Oracle Clinical One Platform to Oracle InForm

Integrate study data from Oracle Clinical One Platform with Oracle InForm.

Configuration service details for this integration

B92665: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 70 Data Points.

Note:

For more information, see Oracle Life Sciences Cloud Consulting Professional Services, Service Descriptions and Metrics.

If you require more information, reach out to your Oracle point of contact.

Integration details

The following guidelines are required for a successful integration:
  • The site ID and site name must match in both systems.
    Sites for Oracle Clinical One Platform studies are created under Study Settings in the user interface. For Oracle InForm studies, sites are created in the Oracle InForm User Management Tool (UMT).

    Note:

    The integration does not integrate site details between the two systems. Sites must be created for each system as defined above.
  • All data on scheduled and unscheduled events (including unscheduled dispensation data) is sent to Oracle InForm at the intervals defined in the integration schedule. For more details on what types of data you can integrate, see the Subject event data section below.

Subject events and data

You can integrate data for the following subject events:
Subject event data Details
Clear a visit date

If you don't want to integrate clear visit date events, you can update the integration template.

Warning: The integration does not verify the setting. If the date and time components are enabled, the integration fails, and the update is sent to Oracle InForm.

  • By default, the visit date is cleared in Oracle InForm as long as the Date Time Properties for the visit date item are configured correctly in Oracle Central Designer.
  • In Oracle Central Designer, ensure the Required option is disabled for all date and time components under the Date Time Component Setting section.

Screen a subject

You choose the data to send from Oracle Clinical One Platform to Oracle InForm.

Oracle Clinical One Platform sends screening data to Oracle InForm based on one of two screening events.
  • Integrate data at visit complete: The screening visit is considered complete when a user answers all the required questions included in it. When this condition is met and the Screen button is selected, data is integrated.
  • Integrate data before visit complete: In this scenario, the screening visit does not need to be complete before data can be integrated. If a user answers all of the questions that are tagged as Required for Screening, the Screen button is enabled, and when selected, the data is integrated.

    For more information about this option, see Define required visits.

    Prerequisites to integrate data before visit complete.
    • You can integrate the visit start date with the screen event—not just with visit complete. The visit start date must be designed as a required question so the integration can uniquely identify cycles and unscheduled visits in the downstream system.
    • The study design must include the Informed Consent Date as a required question in order to integrate it with the screening event.
    • Integration template updates are required. Reach out to your Oracle point of contact for assistance.

Screen fail a subject, undo a subject's screen failure, or update a user's screen failure date and reason
  • For the screen failure event, the screen failure user-entered date and reason are sent to Oracle InForm, along with any other relevant information related to the screen failure event. You can map these fields to any form you use to collect the screen failure reason. The status for the subject in Oracle InForm isn't changed.
  • For undoing a subject's screen failure, the screen failure date is updated to blank in Oracle InForm. The status for the subject in Oracle InForm isn't changed.

Randomize a subject

You choose the data to send from Oracle Clinical One Platform to Oracle InForm.

Oracle Clinical One Platform sends randomization data to Oracle InForm based on one of two randomization events.
  • Integrate data at visit complete: The randomization visit is considered complete when a user answers all the required questions included in it. When this condition is met and the Randomize button is selected, data is integrated.
  • Integrate data before visit complete: In this scenario, the randomization visit does not need to be complete before data can be integrated. If a user answers all of the questions that are tagged as Required for Randomization, the Randomize button is enabled, and when selected, the data is integrated.

    For more information about this option, see Define required visits.

    Prerequisites to integrate data before visit complete.
    • You can integrate the visit start date with the randomize event—not just with visit complete. The visit start date must be designed as a required question so the integration can uniquely identify cycles and unscheduled visits in the downstream system.
    • Integration template updates are required. Reach out to your Oracle point of contact for assistance.

Update a form for a subject

You choose the data to send from Oracle Clinical One Platform to Oracle InForm.

Complete a subject's visit

You choose the data to send from Oracle Clinical One Platform to Oracle InForm.

Transfer a subject

You choose the data to send from Oracle Clinical One Platform to Oracle InForm.

Withdraw a subject, undo a subject's withdrawal, or update a subject's withdrawal date and reason

Note: Data related to these events can also be sent for subjects who failed screening. This is dependent on the study setting Screen Failed Subjects.

  • For the withdrawal event, the withdrawal user-entered date and reason are updated in the withdrawal form in Oracle InForm, as well as any other relevant information.
  • For the undo withdrawal event, the withdrawal date and other details that were initially sent are cleared out in Oracle InForm. Oracle Clinical One Platform retains the information in the withdrawal form. A subject's status in Oracle InForm is updated to Enrolled.
  • In the Oracle Clinical One Platform, if a user manually clears question fields in the resurfaced withdrawal visit, no job failures occur for this action. Jobs associated with the clear event should succeed in Oracle Clinical One Digital Gateway.
  • In the Oracle Clinical One Platform, if a user manually updates question fields in the resurfaced withdrawal visit, the updated values integrate into Oracle InForm without any jobs failing.

Complete a study for a subject, undo a subject's study completion, or update a subject's study completion date

Note: Data related to these events can also be sent for subjects who failed screening. This is dependent on the study setting Screen Failed Subjects.

  • For a subject's study completion event, the completion user-entered date and reason, as well as any other relevant information for a subject's completion event is sent to Oracle InForm.
  • For the undo study complete event, the completion date and other details that were sent are cleared out in Oracle InForm. Oracle Clinical One Platform retains the information in the completion form. A subject's status in Oracle InForm is updated to Enrolled.
  • In the Oracle Clinical One Platform, if a user manually clears question fields in the resurfaced completion visit, no job failures occur for this action. Jobs associated with the clear even should succeed in Oracle Clinical One Digital Gateway.
  • In the Oracle Clinical One Platform, if a user manually updates question fields in the resurfaced completion visit, the updated values integrate into Oracle InForm without any jobs failing.

Dispensation and kit data

Note:

Contact your Oracle point of contact if your study uses non-serialized kits and you would like to send data about non-serialized inventory to Oracle InForm.
You can integrate data for the following dispensation or kit-related events:
Type of data Details

Replace a kit that was damaged or lost

Data about replaced kits and new kits that are dispensed is sent to Oracle InForm and included in a form. The new information includes dispensation date, original kit number, and new kit number, along with other details.

Re-dispense a conserved kit

The conserved kit number and any other relevant data can be sent to Oracle InForm and included in a form.

Form data

You can integrate data for the following form-related events:
Type of data Details

Apply, update, or clear a data flag
Data flags correspond to the Reason Incomplete options available in Oracle InForm for incomplete form answers.
  • In Oracle InForm, the Data Entry Flag is collected in the item comment section. Selecting Comments in Oracle InForm displays the Reason Incomplete options equivalent to those in Oracle Clinical One Platform.
  • The Reason for Change from Oracle Clinical One Platform is featured on the Comment field above the Reason Incomplete options.
These are the default configurations in Oracle InForm. Make sure these settings are configured appropriately, so that data flag information can be sent from Oracle Clinical One Platform to Oracle InForm.
  • The Require a comment setting (when entering Not Applicable, Unknown, or Not Done) in Oracle InForm is set to No.
  • The Display Comment Text Boxes setting is set to Yes.

Parent topic: EDC Systems