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Thread: Sending Consent Forms to a Coordinating Centre

  1. #1

    Sending Consent Forms to a Coordinating Centre

    We are increasingly being asked to send copies of consent forms to coordinating centres for central monitoring purposes. Does any one have any advice on whether this is acceptable? In some instances the REC application doesn't mention that this will be happening and neither does the monitoring plan.
    Is it sufficient that the consent form says something along the lines of 'data collected during the study may be looked at by individuals from the research team, from regulatory authorities or from the NHS Trust, where it is relevant to my taking part in this research' or should the PIS specifically say that consent forms will be faxed to the coordinating centre?
    Appreciate any advice - thank you

  2. #2
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    Unhappy Central monitoring versus on site montoring

    Quote Originally Posted by celestinehhousel View Post
    We are increasingly being asked to send copies of consent forms to coordinating centres for central monitoring purposes. Does any one have any advice on whether this is acceptable? In some instances the REC application doesn't mention that this will be happening and neither does the monitoring plan.
    Is it sufficient that the consent form says something along the lines of 'data collected during the study may be looked at by individuals from the research team, from regulatory authorities or from the NHS Trust, where it is relevant to my taking part in this research' or should the PIS specifically say that consent forms will be faxed to the coordinating centre?
    Appreciate any advice - thank you
    This interessting topic. I'm not sure i'm understanding the context here.
    - Monitoring is part of the sponsor responsabilities : Monitor are asked to check ICF during On site visit monitoring
    -ICF should not go outside the Investigator site to make sure confidentiality of information is fully maintained with the Site Staff authorised to see it
    - Central monitoring should only apply when it's possible via electonic systems (e-Consent) however, if we are in paper process, there is not option for central monitoring to fax confidential information outside the site and it's not possible for you to make sure that the Fax/eFax is destoroyed after monitoring ? There should be risk analysis perfomed for this practice as there potentiel Serious breach of patient right then a SOP with the full process and the control/mitigation action regarding any risk of data privacy breach.

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