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Description of Trend

Click on Description of Trend from the menu on the left:

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  1. Enter the background information:

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  2. Specify if there are IMDRF codes (Annex A) or in-house codes:

    • Answer Yes if there are IMDRF codes applicable and enter the code(s):

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    • If you answer No, enter the Code and the Term of the in-house/MedDRA codes:

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  3. Specify if there are IMDRF codes applicable (Annexes E and F) or in-house codes:

    • Answer Yes if there are IMDRF codes applicable and enter the code(s):

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    • If you answer No, enter the Code and the Term of the in-house/MedDRA codes:

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  4. Enter the summary of the root cause analysis and the actions to be taken or already implemented to reduce the risks for the users/patients:

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  5. Upload a Trend report document (PDF file only):

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  6. Enter any general comments:

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