Content Plans

Submission content plans help you collect the documents that you want to include in a single submission package. Content plans allow you to quickly assess which documents have been included and which documents are missing, and allow you to verify each document’s approval status to see if they are ready to be submitted.

After you’ve created an application and submission, you can use the submission to create a submission content plan.

Image of applications overview in RIM Basics

Vault Admins, RIM Admins, and Submission Managers have access to create content plans in the Submissions tab, while Document Managers do not.

Working with content plans involves the following general steps:

  1. Create the content plan from your submission.
  2. Identify which document types you want to include in the content plan.
  3. Add individual documents to the identified document types.
  4. Approve and version-lock all matched documents.
  5. Create a binder of the documents you want to submit and export it to a ZIP file.
  6. If you are not publishing in Veeva RIM Basics, outside of Vault, share the ZIP file with your third-party publishing tool to send to the Health Authorities.
  7. Lock the content plan and binder to reflect the published output that was submitted to the Health Authorities.

Content Plan Completeness

Before a content plan can be considered ready for use, all content plan items must be in a Complete state.

Content Plan Status Icons

Active, but no document matches: Add a new document or match an existing document to that item.

Two or more documents matched: Click View in Mini-Browser to the right of each matched document and either remove the extra documents or select Split Content Plan Items from the content plan item Actions menu. Vault splits the content plan items so that each added document has its own content plan item.

Matched to an unapproved document: Click View in Mini-Browser to the right of the associated document in the content plan tree to open it in a separate pop-up window. Manually approve the document or initiate the document approval workflow as needed.

Matched to an approved doc, but not yet version-locked: Version-lock the document.