Regulatory Open Forum

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  • 1.  CER Writing for Beginners

    Posted 09-May-2021 09:58
    I'm teaching a class on CER Writing for Beginners next week.  Is anyone willing to share your Top Three or Top Ten "take away" messages when learning what is most important to write about in a CER? Or conversely the most common deficiencies you have seen for a CER Or JUStification document?

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    Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
    President and CEO
    Frestedt Incorporated (www.frestedt.com)
    Saint Louis Park MN
    United States
    612-219-9982
    jf@frestedt.com
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  • 2.  RE: CER Writing for Beginners

    Posted 10-May-2021 03:33
    Hello Joy,

    In no particular order:
    • Well organised clinical evaluation documents with clearly defined headings and sections so it is easy to find information, i.e. Safety Summary, State of the Art.
    • Literature search protocol which is detailed enough for not only a review, but someone can repeat or modify in the future knowing what was originally done.
    • Reference when available, there is much information contained in a Technical Documentation file so it does not need to be repeated in the clinical evaluation - just one more place for text to get disconnected.

    Have a nice time teaching !

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
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    Original Message


  • 3.  RE: CER Writing for Beginners

    Posted 10-May-2021 06:28
    Hi Joy,

    Besides what has been said by Richard, I would like to add "Identification and Appraisal of the data".

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    Monoj Mon Kalita, PhD
    Senior RA Specialist
    New Taipei City
    Taiwan
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    Original Message


  • 4.  RE: CER Writing for Beginners

    Posted 10-May-2021 08:51
    Edited by Adrienne Carmack 10-May-2021 08:51

    Hi Joy,

    I would like to add a key in all writing (but especially technical writing), which is writing for your audience--in this case, reviewers who must complete MDCG 2020-13. Make it easy for reviewers to find what they need, and write clearly and succintly.

    Best,
    Adrienne



    ------------------------------
    Adrienne Carmack, MD
    Medical Lead EU MDR
    BD
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    Original Message


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