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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.
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Setup epoch and cohort structure
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Please note that when the Volunteer Database is switched on, you would also need to create Cohort Assignments for individual Volunteers manually. When the Volunteer Database is switched off (ClinSpark is in “headless mode”) ClinSpark automatically creates the Cohort Assignments and activates the Activity Plans and Volunteers upon enrolment. |
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Setup study events / visit schedule
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.
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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.
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Creating activity plans
Activity plans organize study forms and events into planned/scheduled assessments.
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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.Widget Connector
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Activate a study
Subject enrollments and data collection activities can only occur if the study is placed into ‘Active’ status.
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