Organizations using both a RIM Submissions Vault and a PromoMats Vault can utilize the Spark messaging framework to create a standard Vault to Vault connection. This connection transfers Application, Submission, and Compliance Package information across Vaults and automates the creation and updating of CrossLink documents.

The RIM to PromoMats Connection enables a seamless flow from compliance package generation in PromoMats to Content Plan creation in RIM Submissions, and, if licensed, to the FDA through the gateway via RIM Submissions Publishing , reducing the time required to submit the compliance package to the FDA.

How the RIM to PromoMats Vault Connection Works

When your RIM Submissions and PromoMats Vaults are first connected, Vault creates any existing RIM US Application in PromoMats. Any Applicant records linked to these Applications are also created. Note that, to prevent duplicate records, Vault does not create records if the Link fields match. Vault also does not create any Applicant or Application records in RIM with the same Name field value but different Global IDs as existing records in PromoMats. To ensure that Vault recognizes that these records match, you’ll need to copy the Global ID for the record in RIM and add it to the Link field in PromoMats.

After connecting your Vaults, you must move at least one compliance package to the Submission Ready state. This triggers RIM to pull all Submission Ready eCTD binders from PromoMats to RIM. This eCTD binder must use an Application or Applicant record that is linked to an Application and Applicant record in RIM.

Publication Errors

If at any point there is an issue with the publication, the PromoMats user should move the compliance package to the Revise and Resubmit state in your PromoMats Vault, make the changes required and then move it back to Submission Ready to trigger the update in RIM.

User Exception Messages

You may see a User Exception Message when using this feature. Navigate to Admin > Configuration > Objects > User Exception Items. Click Edit and set the Display values in Business Admin menu checkbox, then click Save. Then, navigate to Business Admin > Objects > User Exception Messages to view the message details. After the issues are resolved, restart the connection by going to Admin > Connections > User Exception Message and clicking Rerun on the message record.

About Record Creation & Update

Vault creates new records in their lifecycles’ starting states. When creating a record through the connection, Vault also populates the Link (link__sys) field on the target record with the source record’s Global ID (global_id__sys). These fields let Vault know which records to update in the target Vault when data is updated in the source Vault.

When users delete documents or object records in one Vault, Vault does not delete the associated documents or object records in the connected Vault.

When publishing source documents or renditions, Vault references the Source for Published Document field. See Working with Submissions Publishing for more details.

Submitting a Compliance Package

Once an eCTD Compliance Package is ready for submission, move it to the Submission Ready state. This triggers the connection to:

  • Create a Submission record in your RIM Vault
  • Copy the Submission record in PromoMats and add the record to the eCTD binder and corresponding documents
  • Create a Content Plan in RIM, if configured
  • Create CrossLinks in RIM to the documents in PromoMats
  • Activate Continuous Publishing

When you send the submission through the FDA gateway, you must add the Actual Submitted Date to the Submission record in RIM. Vault automatically adds this date to the Submission record and eCTD binder and corresponding documents in PromoMats. Vault also moves the eCTD binder to the Submitted state.

Correcting Errors in the Compliance Package

If you need to edit the compliance package after moving it to the Submission Ready state, you must first move it to the Revise and Resubmit state.

You can perform any of the following actions to update the eCTD binder:

  • Remove or add Vault link annotations, linked documents, and anchors
  • Remove or add the Final Video/Audio rendition type on the promotional piece
  • Update the Dissemination/Publication Date
  • Update Form 2253, the Supplementary Form, or the Correspondence Letter

Update the binder as necessary and perform the Regenerate Compliance Package action. Then, move the binder back to the Submission Ready state. This ensures that changes made to the binder are reflected in your RIM Vault.