© 2024 IQVIA - All Rights Reserved
Setting Up a Study
- Toma Holtzer
- Michelle Saint Pierre
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.
Add and configure a new study
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.
Setup epoch and cohort structure
Epochs and Cohorts help organize overall study structure in order to help facilitate subject enrollment and data collection workflows. Epoch/Cohort terms and features are built around CDISC standards.
Epochs represent sequential milestones or phases in a trial - for example - Screening, Treatment, Follow Up, etc. Study cohorts represent a groups of subjects based upon a pre-defined or common characteristic.
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.
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.
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.
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.
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.
Creating activity plans
Activity plans organize study forms and events into planned/scheduled assessments.
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.
Activate a study
Subject enrollments and data collection activities can only occur if the study is placed into ‘Active’ status.
Exported and Printed Copies Are Uncontrolled