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Applied Clinical Trials ; 31(11):24-27, 2022.
Article in English | ProQuest Central | ID: covidwho-20236324

ABSTRACT

[...]countries do not always recognize and allow electronic signatures. In many cases, this calls for a complete revision of existing laws and regulations;it has already been done in the past for some technologies, including the regulation of electronic signatures, but much more important revisions, such as the third revision of International Conference on Harmonization Good Clinical Practice (ICH GCP), are underway for the complete integration of the various aspects of emerging technologies.7 In the scope of our research project, titled "Toward a Global Implementation of eConsent in Clinical Trials," a survey was conducted to understand how eConsent is perceived and experienced by clinical research experts, how it can improve patient comprehension and reduce site burden, as well as to identify areas of opportunities and challenges for further adoption. [...]when stakeholders were asked what the main barrier limiting the implementation of eConsent at their organization is, many sponsors explained that the fragmented guidelines and regulations had considerably hindered their use of eConsent. [...]it requires staff training and adaptation and, here again, the fragmented or-in some cases-even lack of regulation around eConsent makes it difficult to implement on sites.

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