Purpose

Understand the transition from screening to randomized assignment and why eligible site supply matters.

Expected outcome

You can identify the required study/site context, distinguish screening from allocation, and interpret supply-related allocation failures.

Prerequisites

Correct Account/study and an active permitted site. Screening requires Subjects.Manage; randomization requires Subjects.Randomize, an eligible screened subject and configured design.

Section 1: Screen a subject

  1. Open Subjects and choose Screen subject when authorized.
  2. Select the active site.
  3. Enter the permitted subject number or allow automatic assignment. Avoid direct personal identifiers.
  4. Enter protocol-required measurements. The screening form supports optional weight 1-500 kg and height 30-250 cm.
  5. Submit once and read the explicit result. Open the created record to review it.

Section 2: Randomize with eligibility and strata

  1. Open the screened subject.
  2. Provide each configured stratification factor and select an open cohort if applicable.
  3. Confirm that inclusion/exclusion requirements have been assessed under the approved protocol.
  4. Submit Randomize subject and verify the resulting status and recorded assignment.

A checkbox does not replace documented clinical assessment.

Section 3: Site-stocked block behavior

For the applicable block-aware workflow, a new subject can be allocated using eligible kits within an available site block. Revisits prefer a different compatible block. When another block is not available, eligible stock matching the required treatment can provide the supported fallback.

Allocation is not unrestricted selection of any stock: product, treatment, master-ID and stock-state rules still apply.

Troubleshooting and checks

Check study status, strata, cohort capacity, site scope and eligible inventory before retrying a failed allocation. Blinded users must not inspect arm labels to diagnose stock. Never create an off-system assignment to bypass a shortage or lock.

Captured Subjects list with record values redacted and filter headings visible
Captured application view · redactedThe Subjects grid and its filters are captured from the application. Subject identifiers, dates, assignments and other record values are redacted. Click the image to enlarge it.

Related articles

Study design and randomization Master randomization, previews and exports Visit products and two-arm crossover

This guide supports training and does not authorize clinical decisions, override access controls or establish regulatory compliance. The approved protocol and organizational procedures remain authoritative.