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.
- 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.
- 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 underCase 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.
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
- 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.
- FDACOMPONENTCODES [F10 Part 3]
- FDAHEALTHIMPACTCODE [F10 Part 4]
- MFRCOMPONENTCODE [H6]
- MFRHEALTHIMPACTCODE [H6]
- 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
- EXEMPTIONNO
- GENERIC [C6]
- BIOSIMILAR [C6]
- PREANDA [C6]
- PRE1938 [C6]
- THIRDPARTYSERVICED [D8]
- COMBINATIONPRODUCT (G4)
- SUSPECTPRODUCTS [C]
- PREMARKETNUMBER [G4]
- 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