Create queries on the visit date

It is now possible to set up an automated validation of a visit's date against the visit window! Additionally, a visit's date can be selected to raise manual queries, as well as automated queries, and notifications through custom JavaScript rules.

Configure alerts for visit dates out of window

Study designers can now configure rules to alert a site user if a visit's date is outside of the visit window, either through a warning or by raising a query. When defining the visit schedule, there is a new field called Alert if Outside the Visit Window. This field displays the following options:

Off
Warning
Query

By default, the field is set to Off. This means it will not display any kind of alert, and all visits in current live studies will be set to Off, as well. Choosing to alert, either through a warning or a query, can help correct data entry errors and collect protocol deviation details to determine if the subject should remain in the study or if it should be included in the investigational product analysis at all.

As soon as this release is complete, you can start configuring these alerts. However, Advanced Study Versioning (ASV) is not supported, which means you need to make the change in a draft study version and move the updated study version to either Testing or Approved, and then apply that study version to the respective sites. Queries and warnings only display for visits added or updated after the Study Version change is applied.

You can find additional information in the Study Designer User Guide after the Release Assessment Environment (RAE) upgrade.

Raise manual queries on a visit's date

Previously, Clinical Research Associates (CRAs) and data managers would need to raise queries on the visit date targeting another question within one of the forms associated to the visit, which made it difficult to track and report. With this enhancement, CRAs and Data Managers can now raise queries directly on the visit date field. This helps streamline the data review processes,letting them associate queries to the correct question, document them properly, and generate clean reports with accurate information regarding these visit dates and their queries.

Raise queries on the visit date through custom rules

Besides the visit window validation, there may be other requirements related to visit dates that require custom rules, whether they're scheduled or unscheduled visits. The same way you can now raise manual queries on visit dates, rule developers can now select the visit date as the target for custom rules that raise automated queries and send notifications. The Add Rule function is now available when selecting the visit date field. Rules added to the visit date question have the following actions available:

Create Query
Create Assigned Query
Send Notification

Note:

The action option called Calculate Value is not available for visit date target rules.

You can find additional details on how to create different types of rules and the available rule helper functions in the Rules Developer Guide after the Release Assessment Environment (RAE) upgrade.