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Subject phase composition

In clinical trials, a subject phase constitutes a pathway marking the progression of participants through various stages of the study. Each phase serves as a milestone that captures the subject's journey and is integral to the overall trial design and its scientific integrity. The structured progression through these phases ensures that the study adheres to the study protocol and recognized standards.

The Study Designer application provides tools to configure the subject phase flow. Study teams can craft and customize the flowchart, effectively plotting the course participants must navigate. This configuration is pivotal, as it not only outlines the operational conduct of the trial but also embeds regulatory compliance and ethical considerations into the trial's architecture. With an intuitive interface of Study Designer, study teams can establish clear transitions and ensure logical connection of phases.

For the hierarchical study design, where there is a master study and its substudies, you can add a transitional phase to forward the subject from the master study to the substudy. This gives you the flexibility for the scenario, for instance, when the subject is pre-evaluated in the master study, and if they qualify, they are allocated to the substudy screening.

Subject phase composition in Study Designer
Figure 1. Subject phase composition in Study Designer

The composition and configuration of the subject phases flow can be configured in the following sequence:

  1. Add subject phases that the study needs to follow.

  2. Establish mapping between phases you have previously added to indicate the continuity of those phases in the course of the trial.

  3. Update phase settings to add an extra layer of configuration to better align with study requirements.

  4. Autoderive subject discontinuation to automate the discontinuation of subjects during the study based on specific conditions.

  5. Use additional actions like revoke or redo, delete any phase, run phase validation, and lock or unlock phase composition whenever needed.

In this section:

An overarching clinical trial protocol designed to achieve clinical trial objectives under a unified framework. This approach simplifies clinical development by introducing multiple substudies to operate under the same regulatory and operational entity.

An individual component of a master study protocol with its specific objectives, such as evaluating a product, dose, or subject category. Substudy inherits the core structure and governance from the master one but has its own endpoints.