Animal and Plant Health Inspection Service
Adverse Event Reporting - Industry Guidance for the AS2 Gateway
Actions
This page contains helpful information for veterinary biologics manufacturers submitting Adverse Event Reports to the Center for Veterinary Biologics (CVB) via the AS2 Gateway. Information provided is intended to be used in conjunction with the Guidance document on Individual Case Safety Report Format for Submission to USDA APHIS-CVB.
Section 1.5
Document number 6: USDA APHIS-CVB ICSR HL7 Vocabulary Lists
Section 2.11
In the table below are the example XML files provided for reference purposes in Section 2.11 of the Guidance document on Individual Case Safety Report Format for Submission to USDA APHIS-CVB.
| Filename |
Content |
| Sample_USDA_AER.xml |
A single adverse event report
|
| Sample_USDA_AER_PPR.xml |
A single adverse event with associated product defect report |
| Sample_USDA_PPR.xml |
A single product defect with no adverse event report |
| Sample_ack_USDA_Invalid.xml |
An acknowledgement for an invalid report (xml that does not comply with the schema) |
| Sample_ack_USDA_Reject.xml |
An acknowledgement for a report that was structurally valid but was rejected due to failing business rules
|
| Sample_ack_USDA_Accept_warn.xml |
An acknowledgement for a valid report that was accepted with a warning |
| Sample_ack_USDA_Accept.xml |
An acknowledgement for a valid report that was accepted without warnings |
| Sample_ack_USDA_Mixed.xml |
An acknowledgement for a valid batch report for ICSRs with a mixture of statuses (one accepted, one warning, one rejected) |
An official website of the United States government
