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e-Consent

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  • solution
    08/07/2016 14:59
    Is it appropriate to use an e-solution to manage the consent of subjects which enters the subject name and signature which is stored on a central server by a Sponsors CRO. What are the requirements to store this information at each investigator site? If accessibility is set up per site which is managed separately from the Sponsor appropriate?
  • GCP Com
    08/07/2016 18:57
    There is a very good Q & A on "Electronic Consent" on the RQA GCP webpages (Ref: PH03 Date: 23rd February 2011 (MHRA Approved)) Although written in 2011 there is much of value. >>> Obviously subjects name and signature would, at all times, be under the control of the investigator/institution. Personal information would be NOT be stored on the sponsor (or sponsors agent, such as a CRO) servers. Requirements would be the same as those for paper consent forms. They should be maintained securely ensuring the privacy and confidentiality of subjects. >> The computing committee will provide information on relevant computer information
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