Table of Contents
- Title and Copyright Information
- Preface
- 1 I'm a new user. Where do I start?
- 2 Design a study
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3
Get ready for Testing mode
- Set up facilities
-
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
- 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
-
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
-
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
-
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
- Manage supplies
-
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?
- Practice data entry in Training mode
-
Specify study settings
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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
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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
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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
- Perform kit reconciliation
- Archive a study version and decommission a study
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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
- 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
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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?
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8
Reference information
- Run and download a report, data extract, or archive
- Receive notifications
- Troubleshoot
-
Frequently Asked Questions (FAQs)
- Integration FAQs
-
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
- Query FAQs
-
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
- Rules management FAQs
-
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