What are the requirements for a screening visit?

In general, screening visits are optional. However, if your study is configured to assign subject numbers during screening, it is mandatory to include a Screening visit as the first visit in the visit schedule. This way you ensure accurate subject screening and proper study progression.

There are rollover or enrollment (registration) studies where subjects are screened in an external system and don't require you to create a screening visit in Oracle Clinical One Platform at all, unless those subjects need to be re-screened.

On the other hand, there are other studies where the screening visit is included and mandatory. In some of them, the screening visit is the first scheduled visit and in these cases it is fine to assign subject number during screening. In some other studies, a screening visit might be included but may not be the first required visit. These studies should be configured to assign subject numbers as soon as the subject is added in Oracle Clinical One Platform, that way screening can occur after enrollment (or any other initial visit in the schedule).

For studies where the subject number is assigned when a subject is screened, there are additional requirements that you should consider when designing your screening visit and forms.

Design requirements for subject number assignment at screening

For studies where subject numbers are assigned during the screening visit, work with your study manager to ensure alignment between the site workflow and the forms and data collected during the screening visit:
  • You must create a required screening visit as the first visit in the schedule. This means you cannot include a pre-screening visit in your visit schedule.

    WARNING:

    Otherwise, the study manager cannot configure the Assign Subject Number setting to When subject is screened. See Specify study settings.
  • You should not mark questions or items on screening visit forms as Required for Screening, Required for Randomization, or Required for Dispensation. All required fields must be completed by a site user for the subject's screening to be successful.
  • Exclude these form elements from screening visit forms:
    • Lab and two-section forms
    • Repeating forms
    • Form associations (you can configure them, but site users can only link forms after screening the subject and assigning a subject number)
    • Age questions (unless you design them as optional)
    • File upload questions
    • Required fields populated by custom JavaScript rules (you and your rule designer should work to ensure that no required fields in the screening visit are filled in by custom calculation rules)
    • Required hidden questions (optional hidden questions can be included)

Related Topics

Parent topic: Visits and schedules