{"id":40126,"date":"2021-10-08T12:09:39","date_gmt":"2021-10-08T19:09:39","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=40126"},"modified":"2026-05-28T13:28:25","modified_gmt":"2026-05-28T20:28:25","slug":"econsent","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/econsent\/","title":{"rendered":"91爆料 E-Consent Tools"},"content":{"rendered":"
This webpage provides instructions to researchers intending to use 91爆料 eSignatures (powered by Docusign), 91爆料 Florence eConsent, 91爆料 Medicine Research Information Technologies (RIT) REDCap Part 11,\u00a0 or 91爆料 ITHS REDCap e-consent tools. The 91爆料 IRB may be able to approve other electronic consent tools or methods. For full details, review the section on Approvable methods for obtaining electronic signatures<\/a> in HSD’s consent guidance.<\/p>\n eSignatures (powered by Docusign) is an electronic signatures service provider, centrally managed and supported by 91爆料-IT.<\/p>\n Conditions for using eSignatures<\/strong>:<\/p>\n Visit eSignatures<\/a> for additional information about this service. Explore the Docusign Support<\/a> website and watch this brief, 1-minute video overview: How It Works<\/a>.<\/p>\n 91爆料 Florence eConsent is an electronic consent tool maintained by the 91爆料 Clinical Trials Office (CTO) that meets FDA 21 CFR Part 11 requirements for FDA regulated research. You can save all signed forms from 91爆料 Florence eConsent to your study\u2019s regulatory binder or download them to your computer.<\/p>\n Conditions for using 91爆料 Florence eConsent<\/strong>:<\/p>\n For more information, visit the 91爆料 CTO Florence website<\/a> or email 91爆料 CTO at uwcto@uw.edu<\/a> with 91爆料 Florence eConsent in the subject line.<\/p>\n <\/p>\n The\u00a091爆料 ITHS version of REDCap, accessed via a web browser on any device, <\/strong>can be configured to capture legally valid electronic signatures on consent forms and HIPAA authorization forms when the appropriate electronic consent templates and project settings are used.<\/p>\n The REDCap Mobile application does not<\/strong> support the same secure set-up and records retention requirements. It is a separate software application for use with a mobile device when internet service is absent or unreliable. Electronic signatures obtained with REDCap Mobile are not considered legally valid under federal and Washington State law, so REDCap Mobile may only be used when the IRB has granted a waiver of documentation of informed consent.<\/p>\n Conditions for using REDCap<\/strong>:<\/p>\n 91爆料 Medicine RIT\u2019s validated REDCap Part 11 instance is jointly managed by 91爆料 Research IT and 91爆料 Medicine Information Technology Services and is intended for use with FDA-regulated research<\/a>. It is designed to support electronic records and signatures in accordance with FDA\u2019s 21 CFR Part 11 requirements.<\/p>\n Conditions for using 91爆料 Medicine RIT REDCap Part 11<\/strong>:<\/p>\n <\/p>\n Some studies may be required to use a REDCap system operated by another institution or wish to use a 91爆料-managed REDCap installation that is not 91爆料 ITHS REDCap or 91爆料 Medicine RIT REDCap Part 11.<\/p>\n In these cases, research teams must complete the Other REDCap Installation Supplement. Data collection and electronic signatures may not begin in the other REDCap system until the supplement has been reviewed and approved by the 91爆料 IRB or, for studies under external IRB review, by HSD.<\/p>\n <\/p>\n <\/p>\nContents<\/h3>\n
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Using 91爆料 eSignatures (powered by Docusign)<\/h3>\n
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Using 91爆料 Florence eConsent<\/h3>\n
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Using 91爆料 ITHS REDCap<\/h3>\n
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Using 91爆料 Medicine RIT REDCap Part 11<\/h3>\n
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Using a Non-91爆料 or Other 91爆料-managed REDCap Installation (Excluding 91爆料 ITHS REDCap and 91爆料 Medicine RIT REDCap Part 11) <\/strong><\/h3>\n