Karen Roy

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Viewing 6 posts - 1 through 6 (of 6 total)
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  • in reply to: What Type of Documents Need to be Certified When eFiling? #4066
    Karen Roy
    Participant

    Hi Janet
    The regulations state that if you have paper originated documents that you destroy, the copies should be certified. If you have the files electronically, you could use these and not scan and certify, but I would personally assess the effort of just scanning all the documents from paper (certified process) versus scanning some and finding some electronic and filing the electronic ones in between the scanned paper documents!
    In addition, you need to be sure that the electronic documents have not been changed over the years.
    Karen

    in reply to: correspondence #4062
    Karen Roy
    Participant

    Hi Mariz. If you look under resources you will find an email communication guide and webinar recording – these will help!
    Karen

    in reply to: Working with a CRO who won’t file ‘outside’ documents #3900
    Karen Roy
    Participant

    Hi Katie

    There are a number of slides that the MHRA have presented that support that section 8 is not sufficient. They may help – email me and I can send them. kroy@phlexglobal.com

    Karen

    Karen Roy
    Participant

    Hi Janna

    Can I advise that you look at TMF RM 3.2 with the new set of sub-artifacts? This will assiste with where to file documents.

    Karen

    in reply to: Sponsor versus Third Party #3666
    Karen Roy
    Participant

    Hi
    Assuming there is still a Sponsor funding the project, I would put the CVs in Zone 9. If the CRO is also the Sponsor, then Zone 1.
    Karen

    in reply to: Electronic TMF #2723
    Karen Roy
    Participant

    Hi Michelle
    The best thing is to talk to people who have moved to an eTMF already. Many people have presented at conferences. I’m sure people will offer on here! Feel free to email me and I can send on any presentations I can find kroy@phlexglobal.com.
    Karen

Viewing 6 posts - 1 through 6 (of 6 total)