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Thread: Verification of consent process

  1. #1
    Forum Member
    Join Date
    Jan 2015

    Verification of consent process

    Hello all,

    In a study with healthy volunteers, I was wondering how it is possible for a monitor to verify the consent process was carried out appropriately? The only information that the team record is date the information sheet was sent out to volunteers (who contacted the team to express their interest in taking part). The team does not routinely make entries into volunteer's medical notes and as they are healthy volunteers, some do not have medical notes.

    Thank you in advance for any advice.


  2. #2
    Forum Member
    Join Date
    Sep 2012
    Assuming that medical notes would be set up for the participant at the point they consent for the study, then you could train the site staff to retrospectively document the consent process at that time point, and make it clear that it was written retrospectivey and why. You could also provide a screening checklist to be completed by the site staff to capture details of the consent process - i.e. date info sheet provided, what version was provided, any discussions regarding the study (in person or by telephone), date that consent was signed, version of consent form used. The screening checklist (signed and dated by site staff) would then be the Monitor's source data for the consent process.

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