[
Video Overview: Study Designer - treatment data and assay schedule]
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:
- If you do not already have a local server to use for this tutorial, Install LabKey Server (Quick Install)
- Download this folder archive: vaccineStudy.folder.zip
- Create a new folder of type Study, and, to match the screencaps in this walkthrough, name it "Vaccine Study".
- Click Import Study.
- Click Browse or Choose File, select the zipped archive you just downloaded.
- Click Import Study from Local Zip Archive.
- When the pipeline import is complete, click Vaccine Study 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. 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.
Set Up Vaccine Design 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.
Set Up Immunizations Tab
Select the
Immunizations tab and click
Edit to define immunization treatments and schedule, as described in this topic:
Set Up Assays Tab
Select the
Assays tab and click
Edit. Follow the instructions in this topic:
Manage Assay Schedule.
Next Steps
Your study is now ready for data collection, integration, and research.
