CSCR-105-PtSafety-Link to Product

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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_RM620000UV. 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.

Recommended Action Items

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