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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?
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