{"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":"糖心少女E-Consent Tools"},"content":{"rendered":"<p>This webpage provides instructions to researchers intending to use 糖心少女eSignatures (powered by Docusign), 糖心少女Florence eConsent, 糖心少女Medicine Research Information Technologies (RIT) REDCap Part 11,\u00a0 or 糖心少女ITHS REDCap e-consent tools. The 糖心少女IRB may be able to approve other electronic consent tools or methods. For full details, review the section on <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/#10e\">Approvable methods for obtaining electronic signatures<\/a> in HSD&#8217;s consent guidance.<\/p>\n<div class=\"table-of-contents\">\n<h3 id=\"toc\">Contents<\/h3>\n<ul class=\"list-unstyled\">\n<li><a href=\"#docusign\">Using 糖心少女eSignatures (powered by Docusign)<\/a><\/li>\n<li><a href=\"#florence\">Using 糖心少女Florence eConsent<\/a><\/li>\n<li><a href=\"#redcap\">Using 糖心少女ITHS REDCap<\/a><\/li>\n<li><a href=\"#redcappart11\">Using 糖心少女Medicine RIT REDCap Part 11<\/a><\/li>\n<li><a href=\"#otherredcap\">Using a Non-糖心少女or other UW-managed REDCap installation (excluding 糖心少女ITHS REDCap and 糖心少女Medicine RIT REDCap Part 11)<\/a><\/li>\n<li><a href=\"#tutorial\">E-consent tutorial<\/a><\/li>\n<\/ul>\n<\/div>\n<h3 id=\"docusign\">Using 糖心少女eSignatures (powered by Docusign)<\/h3>\n<p>eSignatures (powered by Docusign) is an electronic signatures service provider, centrally managed and supported by UW-IT.<\/p>\n<p><strong>Conditions for using eSignatures<\/strong>:<\/p>\n<ul>\n<li>All applicable <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/#econsentrequirements\">requirements for electronic consent documentation<\/a> must be met.<\/li>\n<li>Docusign cannot be used with any FDA-regulated study because it does not meet the FDA&#8217;s 21 CFR Part 11 electronic system requirements.<\/li>\n<li>Approval to use eSignatures for electronic consent and\/or HIPAA authorization signatures must be obtained from:\n<ul>\n<li><strong>糖心少女IRB<\/strong>, for UW-reviewed studies, or<\/li>\n<li><strong>the external IRB and HSD<\/strong>, for studies under external IRB review.<\/li>\n<\/ul>\n<\/li>\n<li>After obtaining IRB approval to use it, the PI or study lead can request a Docusign &#8220;Sender&#8221; account from their Docusign Delegated Administrator.\n<ul>\n<li>If you are unable to identify your department\u2019s delegated administrator, reach out to the eSignatures support team using the\u00a0<a href=\"https:\/\/uw.service-now.com\/sp?id=sc_cat_item&amp;sys_id=916c087f1b3b9114cc990dc0604bcb44\">Get help with eSignatures (Docusign)<\/a>\u00a0form.<\/li>\n<\/ul>\n<\/li>\n<li>Signed consent forms must be promptly downloaded from Docusign by the PI or study team. Docusign is not a storage solution.<\/li>\n<\/ul>\n<p>Visit <a href=\"https:\/\/uwconnect.uw.edu\/it?id=kb_article_view&amp;sysparm_article=KB0033942\">eSignatures<\/a> for additional information about this service. Explore the <a href=\"https:\/\/support.docusign.com\/s\/?language=en_US\">Docusign Support<\/a> website and watch this brief, 1-minute video overview: <a href=\"https:\/\/www.docusign.com\/resources\/videos\/product\/how-it-works\">How It Works<\/a>.<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h3 id=\"florence\">Using 糖心少女Florence eConsent<\/h3>\n<p>糖心少女Florence eConsent is an electronic consent tool maintained by the 糖心少女Clinical Trials Office (CTO) that meets FDA 21 CFR Part 11 requirements for FDA regulated research. You can save all signed forms from 糖心少女Florence eConsent to your study\u2019s regulatory binder or download them to your computer.<\/p>\n<p><strong>Conditions for using 糖心少女Florence eConsent<\/strong>:<\/p>\n<ul>\n<li>All applicable <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/#10e\">requirements for electronic consent documentation<\/a> must be met.<\/li>\n<li>Approval to use 糖心少女Florence eConsent for electronic consent and\/or HIPAA authorization signatures must be obtained from:\n<ul>\n<li><strong>糖心少女IRB<\/strong>, for UW-reviewed studies, or<\/li>\n<li><strong>the external IRB and HSD<\/strong>, for studies under external IRB review.<\/li>\n<\/ul>\n<\/li>\n<li>Use of 糖心少女Florence eConsent requires:\n<ul>\n<li>A one-time fee for industry-sponsored-and-initiated studies only. Study teams are advised to wait until contracts are finalized and IRB approval is granted before requesting setup for fee-incurring studies.<\/li>\n<li>Required training for all study team members who will access the system, provided by Florence.<\/li>\n<li>Study participants to authenticate their identity using an email-based account. Study teams may need to guide participants through the account creation process.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>For more information, visit the <a href=\"https:\/\/clinicaltrials.uwmedicine.org\/electronic-regulatory-documents-management-uw-florence\/#Florence-eConsent\">糖心少女CTO Florence website<\/a> or email 糖心少女CTO at <a href=\"mailto:uwcto@uw.edu\">uwcto@uw.edu<\/a> with 糖心少女Florence eConsent in the subject line.<\/p>\n<p>&nbsp;<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h3 id=\"redcap\">Using 糖心少女ITHS REDCap<\/h3>\n<p>The\u00a0<strong>糖心少女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<p>The REDCap Mobile application does <strong>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<p><strong>Conditions for using REDCap<\/strong>:<\/p>\n<ul>\n<li>All applicable <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/#10e\">requirements for electronic consent documentation<\/a> must be met.<\/li>\n<li>Approval to use REDCap for electronic consent and\/or HIPAA authorization signatures must be obtained from:\n<ul>\n<li><strong>糖心少女IRB<\/strong>, for UW-reviewed studies, or<\/li>\n<li><strong>the external IRB and HSD<\/strong>, for studies under external IRB review.<\/li>\n<\/ul>\n<\/li>\n<li>The\u00a0<strong>糖心少女ITHS version of REDCap<\/strong>\u00a0cannot be used with any FDA-regulated study because it does not meet the FDA\u2019s Part 11 electronic system requirements.<\/li>\n<li>The REDCap consent \u201csurvey\u201d (the term used for consent forms in REDCap) must be set up for the individual project using one of the ITHS REDCap e-consent templates. Review the ITHS online tutorial <a href=\"https:\/\/www.iths.org\/investigators\/services\/bmi\/redcap\/curriculum\/rc-307\/\">Using REDCap for E-Consent<\/a> for details.<\/li>\n<li>The signed consent form must be retained in REDCap on the REDCap server. REDCap will automatically store the consents so long as no records or the project itself are deleted. The researcher is responsible for ensuring the signed consent forms are retained for the appropriate record retention period.<\/li>\n<\/ul>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<div style=\"text-align: left;\" align=\"right\">\n<h3 id=\"redcappart11\">Using 糖心少女Medicine RIT REDCap Part 11<\/h3>\n<p>糖心少女Medicine RIT\u2019s validated REDCap Part 11 instance is jointly managed by 糖心少女Research IT and 糖心少女Medicine Information Technology Services and is intended for use with <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/fda\/#3\">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<p><strong>Conditions for using 糖心少女Medicine RIT REDCap Part 11<\/strong>:<\/p>\n<ul>\n<li>All applicable requirements for electronic consent documentation must be met.<\/li>\n<li>Approval to use REDCap for electronic consent and\/or HIPAA authorization signatures must be obtained from:\n<ul>\n<li><strong>糖心少女IRB<\/strong>, for UW-reviewed studies, or<\/li>\n<li><strong>the external IRB and HSD<\/strong>, for studies under external IRB review.<\/li>\n<\/ul>\n<\/li>\n<li><strong>糖心少女REDCap Part 11 <\/strong>is intended for use with research that must meet 21 CFR Part 11 requirements. As outlined on the <a href=\"https:\/\/rit.uw.edu\/redcap-part-11\/\">糖心少女REDCap Part 11 webpage<\/a>, use of 糖心少女REDCap Part 11 requires:\n<ul>\n<li>Payment of a project specific service fee,<\/li>\n<li>Completion of mandatory REDCap Part 11 training that covers appropriate user management, record locking, and other elements that are required for compliance with FDA 21 CFR Part 11, and<\/li>\n<li>Project-specific validation<\/li>\n<\/ul>\n<\/li>\n<li>The REDCap consent \u201csurvey\u201d (the term used for consent forms in REDCap) must be set up for the individual project using one of the REDCap e-consent templates. Review ITHS online tutorial <a href=\"https:\/\/www.iths.org\/investigators\/services\/bmi\/redcap\/curriculum\/rc-307\/\">Using REDCap for E-Consent<\/a> for details.<\/li>\n<li>The signed consent form must be retained in REDCap on the REDCap server. REDCap will automatically store the consents so long as no records or the project itself are deleted. The researcher is responsible for ensuring the signed consent forms are retained for the appropriate record retention period.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<\/div>\n<h3 id=\"otherredcap\"><strong>Using a Non-糖心少女or Other UW-managed REDCap Installation (Excluding 糖心少女ITHS REDCap and 糖心少女Medicine RIT REDCap Part 11) <\/strong><\/h3>\n<p>Some studies may be required to use a REDCap system operated by another institution or wish to use a UW-managed REDCap installation that is not 糖心少女ITHS REDCap or 糖心少女Medicine RIT REDCap Part 11.<\/p>\n<p>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 糖心少女IRB or, for studies under external IRB review, by HSD.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h3 id=\"tutorial\">E-consent tutorial<\/h3>\n<p>This short, interactive tutorial provides a quick overview of electronic consent &#8211; <a href=\"https:\/\/www.washington.edu\/research\/learning\/online\/index.php\/lessons\/electronic-consent-what-you-need-to-know\/\">Electronic Consent: What you need to know<\/a>.<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"14\">Version Information<\/h2>\n<p>Open the accordion below for version changes to this guidance.<\/p>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Version History<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<table>\n<tbody>\n<tr>\n<th style=\"background-color: #4b2e83; color: #ffffff; text-align: center;\">Version Number<\/th>\n<th style=\"background-color: #4b2e83; color: #ffffff; text-align: center;\">Posted Date<\/th>\n<th style=\"background-color: #4b2e83; color: #ffffff; text-align: center;\">Implementation Date<\/th>\n<th style=\"background-color: #4b2e83; color: #ffffff; text-align: center;\">Change Notes<\/th>\n<\/tr>\n<tr>\n<td>1.7<\/td>\n<td>04.02.2026<\/td>\n<td>04.02.2026<\/td>\n<td>Added information about 糖心少女Medicine RIT REDCap Part 11 and 糖心少女Florence eConsent, updates to Docusign and ITHS REDCap sections, updated page name to 糖心少女E-Consent Tools<\/td>\n<\/tr>\n<tr>\n<td>1.6<\/td>\n<td>10.30.2025<\/td>\n<td>10.30.2025<\/td>\n<td>Updates to Docusign section; clarification of requirements that are specific to electronic consent documentation<\/td>\n<\/tr>\n<tr>\n<td>1.5<\/td>\n<td>06.26.2025<\/td>\n<td>06.26.2025<\/td>\n<td>Remove note about 糖心少女DocuSign and 糖心少女ITHS RedCap being the only two acceptable methods of obtaining e-signatures for HIPAA authorization to access PHI held by 糖心少女Medicine and Seattle Children\u2019s<\/td>\n<\/tr>\n<tr>\n<td>1.4<\/td>\n<td>03.27.2025<\/td>\n<td>03.27.2025<\/td>\n<td>Revise FDA Part 11 compliance statement to note that 糖心少女ITHS REDCap is not compliant<\/td>\n<\/tr>\n<tr>\n<td>1.3<\/td>\n<td>12.23.2024<\/td>\n<td>12.23.2024<\/td>\n<td>Update FDA Part 11 compliance statement for 糖心少女ITHS REDCap<\/td>\n<\/tr>\n<tr>\n<td>1.2<\/td>\n<td>08.31.2023<\/td>\n<td>08.31.2023<\/td>\n<td>Remove requirement to provide IRB Approval or External Authorization letter to use DocuSign<\/td>\n<\/tr>\n<tr>\n<td>1.1<\/td>\n<td>12.29.2022<\/td>\n<td>12.29.2022<\/td>\n<td>Retitle from GUIDANCE Electronic Consent Signatures; clarify that the document is actually instructions for using 糖心少女e-signature tools<\/td>\n<\/tr>\n<tr>\n<td>1.0<\/td>\n<td>10.08.2021<\/td>\n<td>10.08.2021<\/td>\n<td>Newly published guidance page<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/div>\n<p>Keywords: Consent<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This webpage provides instructions to researchers intending to use 糖心少女eSignatures (powered by Docusign), 糖心少女Florence eConsent, 糖心少女Medicine Research Information Technologies (RIT) REDCap Part 11,\u00a0&#8230;<\/p>\n","protected":false},"author":15,"featured_media":0,"parent":40124,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-units-small-hero.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-40126","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - 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