Page Comparison

Summary

The following content provides an overview of processes involved with setting up a later phase multi-site study in ClinSpark. This is applicable to ClinSpark users who perform administrative functions, such as establishing site and study configurations.

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When a new study is ready to be setup and used in ClinSpark, users will navigate to Administration > Studies component to complete a basic setup step.INSERT VIDEO HERE

Setup epoch and cohort structure

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In order to begin building out data collection forms and activity plans, study events must first be established. These typically represent more specific study days and visit schedule for a trial. This also includes the addition of Unscheduled and Common event types.INSERT VIDEO HERE

Creating and locking forms

Once study events are created, study designers can build out data collection forms. The following video demonstrates this workflow using a simple integrated device ECG (RScribe) form.INSERT VIDEO HERE

Creating activity plans

Activity plans organize study forms and events into planned/scheduled assessments.INSERT VIDEO HERE

Other study metadata and base forms

A final and optional step of late-phase study setup is to establishing certain metadata and base forms. Specific study protocols or requirements may require this be completed. ClinSpark will also warn users when managing study status (changing from ‘Design’ to ‘Active’) if any required metadata or base forms are missing. Typically however the need to add in Eligibility, Informed Consent, and Over-Volunteering forms is not required.INSERT VIDEO HERE

Activate a study

Subject enrollments and data collection activities can only occur if the study is placed into ‘Active’ status.INSERT VIDEO HERE