Workflow to configure subject number assignment after screening

This workflow outlines the steps for configuring a study to assign subject numbers after the screening process.

For more information about the differences between assigning subject numbers upon addition and after screening, see Understand how subject number assignment impacts a study.

1. The study designer adds and configures the Screening visit

To assign subject numbers after screening, the study schedule must include a screening visit. The study designer should create the required screening visit and forms for the study. They must ensure that the screening visit is the very first visit in the schedule and that it is required.

The screening forms must follow specific design requirements. For more information, see What are the requirements for a screening visit? and Create a visit or event.

Tip:

Run the Study Design report and verify that the design aligns with the protocol.

2. The study manager determines how subject numbers are assigned

The study manager must configure the study's settings to assign subject numbers based on the study's requirements. In this case, they must set the Assign Subject Number setting to When subject is screened and adjust other subject management settings as needed. For more information, see Specify study settings.

For studies where subject numbers are assigned after screening, enrollment limits reached at either the study, country or site level, block site users from screening candidate subjects. In either case, the Screen Candidate button is disabled and a tooltip displays to inform users about the closed enrollment. See Understand how subject number assignment impacts a study.

Tip:

Run the Study Settings Report and verify the setting configurations.

3. Site users begin screening candidates

Once the study's design and settings are tested and approved, site staff can begin screening candidates. They must ensure all necessary data is collected and, if prompted, manually assign subject numbers after submitting the screening forms. For more information, see Start with screening a candidate.