A
study product is a specific combination of immunogen, adjuvants, and antigens used in a vaccine treatment. Definitions of study products, combined with
treatment protocols and
schedules can be defined and shared across multiple studies.
Studies can be configured to share some schema and definitions, enabling coordination of data collection across multiple studies. The team can agree upon the necessary elements in advance, obtain any necessary approval based on this 'template', and a number of studies in a given project can share the same pre-defined study products, treatments, and expected schedule.
To define Study Products within a study:
- Select (Admin) > Manage Study > Manage Study Products.
Populate Dropdown Options
When you insert new
Immunogens, Adjuvants, and Challenges you select values for
Challenge Type, Immunogen Type, Gene, SubType, and Route from lists specified either at the project- or folder-level. When defined at the project level, the values stored are made available in all studies within the project. This walkthrough suggests defining folder level tables; to define at the project level, simply select the Project branch of each configure option.
- Select Configure > Folder > Challenge Types.
- A new browser tab will open.
- Use (Insert data) > Insert New Row (or Import bulk data) to populate the StudyDesignChallengeTypes table.
- When all additions to the table have been submitted, select (Admin) > Manage Study > Manage Study Products.
- Repeat for each:
- Configure > Folder > Immunogen Types to populate the StudyDesignImmunogenTypes table.
- Configure > Folder > Genes to populate the StudyDesignGenes table.
- Configure > Folder > SubTypes to populate the StudyDesignSubTypes table.
- Configure > Folder > Routes to populate the StudyDesignRoutes table.
- Select (Admin) > Manage Study > Manage Study Products again.
Define Study Products
Each immunogen, adjuvant, and challenge used in the study should have a unique name and be listed in the panels on this page. Enter information to each panel and click
Save when finished.
Define Immunogens
The immunogen description should include specific sequences of HIV antigens included in the immunogen if possible. You should also list all the expected doses and routes that will be used throughout the study. When you add the immunogen to an immunization treatment, you will select one of the doses you listed here.
Click
Add new row to open the data entry fields - initially only "Label" and "Type" will be shown. Click
Add new row under "HIV Antigens" and "Doses and Routes" to add values to the associated fields.
You can delete immunogens or any component rows by clicking the trash can icon to the left of the fields to delete. You will be asked to confirm the deletion before it occurs.
Define Adjuvants
Click
Add new row in the Adjuvants panel and enter the label for each adjuvant. Click
Add new row to add dose and route information. Again, list all the expected doses and routes that will be used throughout the study. When you add the adjuvant to an immunization treatment, you will select one of the doses you listed here.
You can delete an adjuvant or dose/route information by clicking the trash can icon for the fields. You will be asked to confirm before deletion occurs.
Define Challenges
Click
Add new row in the Challenges panel to add each challenge required. Click
Add new row for "Doses and Routes" to add all the options you will want to have available when you later add this challenge to a treatment.
Next Step
Once you have defined study products, remember to click
Save. Then you can package them into specific immunization protocols, or treatments.
Additional Resources
