Inclusion in Argus Safety Versions 8.0.1 and Later of FDA Adverse Event Codes as per FDA CDRH eMDR System Enhancements
(Doc ID 2363145.1)
Last updated on AUGUST 13, 2018
Applies to:Oracle Argus Safety - Version 8.0.1 and later
Information in this document applies to any platform.
25-Apr-2018: document updated to incorporate CDRH changes from 29-Mar-2018 which will be implemented by July 2018.
05-Jun-2018: SORTBY added to scripts INSERT_CFG_MEDWATCH_CODES.sql and INSERT_CFG_MEDWATCH_PPC_CODES.sql
25-Jun-18: additional codes included in INSERT_CFG_M2_PPC.sql
26-Jun-18: additional codes included in INSERT_CFG_MEDWATCH_CODES.SQL and INSERT_CFG_MEDWATCH_PPC_CODES.SQL
The Center for Devices and Radiological Health (CDRH) published upcoming Electronic Medical Device Reporting (eMDR) system enhancements on 11-Dec-2017 and subsequently on 29-Mar-2018.
This included the list of FDA Adverse Event codes to be used in section F10 (Event Problem Codes) and section H6 (Event Problem and Evaluation Codes) of the eMDR report in order to be harmonized with the IMDRF Adverse Event Reporting Terminologies.
The FDA Coding Resource page has details on updates to FDA Adverse Event Codes.
This is the link to the current and future MDR Adverse Event Codes.
The list contains new codes and inactive codes that are not accepted in eMDR from July 2018.
This document provides a solution to the updated eMDR requirement until it is provided as a part of the standard Argus product offering; this is logged as enhancement request 27577310 - eMDR:Update the device problem codes used for F10, H6 as per DPC hierarchy which will be implemented in Argus 8.2.
The solution covers the following:
- Inserts new Device and Evaluation codes to the factory data (CFG_MEDWATCH_CODES table)
- Drops existing codes in CFG_M2 table for Device and Evaluation and inserts only valid codes as per latest FDA CDRH eMDR requirements
The solution does not provide the following:
- Scripts are not provided to update the Term description or Definition for the existing records as only the codes are used in the eMDR reports
- Scripts are not provided to mark a term as Inactive in CFG_MEDWATCH_CODES, the current table structure does not have this capability. The inactive codes could be renamed with a prefix or suffix to indicate they are inactive
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