Oracle Clinical One Platform to Oracle InForm

Configuration service details for this integration

B92665: Oracle Health 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.

Reach out to your Oracle point of contact if more information is needed.

Integration details

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 below.

Subject event data

Type of data	Notes
Clear a visit date	By default, the visit date is cleared in Oracle InForm as long as the Oracle Central Designer Date Time Properties for the visit date item are configured correctly. In Oracle Central Designer, ensure the Required option is disabled for all date and time components under the Date Time Component Setting section. WARNING: The integration does not verify the setting. If the date and time components are enabled, the integration fails, and the update is not posted to InForm. The integration template can be updated if you do not want to integrate clear visit date events.
Screen a subject	You choose the data to send.
Screen fail a subject and undo screen failure	For screen failure, the screen failure user-entered date and reason along with any other relevant information related to the screen failure event are sent to Oracle InForm. 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 undo 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.
Update a form for a subject	You choose the data to send.
Complete a subject's visit	You choose the data to send.
Transfer a subject	You choose the data to send.
Withdraw a subject and undo withdrawal 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 subject withdrawal, the withdrawal form in Oracle InForm is updated with the withdrawal date and reason, as well as any other relevant information. For undo subject withdrawal, the completion date and other details that were sent are cleared out in Oracle InForm. Oracle Clinical One Platform retains the information in the withdrawal form.
Complete a study for a subject and undo study completion 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 study completion, the completion date and any other relevant information for a subject completion event is sent to Oracle InForm. For undo study complete, the completion date and other details that were sent are cleared out in Oracle InForm. The information in the study completion form in Oracle Clinical One Platform remains.

Kit event data

Type of data	Notes
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 visit form. The new information includes dispensation date, original kit number and new kit number, amongst others.
Re-dispense a conserved kit	The conserved kit number and any other relevant data can be sent to Oracle InForm and included in a visit form.

Form data

Type of data	Notes
Apply, update, or clear a data flag	In Oracle InForm, data flags correspond to the Reason Incomplete options available in the user interface for incomplete form answers. In Oracle InForm the Data Entry Flag is collected in the item comment section. Clicking the Comments icon 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 N/A, Unknown, or Not Done) in Oracle InForm is set to No. The Display Comment Text Boxes setting is set to Yes.

Type of data

Notes

Apply, update, or clear a data flag

In Oracle InForm, data flags correspond to the Reason Incomplete options available in the user interface for incomplete form answers. In Oracle InForm the Data Entry Flag is collected in the item comment section. Clicking the Comments icon 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 N/A, Unknown, or Not Done) in Oracle InForm is set to No.
The Display Comment Text Boxes setting is set to Yes.