CBER eVAERS changes (Enhancement 31557002)

CBER published revised guidelines for eVAERS report submission in June 2020.

To be compliant with the latest regulation updates, Oracle Argus Safety underwent several changes.

Interchange mapping changes

As per the CBER guidelines, if a reportable malfunction occurred while using the device constituent parts of combination products marketed outside the Unites States, then the Combination Product applicant is required to submit Malfunction reports to FDA if the following conditions are met:

• there is a similar device that is part of Combination Product constituent in a US-marketed combination product
• the malfunction is likely to occur in the US-marketed combination product.

A new element, OTHERDRUGCHARACTERIZATION [G.k.1.a], is provided to identify the similar devices within the eVAERS report.

The following are the new elements in the updated eVAERS profile with the element number, name, mappings, allowed null flavors, and validations:

• MANUFACTURERADDRESS [FDA.G.k.12.r.7.1b]
• DEVICEUSAGE [FDA.G.k.12.r.8]
• DEVICELOTNUMBER [FDA.G.k.12.r.9]
• OPERATOROFDEVICE [FDA.G.k.12.r.10a]

In prior releases, the elements within the Primary source(s) of information [C.2.r] block ignored the protect confidentiality flag for all reporters if the primary reporter's country was United States and the protect confidentiality flag was considered for all reporters if the primary reporter's country was not United States.

In prior releases, most of the elements within Patient (D) block were populated with "None" for Malfunction reports.

The mappings for these elements within Patient (D) block has been revised to send the text "None" only when the product for which report was scheduled was not administered on the patient. To populate the Drug block with additional criteria for similar devices, the DRUG [G.k] element was revised.

For Vaccine Facility/Patient/Reporter Country as US, if the value entered in the State field is a two character text, compare the value with the State_Code attribute of the US_States code list. For valid values, the code is populated for the following elements:

• VACCFACILITYSTATE [FDA.G.k.4.r.14.3]
• PATIENTSTATE [FDA.D.1h]
• REPORTERSTATE [C.2.r.2.5]

If its a single entity combination , Trade name is picked up from the console and not at the case form level.

For single entity combination products, trade name is fetched from Console, the BRANDNAME [FDA.G.k.12.r.4] element is affected.

If the message type is expedited, and the timeframe between 15 to 30 days, the value of the FULFILLEXPEDITECRITERIAR3 [C.1.7] element is sent as false in additional condition:

The validations or conformance rules for the VACCFACILITYCOUNTRY [FDA.G.k.4.r.14.4] element have been removed from the eVAERS profile.

The validations or conformance rules for the following elements have been added or revised:

• PATIENTGIVENAME [FDA.D.1b]
• PATIENTFAMILYNAME [FDA.D.1d]
• PATIENTSTREETADDRESS [FDA.D.1e]
• PATIENTCITY [FDA.D.1g]
• PATIENTSTATE [FDA.D.1h]
• PATIENTCOUNTY [FDA.D.1i]
• PATIENTPOSTCODE [FDA.D.1k]
• PATIENTCOUNTRYCODE [FDA.D.1j]
• PATIENTTEL [FDA.D.1l]
• PATIENTEMAILADDRESS [FDA.D.1m]
• DRUGCHARACTERIZATION [G.k.1]
• VACCFACILITYSTATE [FDA.G.k.4.r.14.3]
• MALFUNCTION [FDA.G.k.12.r.1]

The Xpath of the following elements has been updated:

• PATPASTDRUGMPIDVERSION [D.8.r.2a]
• PATPASTDRUGMEDICINALPRODID [D.8.r.2b]
• PARPASTDRUGMPIDVERSION [D.10.8.r.2a]
• PARPASTDRUGMEDICINALPRODID [D.10.8.r.2b]
• DRUGMPIDVERSION [G.k.2.1.1a]
• DRUGMEDICINALPRODID [G.k.2.1.1b]
• VACCMPIDVERSION [FDA.G2.k.2a]
• VACCMPID [FDA.G2.k.2b]

The Xpath for Null flavors for the following elements has been updated:

• STUDYREGCOUNTRY [C.5.1.r.2]

Device code mapping updates (Enhancement 31199458)

Based on the data available for the device code under the Product > License, mapping for the PRODUCTCODE [FDA.G.k.12.r.6] element is provided.

For more information, refer to the ArgusInterchange823_E2B (R3) Export Mappings.xlsx.