Updated IMDRF D0108 Code Appears Duplicated or Linked to Unrelated Row
(Doc ID 2915961.1)
Last updated on DECEMBER 04, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 8.4 and laterInformation in this document applies to any platform.
Goal
After the upgrade to 8.4, where the following enhancement of IMDRF codes was implemented:
CFG_FDA_IMDRF_CODES repository updates
Summary
Updates to CFG_FDA_IMDRF_CODES repository based on the new Annexures released by IMDRF and FDA (Enhancement 31498878)
Description
The CFG_FDA_IMDRF_CODES repository has been enhanced to include the IMDRF Maintenance updates released on March 5, 2021:
• Annex A: Modified 2 terms (A0908, A15).
• Annex B: Added 1 new term (B23) and modified 1 term (B16).
• Annex C: Added 1 new term (C23) and modified 1 term (C19).
• Annex D: Added 4 new terms (D0107, D0108, D1501, D18) and modified 3 terms (D10, D1107, D12).
• Annex E: Added 2 new terms (E2120, E2342) and modified 23 terms (E0105, E010904, E0115, E0135, E0304, E0508, E0710, E0749, E082901, E0835, E0843, E1101, E1305, E1409, E1412, E1625, E1904, E1905, E2106, E2119, E231201, E231501, E2336).
• Annex F: Modified 5 terms (F14, F2204, F2305, F25, F26).
• Annex G: Added one term (G07002) and modified 9 terms (G02011, G0201501, G02020, G03006, G0405202, G04095, G04130, G0600102, G0600601).
Summary
Updates to CFG_FDA_IMDRF_CODES repository based on the new Annexures released by IMDRF and FDA (Enhancement 31498878)
Description
The CFG_FDA_IMDRF_CODES repository has been enhanced to include the IMDRF Maintenance updates released on March 5, 2021:
• Annex A: Modified 2 terms (A0908, A15).
• Annex B: Added 1 new term (B23) and modified 1 term (B16).
• Annex C: Added 1 new term (C23) and modified 1 term (C19).
• Annex D: Added 4 new terms (D0107, D0108, D1501, D18) and modified 3 terms (D10, D1107, D12).
• Annex E: Added 2 new terms (E2120, E2342) and modified 23 terms (E0105, E010904, E0115, E0135, E0304, E0508, E0710, E0749, E082901, E0835, E0843, E1101, E1305, E1409, E1412, E1625, E1904, E1905, E2106, E2119, E231201, E231501, E2336).
• Annex F: Modified 5 terms (F14, F2204, F2305, F25, F26).
• Annex G: Added one term (G07002) and modified 9 terms (G02011, G0201501, G02020, G03006, G0405202, G04095, G04130, G0600102, G0600601).
Searching in conclusion terms one finds two records of D0108 as follows:
Scrolling down one sees:
Another check in a corresponding table (CFG_FDA_IMDRF_CODES) confirms the following:
This seems like IMDRF code is added wrongly as D0108 for FDA code 44. This should be D1501, as shown below:
Solution
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In this Document
| Goal |
| Solution |
| References |