1. Release Notes—What's New
  2. What's New
  3. Enhancements to Oracle Argus Safety
  4. CDRH eMDR updates (Enhancement 31836633)

CDRH eMDR updates (Enhancement 31836633)

CDRH has published revised guidelines for eMDR report submission in May 2020, and subsequently in September 2020. To be complaint with the latest regulation updates, Oracle Argus Safety underwent the following changes:

Console changes

  • New countries have been added in the Country standard code list as per the GENC Standard.
  • The GENC3 code attribute is provided in the COUNTRY flexible code list and the GENC3 data has been updated for all existing countries, as well as for new countries.
  • The Authorization Type field length in Console > Business Configuration > Products and Licences > License Configuration was changed to ten characters.
  • The list of countries field in the product license screen used to display the ISO A3 codes assigned to each country. Since the new countries do not have ISO A3 codes, this field now displays the country names with the semicolon as delimiter.
  • The Country name and its corresponding Japanese text have been changed.
    • TAIWAN, PROVINCE OF CHINA is changed to TAIWAN
    • PALESTINIAN TERRITORY, OCCUPIED to PALESTINE, STATE OF
  • The Gender codelist now includes new values as required by the CDRH regulations. The corresponding NCI_CODE data is provided for the new records in the Gender Flexible codelist.
  • Factory data update for Occupation codelist to include Third Party Servicer and and NCI_CODE data is updated for REPORTER_OCCUPATION flexible codelist.
  • The Biosimilar and Pre-1938 check boxes have been provided under the Console > Business Configurations > Products and Licenses > Product License tab.

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

Case form changes

The need to perform dual coding of medical device codes based on Manufacturer or User facility report has been removed in the release. IMDRF coding for Device Problem, Health Impact, Device components, Evaluation codes can be coded from Device tab. Term coding from the Analysis tab is no longer required and the Add/Delete buttons in Analysis > MedWatch Info section > 10. FDA Codes > Device Problem codes are now disabled.

Coding of Patient Problem codes from the following sections is no longer required:
  • The Add button is disabled in Analysis > MedWatch Info section > 10. FDA Codes > Device Problem codes
  • The Select button is removed in Device > Patient Problem and Device Problem Information
  • The Authorization Type field length in Case form > Product > Drug or Device > Product Information was changed to ten characters.
  • The IMDRF Code field length in Case form > Product > Device > Device Component Information was changed to ten characters.

For existing cases having data in Patient Problem codes, we recommend that you perform IMDRF coding for Clinical Signs and Health Impact code by referring to existing data that is present in the Patient Problem codes.

The Biosimilar and Pre-1938 check boxes are provided under the Product Information sub-tab, Common to Device, Drug and Vaccine tabs.
  • For company products, these check boxes are marked based on the data available in the License configuration and are ready-only.
  • For non-company products, you can mark these check boxes as applicable.
  • For the study products, these new fields are populated based on the primary license number selected in Console > Studies Configuration.
  • When unblinded at case level, these new fields are enabled irrespective of the product selected in the Study Drug drop down.

Note:

The Pre-1938 field available under Case Form > Analysis > MedWatch tab will not be used in eMDR.

A new data entry field to capture Serviced by Third Party has been provided under the Device Information section to capture device serviced by third party with values Yes, No, and Unknown.

A new field Exemption number is added in the eMDR report, which is an alphanumeric value provided by FDA to track approved exemptions or variances of adverse event reporting. The typical format is E1234567.

Note:

You must enter Exemption Number as a 7-digit number (without the leading letter E).

For more information, refer to the Argus_Safety_8.2.3_CaseForm_Console_Updates_Summary.xlsx.

Interchange mapping changes

The mapping logic for the following elements has been revised to populate the GENC3 codes instead of the current 3-character ISO codes:
  • MFRCOUNTRY (D3)
  • REPORTERCOUNTRYR3 (E1)
  • UFCOUNTRY (F3)
  • FMFRCOUNTRY (F14)
  • MFRCONTACTCOUNTRYCODE (G1)

Changed country names for TAIWAN and PALESTINE, STATE OF have been updated in the allowed value repository of eMDR, eVAERS, all E2B(R2), and E2B(R3) profiles, to display the revised country names in the Decoded view of ICSR viewer.

Updates for IMDRF codes

According to the latest CDRH guidelines, IMDRF codes can be sent for the Medical Device codes.

The following new elements are provided in the eMDR profile to send IMDRF codes:
  • FDACOMPONENTCODES [F10 Part 3]
  • FDAHEALTHIMPACTCODE [F10 Part 4]
  • MFRCOMPONENTCODE [H6]
  • MFRHEALTHIMPACTCODE [H6]
The mapping logic for the following elements has been revised to populate GENC3 codes instead of the current 3 char ISO codes:
  • FDAPATIENTCODES [F10 Part 1]
  • FDADEVICECODES [F10 Part 2]
  • MFRPATIENTCODE [H6]
  • MFRDEVICECODE [H6]
  • EVALCODEMETHOD [H6]
  • EVALCODERESULT [H6]
  • EVALCODECONCLUSION [H6]

The data length of the Device/Patient/Evaluation Codes elements has been changed from 4 to 7.

The data length of the Device, Patient, and Evaluation Codes elements have been changed from 4 to 7 to send IDMRF codes instead of FDA codes.

Field type of the Device, Patient, and Evaluation Codes elements has been changed from code list field to text code. This avoids allowed values check for the device codes at the time of the eMDR report generation.

Other updates to the eMDR Profile

The following new elements are provided in the eMDR profile:
  • EXEMPTIONNO
  • GENERIC [C6]
  • BIOSIMILAR [C6]
  • PREANDA [C6]
  • PRE1938 [C6]
  • THIRDPARTYSERVICED [D8]
  • COMBINATIONPRODUCT (G4)
The mapping logic for the following elements has been revised:
  • SUSPECTPRODUCTS [C]
  • PREMARKETNUMBER [G4]
The Descriptive name of several elements has been updated according to the latest CDRH regulations. The element number for the following elements in the eMDR Profile and Comments provided in the XSL files has been updated:
  • Device, Patient, or Evaluation Codes elements in F10 to include part numbers.
  • Elements in C, D, and G blocks, as per the latest CDRH regulations.

For more information, refer to the ArgusInterchange823_eMDR (R2) Export Mappings.xlsx > eMDR Mapping sheet.

Parent topic: Enhancements to Oracle Argus Safety