1. Release Notes—What's New
  2. What's New
  3. Enhancements to Oracle Argus Safety
  4. Reporting updates
  5. Added new data to CIOMS I form

Added new data to CIOMS I form

Summary

New data added to the CIOMS I form and mappings updated (Enhancements 36038908, 32735393, 35697198 and 25807726)

Description

The application is enhanced to include the option to print additional information in the CIOMS I and CIOMS I Local forms, such as an event assessment table, analysis of similar events (ER 36038908) and company comment (ER 32735393). Additionally, dechallenge/rechallenge (ER 35697198) and medically confirmed (ER 25807726) mappings are updated.

Section “7 +13 DESCRIBE REACTION(S) (including relevant tests/lab data)” of the CIOMS I form updates
  • Event Assessment
    • A new check box, Print Event Assessment in the “7 +13 DESCRIBE REACTION(S)” section is added to Console > Code Lists > Argus > Reporting Destination > Report screen to enable printing of the event assessment information in a tabular format. You can check or uncheck this check box to print or not to print the event assessment information for each agency.
    • If the Event Assessment table is enabled in the Reporting Destination, below information is printed in the CIOMS I form and CIOMS I local form and all other data, except Other Serious Criteria, is printed in continuation page:
      • Product
        • The Product Name is printed as in Case Form > Events > Event Assessment > Product Name.
        • For each event verbatim, the list of product names is printed in the same order as in the Event Assessment screen.
        • The printing of event verbatim for every product name is repeated.
      • Serious, Options – Yes, No
        • Value matches seriousness in Case Form > Events.
        • If the event is marked as serious, then Yes is printed.
        • If the event is not marked as serious, then No is printed.
      • Listed, Options – Yes, No
        • Listedness matches the product-event combination in Case Form > Events > Event Assessment > As Determined Listedness for the selected license.
        • Listedness for all other products in the table is calculated on an overall worst case scenario approach, that is, if any of the populated fields is unlisted, the overall assessment is unlisted, as per the existing functionality.
        • Unknown Listedness in the Event Assessment tab is considered Unlisted, as per the existing logic.
      • Reporter Causality – Reporter causality for the product-event combination is printed in Case Form > Events > Event Assessment > Causality as Reported Result.
      • Company Causality – Company Causality for the product-event combination is printed in Case Form > Events > Event Assessment > Causality as Determined Result.
  • Company comment
    • Two new check boxes, Print Case Comment in the “7 +13 DESCRIBE REACTION(S)” section and Print Company Comment in the “7 +13 DESCRIBE REACTION(S)” section are added to the Console > Code Lists > Argus > Reporting Destination > Report screen to enable printing of case comment and/or company comment. You can check or uncheck these check boxes to print or not to print the case comment and/or company comment for each agency.
    • If Company Comment is enabled in the Reporting Destination, data entered in Case Form > Analysis > Company Comment is printed with Company Comment as prefix in the CIOMS I and CIOMS I Local forms.
  • Analysis of Similar Events
    • A new check box, Print Evaluation in light of similar events in the past in the “7 +13 DESCRIBE REACTION(S)” section is added to Console > Code Lists > Argus > Reporting Destination > Report screen to enable printing of the Analysis of Similar Events (AOSE) statement. You can check or uncheck this checkbox to print or not to print the AOSE statement for each agency.
    • If AOSE is enabled in the Reporting Destination, data entered in Case Form > Analysis > Evaluation for similar events is printed with Analysis of Similar Events as prefix in the CIOMS I form and CIOMS I Local forms.
Section “20. DID REACTION ABATE AFTER STOPPING DRUG?” and “21. DID REACTION REAPPEAR AFTER REINTRODUCTION?” of the CIOMS I form updates

Mapping of section 20. DID REACTION ABATE AFTER STOPPING DRUG? in the CIOMS I report derives Dechallenge Results from the Case Form > Products > Product Details screen.

Mapping of section 21. DID REACTION REAPPEAR AFTER REINTRODUCTION? in the CIOMS I report derives Rechallenge Results from the Case Form > Products > Product Details screen.

If data is missing in Case Form > Products > Product Details, then Dechallenge and Rechallenge Results are derived based on the Events > Product - Event details pertaining all suspect products in the case. The preferred order for roll-up from product-event level to product level is Positive > Negative > Not applicable > Unknown.

Section “26. REMARKS” of the CIOMS I form update
  • Case References
    • A new check box, Print Case References in the "26. REMARKS" section, and a selectable field under it containing case references are added to the Console > Code Lists > Argus > Reporting Destination > Report screen to enable printing case references. You can check or uncheck this check box to print or not to print case references for each agency.

    • If Case References are enabled in Reporting Destination, you can select one or more references to print. The respective data entered in Case Form > Additional Information > References > ID is printed with Case References as a prefix in the CIOMS I form and CIOMS I Local forms.

  • Medically Confirmed
    • Mapping of medically confirmed in the CIOMS I form is updated to consider the Medically Confirmed field in the Case Form > General > General Information screen.
    • If data is missing in the Case Form > General > General Information screen, then this data is derived using events from Events > Event Information > Medical Confirmation by HCP. The preferred order for roll-up from event level to case level is True > False.

Note:

These enhancements do not impact ICSR Viewer > View Form > CIOMS.

Parent topic: Reporting updates