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Unique form management

In the Study Designer application, you can design unique forms to be used in study .

A unique form is a template case report form (CRF) that serves as a starting point for creating new forms for different visits of the clinical trial. Unique forms are stored in a separate folder under the CRF DESIGN tab as they are designed to be reusable as a blueprint for creating other CRFs in the study visits. Unique forms also provide a centralized option to maintain CRFs of different visits, as modifying a unique form automatically updates the other forms created based on that unique CRF.

Important

For master study and its substudies, you need to create the unique forms individually, they are not inherited from the master study to its substudies.

Unique forms in SD
Figure 1. Unique forms in SD

You can learn more about actions that can be done with unique forms in the following sections:

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

An occurrence in a clinical trial in which the subject comes to a site to receive treatment, undergo some tests, or complete other required procedures.

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.