Enter data in the next visit before current visit completion

You can now allow site users to move on to the next visit and enter data that is already available, without completing the current visit's full data collection.

Study designers can now mark visits with the new setting Allow Next Visit Without Completion which allows site users to move on to the next visit and enter data if already available. This is useful as sometimes data for the next visit becomes available prior completing the current visit; whether it is that the whole current visit data is not immediately available or may take significant time to enter into the system. With this, Clinical One Cloud Service provides flexibility to enter data when it is available, while still maintaining the indication that there is required data that needs to be provided on earlier visits for completion.

You can enable this new setting for scheduled required visits, as well as Rescreening, and Screen Failure visits. Optional visits have this setting grayed out, which gets enabled for selection only after the visit is marked as required. Other unscheduled events, such as Withdrawal, Completion and Adverse Events, do not show this setting at all.

The following criteria must be met for the next visit to display, even if the current visit is in progress or incomplete:

• The current visit is set to Allow Next Visit Without Completion as per design.
• At least one question for the visit is answered. It can be the visit date.
• All applicable Randomization and Trial Supply Management (RTSM) actions have occurred.

  Tip:

  To guarantee this, make sure you use this feature in combination with the toggles that define questions required for specific RTSM actions:

  • Required for Screening
  • Required for Randomization
  • Required for Dispensation

  For more information see Specify RTSM actions that require complete answers.
• Any dynamic parent question for forms, visits or branches have been answered.
• There is a next visit to show, either a static visit or a triggered dynamic visit or branch.

You can find additional information in the Study Designer User Guide after the assessment environment upgrade.

Impact on reports

The following table describes this feature's impact to reports:

Report	Description
Study Design report	Updated to include the new visit level design setting Allow Next Visit Without Completion. This information is added in the Visit section, under the existing Visit Schedule column, with the following possible values: Yes No N/A ( This is for optional visits or visits where this is not applicable)
Annotated Case Report Forms	Updated to include the new visit level design setting Allow Next Visit Without Completion. This information is added in the Forms by Visit section for each visit on its own row (under Visit Date SDV), and has the following possible values: Yes No N/A ( This is for optional visits or visits where this is not applicable)
ODM-XML extracts	The following new attribute is added as a Clinical One extension to the ODM metadata extract: co:NextVisitWithoutCompletion

You can find additional information about reports in the Reporting Guide after the assessment environment upgrade.

For more information about the impact on Oracle Clinical One Analytics, ODM Extracts, and other applications, see Release impact on downstream applications.

Already working in a live study?

As soon as this release is available you can start using this new feature. To apply this change, you only need to configure it in the study version design, and it will apply irrespective of the version status (whether it is in the Testing or Approved container).

If a visit is inserted using the Future & Past option in Draft mode and is scheduled as the next visit of a visit configured with this new setting, the new visit will be added in the Next Visit column and available for data entry. This is only considering all criteria for displaying the next visit have been met.