Question:

How to add a new FDA 2253 form to Vault? 

Answer:

To upload and configure the FDA 2253 form and/or FDA 2253 Supplemental form:

1. Download the latest form from the FDA website if the user does not have it.
2. In Vault, upload the form as a Health Authority form.
3. Update the form’s sharing settings with the user(s) and/or group(s) that will need edit access to the form such as Regulatory and Submission Coordinator (depending on your configuration).
4. Open the Admin tab and navigate to Configuration --> Objects --> XML Elements.
5. Click Edit.
6. Select Display in Business Admin menu.
7. Click Save.
8. Navigate to Business Admin --> XML Elements.
9. Locate the Root form either by navigating through each page or using search.
10. Click on the Root link.
11. Click Edit.
12. In the Form Template field, locate the form that is uploaded and click Save. Vault maps the form fields to the XML fields.

Related Documentation:

Vault Help Documentation: N/A