Within a study, you can roll up one or more study products into immunization treatments, then schedule when those treatments are to be given to members of various cohorts. The treatments and schedule can be specific to a single study folder, or can be standardized and shared across multiple studies within a project.

To define treatments within a study:

  • Open the Immunizations tab.
  • Click Manage Treatments.

Populate Options

You should already have defined Immunogens, Adjuvants, and Challenges on the Manage Study Products page. This process includes populating the dropdown menus for various fields used in defining treatments.

Your study should also have already defined the cohorts and timepoints or visits you plan to use for the vaccine treatment schedule. Note that whether your study is visit- or time-based, the process in setting up the treatment schedule is the same. The exception is that with visits, you have the additional option to change the order in which they appear on your treatment schedule.

Define Treatments

Treatments are defined as some combination of the immunogens, adjuvants, and challenges already defined in your folder. A treatment must have at least one adjuvant or immunogen, but both are not required.

Note: If you are using a CAVD folder, you will not see the "Treatments" panel and will instead add treatment information directly to a standalone version of the treatment schedule panel.

  • Click Add new row in the "Treatments" section.
  • Enter the Label and Description.
  • Click Add new row for the relevant section to add Immunogens, Adjuvants, and/or Challenges to this treatment. Note that if there are no products defined for one of these categories, the category will not be shown.
    • Select from the dropdowns listing the products and dose and route information you provided when defining the product.
  • Click Save when finished.

You can edit or delete the treatment, and add more at any time by returning to Manage Treatments.

Define Treatment Schedule

Once you've defined the contents of each treatment, you can set the schedule for when treatments will be given and to whom. Participant groups, or cohorts may already be defined in your study or you can define cohorts directly from this page by giving them a name and participant count.

  • The initial treatment schedule is prepopulated with the cohorts defined in your study.
  • To add additional cohorts, click Add new row and enter the name and count.

The initial treatment schedule does not prepopulate with the visits defined in the study. Only visits involving treatments need to be added to this schedule.

Note that your study can either be visit-based or date-based. This description uses the word "visit" to refer to either type of tracking; if you use timepoints, the steps are the same but buttons and titles will use the other name. The one difference is that you have the option to change the display order of visits in the treatment schedule table by clicking change visit order.

  • In the Treatment Schedule section, click Add new visit.
  • In the Add Visit popup, either:
    • Select an existing study visit from the dropdown or
    • Create a new study visit providing a label and range.
  • Click Select or Submit respectively to add a new column for the visit to the treatment schedule.
  • For each cohort who will receive a treatment at that visit, use the pulldown menu to select one of the treatments you defined.
  • Repeat the process of adding new visit columns and selecting treatments for each cohort as appropriate for your study.
  • Click Save. Only the visits for which at least one cohort receives a treatment will be saved.
  • View the Treatment Schedule on the Immunizations tab.
  • Hover over the ? next to any treatment on the schedule to see the definition in a tooltip.

CAVD Folder Treatment Schedule

In a CAVD folder, study products are not rolled into a "Treatments" table prior to defining the Treatment Schedule. Instead, after adding cohort rows and visit (or timepoint) columns to the treatment schedule, the user clicks an entry field to directly enter the components of the immunization treatment given to that cohort at that time. The popup lists all defined products with checkboxes to select one or more components.

Click OK to save the treatment, then Save to save the treatment schedule. The schedule will show a concatenated list of product names; hover over the "?" to see details including dose and route information for each product included.

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