A vaccine study is specialized to collect data about specific vaccine protocols, associated immunogens, and adjuvants. The Study Designer described here allows a team to agree upon the necessary study elements in advance and design a study which can be used as a template to create additional studies with the same parameters. This can be particularly helpful when your workflow includes study registration by another group after the study design is completed and approved.
A study created from such a design contains pre-defined treatments, visits, cohorts, and expected study schedule.
If you have a custom module containing a CAVD Study folder type, you can directly create a folder of that custom type named "Vaccine Study" and skip to the next section.
Otherwise, you can set up your own Vaccine Study folder as follows:
Administrator access is required to populate the Overview tab with specific information about the study. This tab need not be filled in to complete other study steps, but it is a useful place to present summmary information.
You may also choose to pre-define the visits or timepoints for your study by clicking Manage > Manage Visits or Manage Timepoints. If you do not pre-define time points, they will be inferred from the data you upload.
The remainder of study design can be done by a user with Editor permissions. The Edit button on each tab opens the same page as administrators can access through the Manage tab.
On the Vaccine Design tab, click Edit. This takes you to the Manage Study Products page. Define the products you will study, including immunogens, adjuvants, and antigens, as described in this topic. Return to this page when finished.
Select the Immunizations tab and click Edit to define immunization treatments and schedule, as described in this topic:
Select the Assays tab and click Edit. Follow the instructions in this topic: Manage Assay Schedule.
Your study is now ready for data collection, integration, and research.
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