CSCR-105-PtSafety-Link to Product

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

Issue

• 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.

Recommendation

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

Rationale

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

Discussion

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.

Recommended Action Items

• Acceptance of the recommendations listed above and modification of the clinical statement model.