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CSCR-105-PtSafety-Link to Product

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Back to Clinical Statement Change Requests page.

Submitted by: Mead Walker Revision date: <<Revision Date>>
Submitted date: 29-Jun-09 Change request ID: CSCR-105


  • The current RMIM for adverse event reporting, the ICSR includes a model that is based on the clinical statement, but it is not a legal restriction of that model. We would like, to meet ballot comments and for other reasons, to make the model known as "Product Reporting Relevant Information" such a legal restriction, and, perhaps, to replace it with the clinical statement CMET.
  • However, in order to do that, we the current clinical statement references to consumable items in substance administration, to products in Supply, to devices in procedure to be expanded to support the R_ProductReportable CMET - COCT_RM630000UV. In addition, we would like to see a product participation added to Act to support the reporting of product defects (detected outside of a substance administration or procedure.


  • That the needed references to the R_ProductReportable RMIM be added to the clinical statement.


  • This step is needed in order for the clinical statement model to support the needs of adverse event and product defect reporting.


Key question is whether we should include the ProductReportable CMET by reference or validate that is derivable.

  • Challenge is that we are not clear on the guidelines when to include a CMET, when to just be able to derive, and when it should be excluded.
  • Want to assess first whether CMET should be included before comparing in detail the models.
  • Do we need to have participation/relationships in stubs where domains can put what they need.

  • 1-Oct-09 - Mead provided the following additional information.
    • Here is a list of areas where the clinical statement model could be changed so that its CMET could be used directly by the ICSR.
    • Substance Administration/consumable
      • The current model indicates that either Administrable Material, or R_Medication can be consumed in a substance administration. In the ICSR, the consumable participation is linked to the R_ProductReportableCMET.
      • This allows reporting to touch on the use of non-medicinal products. For example, adverse events linked to food consumption, to consumption of dietary supplements, to application of cosmetics.
    • Supply/product
      • The current model indicates that product supply is linked to a manufactured product role that can be played by a labeled drug, or by a generic material item. Consistency would suggest that the R_ProductReportableCMET be used for this participation. It is not currently used in the ICSR, since product reporting needs to capture, not simply the supply of a product for its “end use”, but also the movement of a product along the full supply chain from manufacture, through distribution, to retail distribution for final use.
      • This allows reporting of a contaminated product to identify the source of a product for which problems are detected, and also to indicate parties to whom the product has been distributed to.
    • Procedure/device
      • The current model indicates that the device participation is liked to a manufactured product role that can be played by a labeled drug, or by a generic material item. In the ICSR, the device participation is linked to the R_ProductReportableCMET.
      • This allows reporting to capture a wide range of information (beyond the current capabilities of clinical statement) for adverse events that are linked to medical devices.
    • In addition, the ICSR has a need for Act/product
      • The ICSR currently allows a “naked act” to be associated with the R_ProductReportableCMET.
      • This allows reporting to capture information for a product in cases where a product defect has been discovered before the product has been administered or otherwise used. In such cases, a wide range of product related information is captured.

Recommended Action Items

  • Acceptance of the recommendations listed above and modification of the clinical statement model.
  • Sep 10, 2009
    • Consider adding choice and/or replacing choices in CS with a CPM CMET.
    • May need a new CMET to increase replacement.
    • Need Rx involvement to decide.
    • Mead will refine the proposal to indicate specifically what to add and/or replace with existing or new CMET.
    • We then will review with Rx whether this can work.
  • Oct 1, 2009
    • Consumable/AgentChoice
      • Cannot replace AgentChoice with Universal CPM CMET
      • Cannot replace Orderable Medication CMET with Universal CPM CMET.
      • Only option to add R_ProductReportableCMET as choice.
    • DeviceProductChoice
      • Proposal to add R_ProductReportableCMET for both Device and Product participation.
      • Concern that R_ProdcutReportable CMET is not just for Device


  • Motion to add R_ProductReportable CMET as a choice to Consumable/AgentChoice. Mead Walker, Rik Smithies.
    • Against: 0; Abstain: 0; In Favor: 5
  • Motion to add R_ProductReportable CMET into a nested choice within DeviceProductChoice where R_ProductReportable CMET and Manufactured Product class are the choices for Device. Mead, Rik.
    • Against: 0; Abstain: 2; In Favor:3