Allison Grosik

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  • in reply to: List of Research Grants and Fellowship Awards in CVs #3566
    Allison Grosik
    Participant

    I have not seen Sponsors require other company names or study titles to be redacted from site personnel CVs. In my opinion, if the CV includes study information that is already present on Clinicaltrials.gov, it should not be an issue. I agree with Eldin to check the CDA for specific language.

    Best regards,
    Allison Grosik
    LMK Clinical Research Consulting

    in reply to: Health Authority Submissions Made by CROs #3518
    Allison Grosik
    Participant

    Hi Dee,

    From my experience, Health Authority submission documents generated by the CRO (e.g. CTAs, substantial amendment notification forms, cover letters, etc)
    are filed in the study eTMF. CROs usually do not have access to file directly into the Sponsor regulatory system.

    I have seen Sponsors file regulatory documents directly in their internal system for only those countries where they hold submission responsibility. This is common for USA FDA.

    Best regards,
    Allison Grosik
    LMK Clinical Research Consulting

    in reply to: eTMF system- Filing document in the correct Zone. #3013
    Allison Grosik
    Participant

    Janna- I agree with filing the ‘Site Activation Checklist’ to 05.02.17 IP Site Documentation.

    In regards to your filing question on the ‘Certification of Clinical Study’, it sounds to me to be either an Ethics Committee or Regulatory Authority Approval.​ I recommend filing either to 04.01.02 IRB/IEC Approval or 03.01.02 Regulatory Authority Decision dependent on the approval body.

    Best regards,
    Allison Grosik
    LMK Clinical Research Consulting

    in reply to: eTMF system- Filing document in the correct Zone. #2937
    Allison Grosik
    Participant

    Hi Janna,

    I commonly see Site Activation Letters filed in 05.02.17 IP Site Release Documentation.

    I hope this helps!

    Best regards,
    Allison

Viewing 4 posts - 1 through 4 (of 4 total)