Regulatory Open Forum

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  • 1.  GUDID Manual Submission

    Posted 29-Aug-2016 15:01

    Thank you to everyone who takes the time to answer questions and share their experience on this exchange.  It is educational even when it does not immediately apply.  Now, my question...  

    We will be submitting our GUDID information manually.  We have applied for our GUDID account and received a login & password that only work for the test site.  How do we gain access to the live site to enter our information? 

    The GUDID HelpDesk warns that you can expect a response in 2-3wks.  Hoping someone who has submitted data manually would be able to explain what to expect.  Thank you!

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    Belinda Labourdette
    Dover NH
    United States
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  • 2.  RE: GUDID Manual Submission

    Posted 30-Aug-2016 09:43

    Thank you Lena Cordie for pointing me in the right direction.  It appears the problem with access lies in our initial application submitted in which HL7 SPL was selected and now the decision has been made to manually enter the data.  The saga continues. 

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    Belinda Labourdette
    Dover NH
    United States



  • 3.  RE: GUDID Manual Submission

    Posted 30-Aug-2016 14:25
    Belinda,

    "...The saga continues...."

    It should be one of key motivating ingredients to our profession by nature!

    D





  • 4.  RE: GUDID Manual Submission

    Posted 01-Sep-2016 03:32

    Dear Belinda,

    We had a similar situation ("initial application submitted in which HL7 SPL was selected and now the decision has been made to manually enter the data") and we filled out the application form again selecting "manual submission" and sent it to GUDID Helpdesk asking them to kindly correct to "manual submission". They answered in less than 2-3 weeks.

    I hope this helps you and wish you good luck!

    Kind Regards,

    Claudia

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    Claudia Meneghisse PHD, RAC
    Senior Regulatory Affairs Manager
    Männedorf
    Switzerland