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Difference between revisions of "CSCR-105-PtSafety-Link to Product"
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(New page: Submitted by: <<Mead Walker>> Revision date: <<2009/06/29>> Submitted date: <<2009/06/29>> Change request ID: <<CCSR-105-CSCG-Link to Product>> Contents [hide] 1 Issue The current RM...) |
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| − | 2 | + | Back to [[Clinical Statement Change Requests]] page. |
| − | + | {|width=100% cellspacing=0 cellpadding=2 border=1 | |
| + | || '''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. | ||
| + | |||
| + | == Discussion == | ||
| + | |||
| + | |||
| + | == Recommended Action Items == | ||
| + | * Acceptance of the recommendations listed above and modification of the clinical statement model. | ||
| + | |||
| + | == Resolution == | ||
Revision as of 20:23, 29 June 2009
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_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.
Discussion
Recommended Action Items
- Acceptance of the recommendations listed above and modification of the clinical statement model.
