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There were several key features that were not readily apparent in other systems at the time we developed our program. Firstly, none of these web-based systems were specifically designed to handle studies with more than minimal consent, which would allow for a waiver of the signing of an informed consent document. To date, the DHHS has not yet allowed electronic signatures for informed consent for research studies, even though this is an accepted practice in business and finance. Genetic studies are âby definitionâ considered as greater than minimal risk and thus we needed a process that would allow for an interactive, yet confidential informed consent process, incorporating a signatory process that would reduce the possibility of fraudulent identity. Secondly we needed a branched logic questionnaire design that would allow for easy and rapid completion by participants. Thirdly, we needed an integrated HIPAA-compliant portal to allow for ease of communication. Finally we needed a process by which clinical information, particularly digital imaging studies, could be easily and securely transmitted to our research system, appropriately tracked and managed
Maria Carolina Ortube: A Novel Web-Based Clinical Research Tool for a Nationwide Research Study
Last date updated on June, 2014