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For later phase trials, it usually is not necessary to create a complex Epoch and Cohort structure. It may be acceptable to create only a single Epoch and Cohort representing overall ‘Study Conduct’ activities, and instead rely on Activity Plans to help facilitate certain study/site workflows.❗ Please note that in a “head-on” environment
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When setting up the Cohort(s) - do not to tick the “Require Recruitment” tickbox in the “Volunteer Recruitment Allowance section; do not ticket the “Informed Consent” / “Over Volunteering Check” in the “Subject Data Requirements” section. |
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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. |
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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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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.
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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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