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.
Create Vaccine Study Folder
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:
- Log in to your server and navigate to your "Tutorials" project. Create it if necessary.
- If you don't already have a server to work on where you can create projects, start here.
- If you don't know how to create projects and folders, review this topic.
- Create a new subfolder named "Vaccine Study". Choose folder type "Study" and accept other defaults.
- Click Import Study.
- Confirm Local zip archive is selected, then click Browse or Choose File and select the zipped archive you just downloaded.
- Click Import Study.
- When the pipeline import is complete, click Overview to return to the home page of your new study.
Other Admin Tasks
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.
- Click the Manage tab.
- Click Change Study Properties.
- Enter Label, Investigator, Description and other study details as desired.
- Click Submit.
You may also choose to pre-define the visits or timepoints for your study by clicking Manage > Manage Visits or Manage Timepoints
. The folder archive downloaded above is a visit-based study. 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 Manage
links on each tab open the same pages administrators can access through the Manage
Set Up Vaccine Design Tab
On the Vaccine Design
tab, click Manage Study Products
. Define the products you will study, including immunogens, adjuvants, and antigens, as described in this topic. Return to this page when finished.
Set Up Immunizations Tab
Select the Immunizations
tab and click Manage Treatments
to define immunization treatments and schedule, as described in this topic:
Set Up Assays Tab
Select the Assays
tab and click Manage Assay Schedule
. Follow the instructions in this topic:
Your study is now ready for data collection, integration, and research. If you intend to generate multiple vaccine study folders using this one as a template, follow the steps in Export / Import a Folder