Vault supports mapping Case details to the standard postmarket forms for reporting adverse events related to medical device and regenerative medicine products to the PMDA. Vault formats forms as either a PDF or XML file based on the Transmission Document Type of the associated Transmission.
Review the following articles to learn how Vault maps information to generate compliant forms:
Prerequisite
Your Admin must enable PMDA Medical Device and Regenerative Medicine Reporting.
R.2 Attachments Section
For all postmarket medical device and regenerative medicine forms, Vault generates the R.2 Attachments section when applicable. Vault encodes Case attachments with the Case > Source > Attachment document type and the Retransmit field set to Yes. Vault does not encode documents with the Retransmit field set to No or blank.
Vault may exclude attachment contents on Transmissions for domestic Cases or Localized Cases with previous Transmissions that included the attachment to the same reporting destination.