A pre-defined study contains pre-defined visits, datasets schemas and specimens. Note that the datasets in this study are not pre-populated, so you still need to Import Data Records.

Steps

Design the Study

1. Sign in with an Admin account
2. Add a Vaccine Study Protocol web part to the appropriate project page
3. Click New Protocol.
4. Enter: Protocol Name (required), Investigator, Grant, Species, Overview
5. Enter: Vaccine Design, Immunogens and Assays. To add more rows to any table, click the * at the beginning of the last, blank row in the appropriate table.
6. You must schedule at least one assay. To choose a time point, click the title bar that says "Click to create a Time point." Enter and save a time point, then click the checkbox for each assay that should be scheduled at that time point.
7. Click Save to save and continue editing or Finished to Save and review your Study
8. When when you click Finished, you'll see your Study Protocol Definition.

Optional: Create Revisions by Editing the Study Design

1. You're now on the Study Protocol Definition Page.
2. If you wish to edit, click the edit button at the bottom of the page and create a new revision of this study.
3. When finished, click Finished. You'll return to the Study Protocol Definition page.

Create the Study Folder

1. Start on the Study Protocol Definition Page.
2. Select the desired version of the study design from the "Revisions" drop-down menu and click "Create Study Folder"
3. Choose the destination folder from the "Parent Folder" dropdown menu.
4. Click Next
5. Follow the instructions on the next page to create an Excel workbook with Participant information.
6. Click Next
7. On the next page, paste in your Excel table.
8. Follow the instructions on the next page ("Create Study Folder: Sample Information"), then click Continue
9. On the next page, paste your Excel table.
10. Click Continue
11. On the Confirm page, click "Finish"
12. You'll now be on the home page of your new Study. You can view the protocol used to create this study by clicking on the "View Complete Protocol" link in the "Study Protocol Summary" section.

Study Elements Defined and/or Populated

1. Visits
2. Datasets: Dataset schemas have been defined but not data values have not been uploaded.
3. Specimens