 2 Design a study
• 3 Get ready for Testing mode
  • Set up facilities
    • Add a depot
    • Add a site
    • Create a local lab
    • Define lab normals
    • Assign a laboratory to a site
    • Make sure users are assigned to the correct sites and depots
  • Define settings
    • Add a region
    • Specify study, enrollment, and visits settings
    • Specify enrollment settings for minimization cohorts
    • Create or edit custom enrollment limits
    • Specify supply settings
      • Supply settings fields
    • Understand how dose holds work
    • Create or edit a dose hold
    • Create a min/max resupply strategy
    • Create a predictive resupply strategy
    • Create a blinded group of kits
    • Specify settings for a source data verification strategy
    • Create a source data verification strategy and assign it to a site
    • Configure the connection to Oracle mHealth Connector so you can dispense devices
  • Manage randomization
    • Generate or upload a randomization list
    • Understand the concepts used in minimization
    • Upload a randomization list for minimization
    • Assign blocks of randomization numbers to a site, country, or region
    • Assign a randomization list to a randomization design and study version
  • Manage supplies
    • Generate or upload a kit list
    • Deactivate a kit list in Testing mode
    • About manufacturing and blinded lots
    • Manage expiration dates with lots
    • Assign kits to a manufacturing lot
    • Combine manufacturing lots into a blinded lot
    • Create label groups
    • Release kits to sites or depots
    • Specify and review settings before verifying a study
  • Make a study live in Testing mode
    • Assign a study version to a site
    • Select a resupply strategy for a site
    • Assign a resupply strategy to a depot
    • Open and close a cohort
    • Activate a site
    • Activate a depot
  • Create and manage custom rules
    • Access the rules interface
    • Create a rule for a calculated value
    • Create a rule for an automated query
    • Create a rule to send an email notification
    • Debug a rule
    • Prepare your rule for testing and approval
    • Test and approve a rule
    • Publish a single rule
    • Publish multiple rules at the form level
    • Publish multiple rules at the study level
    • Modify and republish a published rule
    • Rule status descriptions
    • What types of JavaScript expressions can I use to create a rule?
  • Verify a study
    • Verify a study
    • What if I have problems trying to verify a study?
    • View a subject's randomization number in a study you're verifying
• 4 Get ready for Production mode
  • Specify study settings
    • Make a study version available
    • Specify subject, visit, limit, and cohort settings
    • Specify supply settings
    • Create a min/max resupply strategy
    • Create a predictive resupply strategy
    • Create a blinded group of kits
    • Specify settings for a source data verification strategy
    • Create a source data verification strategy and assign it to a site
  • Manage randomization
    • Generate or upload a randomization list
    • Assign blocks of randomization numbers to a site, country, or region
    • Assign a randomization list to a randomization design and study version
  • Manage supplies
    • Generate or upload a kit list
    • Deactivate a kit list in Production mode
    • Manage expiration dates with lots
    • Assign kits to a manufacturing lot
    • Combine manufacturing lots into a blinded lot
    • Create label groups
  • Make a study live in Production mode
    • Assign a resupply strategy to a depot
    • Activate a depot
    • Release kits to depots
    • Assign a study version to a site
    • Select a resupply strategy for a site
    • Open and close a cohort
    • Activate a site and make a study live
    • What if users have problems working in a live study?
      • Open a production study
    • Practice data entry in Training mode
• 5 Work during the study conduct period
  • Access the Study Inventory tab
  • Access the Site Inventory tab
  • Filter kits in a site's inventory
  • Filter kits in a study's inventory
  • Use the study dashboard to get easy access to data
  • Manage shipments
    • View the shipments sent to sites
    • Add and remove kits in a shipment
    • Create a manual shipment
    • Specify a ship date and tracking number for a shipment
    • Mark a shipment as lost
    • Cancel a shipment
    • Check whether a shipment was marked invalid
    • Disallow temperature excursions for shipments
    • Quarantine a shipment with temperature excursions
    • Quarantine shipments set to Quarantine with no temperature monitor
    • Move shipments through the receipt process with no temperature monitors
    • Release kits or shipments from quarantine
  • Manage kits at a site
    • Monitor site and depot stock levels
    • Transfer the product to another location
    • Mark kits to test for temperature excursions
    • Quarantine kits
    • Mark a kit as missing or damaged
    • Reserve kits for a quality check
    • Update the status of a kit for a site user
    • Update a kit's barcode
    • What if a site user dispensed a kit in error?
  • View and update randomization numbers
    • View a subject's randomization number
    • Manually assign a randomization number to a subject
    • Mark randomization numbers that were used in error
  • Monitor subjects and sites
    • Find incomplete visits
    • Freeze and unfreeze data
    • Filter subjects in a study
    • Manage site permissions
    • Verify that a site has been activated
    • Reveal a subject's treatment arm
    • Re-verify a subject's data
    • Review the data collected for a subject
    • Verify a subject's data at a form and question level
    • Transfer a subject
    • Verify that a site received a shipment
    • What if a site user randomized a subject in error?
  • Create and manage queries
    • View and monitor queries
    • Create a query
    • Open or delete a candidate query
    • Review a query, and either close or re-open it
  • Perform kit reconciliation
    • Verify returned kits to confirm and correct site reconciliation
    • Mark kits as ready for destruction at the site or at a depot
    • Ship kits to a drug destruction depot
    • Mark kits as destroyed
    • What if a site user can't see the Returned Units and Missing Units fields?
  • Archive a study version and decommission a study
    • Close enrollment for a country or study
    • Archive a study version
    • Delete a study
    • Revoke a user's access to the study
    • Retire a depot
    • Retire a site
    • Decommission a study
    • Recommission a study
• 6 Update a study's design during the study conduct period
  • Create a new Draft version of a study to update the Approved version
  • Add a new form to a live study version
  • Update a form during the study conduct period
  • Set up a visit that must be inserted into the schedule of a live study version
    • About inserting a visit
    • Insert a visit
  • Add a dynamic visit in the schedule of a live study
  • Drop a treatment arm, add cohorts, or update randomization during the study conduct period
  • Extend the treatment period for subjects during the study conduct period
  • Update a kit type during the study conduct period
  • Update the way that subjects titrate during the study conduct period
  • Update study settings during the study conduct period
  • Update a randomization list that ran out of numbers during the study conduct period
  • Update a kit list that ran out of numbers during the study conduct period
  • Update the study version that is assigned to a site
  • Archive an Approved version of a study
• 7 In-product training
  • Track training and send training reminders
  • Turn off the training requirement for an organization
  • Can I watch the training videos without signing in to Oracle Clinical One Platform?
  • Will I have to retake training after a system update?
  • I work in multiple studies. Do I have to take training in every study?
• 8 Reference information
  • Run and download a report, data extract, or archive
  • Receive notifications
  • Troubleshoot
    • A site user receives a message that a subject's age couldn't be calculated
    • I need to correct a multiple choice question in a live form
    • I published a rule by mistake
    • I step away and then can't work in Oracle Clinical One Platform anymore
    • More troubleshooting help
  • Frequently Asked Questions (FAQs)
    • Integration FAQs
      • Which products can Oracle Clinical One Platform integrate with?
      • How do I set up an integration?
      • Which data can be shared with Oracle InForm?
      • Which data can be shared with a third-party electronic data capture system?
      • What is the workflow for shipments when I use an integration?
        • Workflow for an integration with Almac Global Depot Network
        • Workflow for an integration with Catalent Clinical Supply Services
        • Workflow for an integration with Fisher Clinical Services
    • Inventory management and dispensation FAQs (for clinical supply managers)
      • What if a site anticipates an enrollment surge?
      • How often should I run inventory?
      • What levels of the supply chain can I manage in Oracle Clinical One Platform?
      • Which resupply strategy should I use?
      • Do I need to monitor product levels at sites?
      • How do I manage expiration dates and replenish stock to prepare for imminent expiration dates?
      • How do I manage temperature excursions for kits and shipments?
      • How do I set the expiration dates for kits?
      • How does Oracle Clinical One Platform determine the kits that are selected for shipment or distribution to subjects?
      • Are all kits at a site counted in inventory?
      • What if a subject loses or damages a kit?
      • Can I track a kit from manufacturer to depot to site to subject?
      • Can I change the contents of an automatic shipment?
      • Understand kit conservation
      • What is the workflow for shipments?
      • How do depots find out when a shipment is needed?
      • What can I do to prevent my shipments from revealing unblinding information to site users?
      • When should I send initial shipments to sites?
      • What if a depot has insufficient stock to resupply a site?
      • Can depots ship different kit types?
      • What if a site doesn't mark a shipment as received?
      • What do I do if a shipment is lost?
      • What is my workflow for enabling confirmation of dispensed kits?
      • Why are barcodes useful in a study?
      • Define kit dispensation logic
    • Kit reconciliation FAQs
      • Who is responsible for each step in the kit reconciliation process?
      • How do I turn on kit reconciliation?
      • Can I modify a Pending Destruction shipment?
      • What statuses can kits have?
      • What is the workflow for destroying shipments at a depot facility?
    • Query FAQs
      • How can I tell when a site has responded to a query?
      • Do I get notified when queries are created or responded to?
      • How do I get information about the age of queries?
      • What do I need to do before I can start using queries?
    • Randomization FAQs
      • How many times can I randomize in a study?
      • What randomization algorithms are available?
      • When I create a randomization design, what fields should I choose?
      • What are the rules for randomization designs?
      • If my randomization list is blocked by site, country, or region, how are blocks assigned?
      • How are subjects randomized when multiple cohorts are open?
      • What is my workflow for setting up a study with multiple periods?
      • What is my workflow for creating a study that uses cohorts?
      • Can I randomize subjects without dispensing kits to them?
      • Can I determine what happens when the next randomization number is associated with a code for a kit type that is not in stock at a site?
    • Randomization lists and kit lists FAQs
      • Guidelines for creating a kit or randomization list
      • Can I check that the randomization list or kit list generated by Oracle Clinical One Platform matches my requirements?
      • Can I test using a randomization list or kit list that Oracle Clinical One Platform generates and then upload a list from a statistician for a production study?
      • Can Oracle Clinical One Platform generate a kit list for my study?
      • Can Oracle Clinical One Platform generate a randomization list for my study?
      • How do I specify the size of the blocks in my randomization list to prevent unblinding?
      • How many randomization lists should I have for a study?
    • Rules expressions FAQs
      • What happens if my JavaScript expression does not return a value for a calculation?
      • What happens when one of the function's inputs (operands or variables) is cleared?
    • Rules management FAQs
      • What's the difference between a validation rule and a custom rule?
      • Can I publish a single rule in Production?
    • Site, depot, labs, and source data verification FAQs
      • About depot-to-depot shipments
      • I'm ready to go live. What do I need to do with sites?
      • Understanding source data verification settings
      • How are subjects randomly selected for targeted source data verification?
      • If a site is involved in more than one study, do I need to create multiple instances of the site?
      • If a depot is involved in more than one study, do I need to create multiple instances of the depot?
      • What is the workflow for creating and managing local labs?
    • Study version and rollover study FAQs
      • Can I work on and test two versions of a study at the same time?
      • I need to update my production study because of a revision or protocol amendment. What do I do?
      • Can I have multiple versions of a study in production?
      • How many different study versions can I have for a study?
      • How do I know which is the latest version of a study?
      • What changes can I apply to a form in a live study?
      • What is my workflow for designing a rollover study?
      • What is my workflow for setting up a rollover study?
    • Subject and data entry FAQs
      • What is the difference between an XPORT and CPORT file format?
      • What are my options for defining a subject's number format?
      • What happens if a site user enters invalid data?
      • What happens to coded terms when the answer to a coding question is cleared or updated?
      • Can a subject who screen failed be rescreened?
      • What does a site user do when a subject moves?
      • What happens if a site user doesn't answer a required question?
      • What time zone is subject data in?
      • What can't be done after a subject completes a study?
      • What states can a subject have?
      • What actions impact subjects?
      • What does each icon mean for signing, verifying, or freezing data?
• 9 Revision history