Table of Contents
- Title and Copyright Information
- Preface
- 1 I'm a new user. Where do I start?
- 2 Before you configure a study
-
3
Create and manage your
organization's library
- About library studies
- Copy a library study
- Create and design a library study
-
Create and manage code
lists
- About your code list library
- Understand the prerequisites for importing a code list
- Create a system code list group for all studies
- Create and use study company filters
- Create a custom code list
- Import a custom code list
- Assign a system code list group to your study
- Manage a code list for all or one study
- Browse the list of system default code lists
-
Create and manage library
objects
- About pooling kits in a study
- Create and edit a form object
- Create and edit a kit object
- Edit a form object's attributes
- Edit a kit's object attributes
- Leave and manage comments
- Import a form object
- Version a form object
- Test and approve an object
- Publish an object in a library
- Add an object to a live study
- Test an object in a live study
-
Create and manage institutions,
vendors, and contacts
- Understand site, depot, and lab management
- Create an organization (institution)
- Create a vendor (depot)
- Create a vendor (lab)
- Create a contact at your organization
- Specify a reusable address for your organization and contacts
- Set up a site at the global level
- Edit a contact's details
- Edit an organization's details
- Manage associations for a contact
- Update the status of a contact
- Deactivate a contact and transfer studies
- Delete a contact
- Delete an organization
- Retire a site at a global level
- Retire a depot at a global level
- Retire a lab at a global level
- Transfer active organizations
- Transfer active contacts
-
4
Configure a study
- Make a study version available
-
Set up facilities
- Add a depot for a study
- Edit a depot at a study level
- Delete a depot at a study level
- Add a site to a study
- Edit a site at the study level
- Delete a site at the study level
- Add a lab to a study
- Define lab normals
- How are lab normal updates reflected in existing lab forms?
- Assign a local lab to a site
- Make sure users are assigned to the correct sites and depots
-
Define settings
- Add a locally sourced kit
- Add a region
- Specify study, enrollment, and visits settings
- Specify enrollment settings for minimization cohorts
- Manage screening and randomization limits by site
- Create or edit custom enrollment limits
- Understand source data verification
- Specify settings for Source Data Verification
- Create a source data verification strategy and assign it to a site
- Specify supply settings
- Understand how dose holds work
- Create or edit a dose hold
- Create and manage a partial dispensation
- Create a min/max resupply strategy
- Create a predictive resupply strategy
- Create a blinded group of kits
- About signature configurations
- Create a signature configuration
- Manage signature configurations at the casebook level
- Configure the connection to Oracle mHealth Connector so you can dispense devices
-
Manage randomization
- Generate a randomization list
- About the randomization list duplicate
- 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
- Make a study live
- Verify a study in Testing mode
- Create and manage custom rules
- Manage dispensation exceptions
-
5
Work during the study conduct period
- 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
- View a drug order form
- 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
- Receive a shipment with disabled temperature excursions
- 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 the site and study
level
- Access the Study Inventory tab
- Access the Site Inventory tab
- Access the Depot Inventory tab
- Filter kits in a Study's Inventory tab
- Filter kits in a site's inventory
- Search and filter kits on the Depot Inventory tab
- Manage non-serialized inventory
- Add non-serialized kits to a lot
- 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
- Available inventory statuses for kits
- Allowed updates for inventory status
- What if a site user dispensed a kit in error?
- View and update randomization numbers
-
Monitor subjects and sites
- Find incomplete visits
- Lock a subject at the form or visit level
- Unlock a subject at the form or visit level
- Lock a subject at the casebook level
- Unlock a subject at the casebook level
- 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
- Review the data collected for a subject
- Verify a subject's data
- About Source Data Verification statuses
- Transfer a subject
- Verify that a site received a shipment
- What if a site user randomized a subject in error?
-
Create and manage queries
- About the Query List
- Understand query statuses
- Access the Query List
- Filter the Query List
- Explore a query's details and history
- Work in the Query List
- View and monitor queries
- Create a query
- Lock a question or query
- Unlock a question or query
- Open or delete a candidate query
- Review a query, and either close or re-open it
- Perform kit reconciliation
- Run and download a report, data extract, or archive
- 6 Archive a study version, decommission and recommission a study
-
7
In-product training
- Track training and send training reminders
- Turn off the training requirement for an organization
- Practice data entry in Training mode
- 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
- 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 are the required kits calculated in a predictive resupply strategy?
- 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?
- 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?
-
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?
- How are subjects randomly selected for targeted source data verification?
- How do changes in Source Data Verification settings impact on a study?
- 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 is my workflow for setting up a rollover study?
- Update study settings during the study conduct period
-
Subject and data entry FAQs
- About clearing dynamic questions
- 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?
- How does clearing data may impact my study?
- Workflow for updating a subject number during the study conduct period
- 9 Revision history