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href="https://acrpnet.org/renew-membership">Renew Membership</a></li><li class="link-normal"><a href="https://acrpnet.org/membership/chapters-2">Local Chapters</a></li><li class="link-normal"><a href="https://acrpnet.org/about-acrp/volunteer">Volunteer Opportunities</a></li><li class="link-normal"><a href="http://community.acrpnet.org/home">ACRP Community</a></li><li class="link-normal"><a href="https://community.acrpnet.org/browse/network">Member Directory</a></li><li class="link-normal"><a href="https://community.acrpnet.org/communities/community-home?CommunityKey=f550e1c4-7cd4-442e-ac50-1716c56c03b6">Discussion Groups</a></li> </ul> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">Advance Yourself</p> <div class="mega-menu-editor-content"><p>When you become an ACRP member, you’re joining a network with a global reach—and so much more. Our member community of 17,000 clinical research professionals look to us for gold-standard education, rigorous certification, and indispensable connections. </p> <p><a href="https://acrpnet.org/member-benefits">Membership Benefits</a></p> </div> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">Organization Membership</p> <div class="mega-menu-editor-content"><p>For organizations who want to provide their clinical study teams with continuous, ongoing education and professional development resources, Organization Membership is a turnkey and scalable solution.</p> <p><a href="https://acrpnet.org/employer-resources/our-services/acrp-organization-membership/">Organization Membership</a></p> </div> </div></div></li> <li class="menu-item menu-item-type-post_type menu-item-object-mega-menu mega-menu-item mega-menu-item--depth0 mega-menu-item--learning"><a href="https://acrpnet.org/acrp-learning"><span>Learning</span></a><div class="mega-menu-content"><div class="mega-menu-column mega-menu-layout-links span-8"> <p class="mega-menu-title">In this Section</p> <ul> <li class="link-normal"><a href="https://acrpnet.org/training">Course Catalog</a></li><li class="link-normal"><a href="https://acrpnet.org/acrp-learning/how-to-access-your-courses">My Courses</a></li><li class="link-normal"><a href="https://acrpnet.org/acrp-learning/home-study">Home Study</a></li><li class="link-normal"><a href="https://acrpnet.org/competency-domains-clinical-research-professionals">Competency Guidelines</a></li> </ul> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">Popular Training Courses</p> <div class="mega-menu-editor-content"><p><a href="https://acrpnet.org/courses/good-clinical-practice-gcp-simulation/">Good Clinical Practice (GCP) Simulation</a></p> <p><a href="https://acrpnet.org/courses/understanding-clinical-trial-protocols-key-considerations-effective-development-feasibility-review/">Understanding Clinical Trial Protocols<br /> </a></p> <p><a href="https://acrpnet.org/courses/building-quality-management-systems-sites-sponsors-root-cause-capa/">Building Quality Management Systems</a></p> <p><a href="https://acrpnet.org/courses/site-quality-management-tools-sops-metrics-training/">Site Quality Management Tools</a></p> </div> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">Guidelines and Regulations Resource Center</p> <div class="mega-menu-editor-content"><p>ACRP is committed to being a trusted source for all professionals whose roles involve conducting and leading clinical research. Access the most accurate and up-to-date information related to clinical research guidelines and regulations.</p> <p><a href="https://acrpnet.org/insights/guidelines-and-regulations">Explore Resources</a></p> </div> </div></div></li> <li class="menu-item menu-item-type-post_type menu-item-object-mega-menu mega-menu-item mega-menu-item--depth0 mega-menu-item--certification"><a href="https://acrpnet.org/certification"><span>Certification</span></a><div class="mega-menu-content"><div class="mega-menu-column mega-menu-layout-links span-8"> <p class="mega-menu-title">In this Section</p> <ul> <li class="link-normal"><a href="https://acrpnet.org/certification/benefits-of-acrp-certification">Benefits of Certification</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/exam-preparation">Exam Preparation</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/maintain-certification">Maintain Certification</a></li><li class="link-normal"><a href="https://acrpnet.org/about-acrp/the-academy">The Academy</a></li><li class="link-normal"><a href="https://www.avectraacrp.com/eWeb/DynamicPage.aspx?Site=ACRP&WebKey=078ec803-bceb-4265-9ca4-81780725fa6e#_ga=2.24122170.1850992922.1511842942-2105357230.1509637665">Verify ACRP Certification</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/certification-exams-developed">How Certification Exams Are Developed</a></li> </ul> </div><div class="mega-menu-column mega-menu-layout-links span-8"> <p class="mega-menu-title">Our Programs</p> <ul> <li class="link-normal"><a href="https://acrpnet.org/certification/acrp-cp-certification">ACRP-CP® Certification</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/crc-certification">CCRC® Certification</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/cra-certification">CCRA® Certification</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/pi-certification">CPI® Certification</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/acrp-mdp">ACRP-MDP® Specialty</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/acrp-pm">ACRP-PM® Specialty</a></li> </ul> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">ACRP Certification Milestone Achievers</p> <div class="mega-menu-editor-content"><p>ACRP honors the 2023 Certification Milestone Achievers, an exclusive group of nearly 1,700 professionals who have consistently proven their commitment to conducting clinical trials safely, ethically, and to the highest standard.</p> <p><a href="https://acrpnet.org/certifications/certification-milestone/">Learn More</a></p> </div> </div></div></li> <li class="menu-item menu-item-type-post_type menu-item-object-mega-menu mega-menu-item mega-menu-item--depth0 mega-menu-item--careers"><a href="https://acrpnet.org/career-center"><span>Careers</span></a><div class="mega-menu-content"><div class="mega-menu-column mega-menu-layout-links span-8"> <p class="mega-menu-title">In this Section</p> <ul> <li class="link-normal"><a href="https://acrpnet.org/career-center/getting-started-in-clinical-research">Getting Started in Clinical Research</a></li><li class="link-normal"><a href="https://acrpnet.org/competency-domains-clinical-research-professionals">Competency Guides</a></li><li class="link-normal"><a href="https://careers.acrpnet.org/jobs/">Find a Job</a></li><li class="link-normal"><a href="https://careers.acrpnet.org/employer-offers">Post a Job</a></li> </ul> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">Boost Your Prospects with ACRP Certification</p> <div class="mega-menu-editor-content"><p>ACRP Certified professionals say their achievement results in increased job responsibility, more employment and advancement opportunities, and recognition—including promotions, bonuses, and salary increases.</p> <p><a href="https://acrpnet.org/certifications/">Learn More</a></p> </div> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">Getting Started in Clinical Research</p> <div class="mega-menu-editor-content"><p>Interested in a career in clinical research? You’re in the right place! 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Organization Membership</p> <div class="mega-menu-editor-content"><p>For organizations who want to provide their clinical study teams with continuous, ongoing education and professional development resources, Organization Membership is a turnkey and scalable solution.</p> <p><a href="https://acrpnet.org/for-organizations/our-services/acrp-organization-membership/">Learn More</a></p> </div> </div></div></li> </ul></nav> </div> </header> <div class="popup"> <div class="popup_content"> <a href="#" class="close"></a> <h2>ACRP Learning Update</h2> <p>ACRP is happy to announce forthcoming updates to several courses in the ACRP catalog. </p> <a href="https://acrpnet.org/acrp-learning-update" class="button" > Learn More </a> </div> </div> <div class="block-header"> <div class="layout-wrap"> <div class="wrap"> <nav class="breadcrumb"> <ul class="breadcrumb-list"> <li class="breadcrumb-list-item"> <a class="breadcrumb-link" href="https://acrpnet.org/">Home</a> </li> <li class="breadcrumb-list-item"> <a class="breadcrumb-link" href="https://acrpnet.org/insights">Insights</a> </li> <li class="breadcrumb-list-item"> <span class="breadcrumb-active-item">New Informed Consent Expectations Should Aid Participants’ Understanding, May Catch Professionals Off Guard</span> </li> </ul> </nav> <div class="column header-intro"> <p class="block-header-title">Blog</p> </div> </div> </div> </div> <div class="main-container" id="main-content"> <div class="wrap"> <div class="main-content clearfix" style=""> <article id="post-56209" class="post-56209 post type-post status-publish format-standard has-post-thumbnail hentry category-blog" role="article" data-swiftype-name="body" data-swiftype-type="text"> <div class="entry-header clearfix"> <h1 class="entry-title"> New Informed Consent Expectations Should Aid Participants’ Understanding, May Catch Professionals Off Guard </h1> <p class="entry-byline"> <span class="entry-categories"><a href="https://acrpnet.org/news/blog" rel="category tag">Blog</a></span><time class="entry-updated" datetime="2024-11-21T08:47:20-05:00" pubdate>November 21, 2024</time> </p> </div> <div class="entry-image clearfix vertical"> <figure> <img width="250" height="250" src="https://acrpnet.org/wp-content/uploads/2024/11/James-Riddle-ACRP-2025-Blog-250.png" class="attachment-medium size-medium wp-post-image" alt="" decoding="async" srcset="https://acrpnet.org/wp-content/uploads/2024/11/James-Riddle-ACRP-2025-Blog-250.png 250w, https://acrpnet.org/wp-content/uploads/2024/11/James-Riddle-ACRP-2025-Blog-250-200x200.png 200w" sizes="(max-width: 250px) 100vw, 250px" /> <figcaption><p>James Riddle, MCSE, CIP, CPIA, CRQM, Senior Vice President, Global Review Operations, Advarra</p> </figcaption> </figure> </div> <div class="entry-content clearfix" itemprop="articleBody"> <p><span data-contrast="auto">Sometimes in the realm of evolving clinical research regulations, the maxim about “be careful what you wish for” can more accurately be phrased as “be aware of it when you get what you asked for.” Such is the case with </span><a href="https://www.federalregister.gov/documents/2024/03/01/2024-04377/key-information-and-facilitating-understanding-in-informed-consent-draft-guidance-for-sponsors"><span data-contrast="none">recently proposed</span></a><span data-contrast="auto"> U.S. Food and Drug Administration (FDA) guidance updating the agency’s expectations for the contents of informed consent forms for clinical trial participants, says an expert who will explain the history behind the updates and their ramifications for stakeholders at the ACRP 2025 conference in New Orleans in April.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">Noting that the draft guidance on “Key Information and Facilitating Understanding in Informed Consent” for sponsors, investigators, and institutional review boards (IRBs) will likely be finalized by the time he presents on it at the conference, James Riddle, MCSE, CIP, CPIA, CRQM, Senior Vice President, Global Review Operations, at Advarra, says that the big news from the document is that it finally harmonizes certain informed consent practices of the FDA and the Office for Human Research Protections (OHRP). Although this represents a long-anticipated move on the parts of these two branches of the U.S. Department of Health and Human Services, Riddle adds that new expectations framed in the guidance may catch some research professionals off guard, coming as they are in the midst of other, perhaps splashier, regulatory changes that are getting more attention.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">At the heart of the matter is lining up new language about the inclusion of “key information” for trial participants in non-federally funded research (overseen by FDA) found in </span><a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50"><span data-contrast="none">21 CFR Part 50</span></a><span data-contrast="auto"> in the </span><i><span data-contrast="auto">Code of Federal Regulations </span></i><span data-contrast="auto">with the existing language in </span><a href="https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46"><span data-contrast="none">45 CFR Part 46</span></a><span data-contrast="auto"> (the Common Rule) for federally funded research (overseen by OHRP), both labeled as concerning “Protection of Human Subjects.” Riddle says it is important for members of clinical trial teams—and especially for IRBs—to understand what they may or may not need to do in order to prepare their organizations for the change.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">“Since 2019, OHRP guidance includes an expectation of, and instructions for, a concise summary of key information for trial participants that is to be found at the beginning of what can be very long and complicated informed consent forms and written at a reading level that should be understandable to the non-medical expert reader,” Riddle explains. “Among other concerns, the reasonably foreseeable risks and benefits of the research should be articulated in this part of the consent. So most of the large academic medical centers that receive both federal funding and non-federal funding for their clinical trials just adopted the OHRP standards for all of their trials, even though those standards really only apply to the federally funded research,” such as from the National Institutes of Health, the Department of Defense, and so on.</span><span data-ccp-props="{}"> </span></p> <h4 id="yui_3_17_2_1_1732219007978_270" class="eventitem-title"><strong><a href="https://2025.acrpnet.org/2025-program/fdas-latest-guidance-on-informed-consent-reading-between-the-lines">FDA’s Latest Guidance on Informed Consent: Reading Between the Lines</a></strong></h4> <h4><em>Join James at </em><a href="https://2024.acrpnet.org/" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>ACRP 2025</em></a><em> [April 24-27</em><em>; New Orleans, La.</em><em>], where they will break down the new FDA guidance and what it means for accredited Human Research Protection Programs. </em><a href="https://2025.acrpnet.org/schedule" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>View complete schedule</em></a>.</h4> <p><a href="http://2025.acrpnet.org"><img decoding="async" class="wp-image-55457 aligncenter" src="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png" alt="" width="500" height="200" srcset="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png 300w, https://acrpnet.org/wp-content/uploads/2024/01/email2-1024x409.png 1024w, https://acrpnet.org/wp-content/uploads/2024/01/email2-768x307.png 768w, https://acrpnet.org/wp-content/uploads/2024/01/email2.png 1260w" sizes="(max-width: 500px) 100vw, 500px" /></a></p> <p><span data-contrast="auto">When the FDA’s 21 CFR Part 50 did not change along with 45 CFR Part 46, “there was a disconnect between what OHRP and FDA were requiring in terms of the additional elements of informed consent, so even if this key information was included in a consent form for a non-federally funded trial, it was not required,” Riddle says. This key information should help participants to understand the research and encourage them to ask questions about their role in it, he adds.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">The guidance harmonization is part of other regulatory changes that are expected in early 2025 concerning single IRB reviews of proposed research, Riddle explains, so sponsors, contract research organizations, and sites with templates for their informed consents are advised to be ready for making updates as even bigger changes are coming down the pike.</span><span data-ccp-props="{}"> </span></p> <p><i><span data-contrast="auto">Author: Gary Cramer</span></i><span data-ccp-props="{}"> </span></p> <p><a href="https://acrpnet.org/insights/guidelines-and-regulations"><img loading="lazy" decoding="async" class="alignleft wp-image-56070 size-large" src="https://acrpnet.org/wp-content/uploads/2023/11/ICH_728x90-1-1024x127.png" alt="" width="1024" height="127" srcset="https://acrpnet.org/wp-content/uploads/2023/11/ICH_728x90-1-1024x127.png 1024w, https://acrpnet.org/wp-content/uploads/2023/11/ICH_728x90-1-300x37.png 300w, https://acrpnet.org/wp-content/uploads/2023/11/ICH_728x90-1-768x95.png 768w, https://acrpnet.org/wp-content/uploads/2023/11/ICH_728x90-1.png 1456w" sizes="(max-width: 1024px) 100vw, 1024px" /></a></p> <p> </p> <div class="sharethis"> <span class='st_facebook_large' displayText='Facebook'></span> <span class='st_twitter_large' displayText='Tweet'></span> <span class='st_linkedin_large' displayText='LinkedIn'></span> <span class='st_email_large' displayText='Email'></span> <span class='st_sharethis_large' displayText='ShareThis'></span> </div> </div> <div class="entry-footer clearfix"> <p class="entry-tags"> </p> <section class="related-posts"> <h3 class="title-underline">Related</h3> <div class="related-post"> <a 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member, you’re joining a network with a global reach—and so much more. Our member community of 17,000 clinical research professionals look to us for gold-standard education, rigorous certification, and indispensable connections. </p> <p><a href="https://acrpnet.org/member-benefits">Membership Benefits</a></p> </div> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">Organization Membership</p> <div class="mega-menu-editor-content"><p>For organizations who want to provide their clinical study teams with continuous, ongoing education and professional development resources, Organization Membership is a turnkey and scalable solution.</p> <p><a href="https://acrpnet.org/employer-resources/our-services/acrp-organization-membership/">Organization Membership</a></p> </div> </div></div></li> <li class="menu-item menu-item-type-post_type menu-item-object-mega-menu mega-menu-item mega-menu-item--depth0 mega-menu-item--learning"><a href="https://acrpnet.org/acrp-learning"><span>Learning</span></a><div class="mega-menu-content"><div class="mega-menu-column mega-menu-layout-links span-8"> <p class="mega-menu-title">In this Section</p> <ul> <li class="link-normal"><a href="https://acrpnet.org/training">Course Catalog</a></li><li class="link-normal"><a href="https://acrpnet.org/acrp-learning/how-to-access-your-courses">My Courses</a></li><li class="link-normal"><a href="https://acrpnet.org/acrp-learning/home-study">Home Study</a></li><li class="link-normal"><a href="https://acrpnet.org/competency-domains-clinical-research-professionals">Competency Guidelines</a></li> </ul> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">Popular Training Courses</p> <div class="mega-menu-editor-content"><p><a href="https://acrpnet.org/courses/good-clinical-practice-gcp-simulation/">Good Clinical Practice (GCP) Simulation</a></p> <p><a href="https://acrpnet.org/courses/understanding-clinical-trial-protocols-key-considerations-effective-development-feasibility-review/">Understanding Clinical Trial Protocols<br /> </a></p> <p><a href="https://acrpnet.org/courses/building-quality-management-systems-sites-sponsors-root-cause-capa/">Building Quality Management Systems</a></p> <p><a href="https://acrpnet.org/courses/site-quality-management-tools-sops-metrics-training/">Site Quality Management Tools</a></p> </div> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">Guidelines and Regulations Resource Center</p> <div class="mega-menu-editor-content"><p>ACRP is committed to being a trusted source for all professionals whose roles involve conducting and leading clinical research. Access the most accurate and up-to-date information related to clinical research guidelines and regulations.</p> <p><a href="https://acrpnet.org/insights/guidelines-and-regulations">Explore Resources</a></p> </div> </div></div></li> <li class="menu-item menu-item-type-post_type menu-item-object-mega-menu mega-menu-item mega-menu-item--depth0 mega-menu-item--certification"><a href="https://acrpnet.org/certification"><span>Certification</span></a><div class="mega-menu-content"><div class="mega-menu-column mega-menu-layout-links span-8"> <p class="mega-menu-title">In this Section</p> <ul> <li class="link-normal"><a href="https://acrpnet.org/certification/benefits-of-acrp-certification">Benefits of Certification</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/exam-preparation">Exam Preparation</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/maintain-certification">Maintain Certification</a></li><li class="link-normal"><a href="https://acrpnet.org/about-acrp/the-academy">The Academy</a></li><li class="link-normal"><a href="https://www.avectraacrp.com/eWeb/DynamicPage.aspx?Site=ACRP&WebKey=078ec803-bceb-4265-9ca4-81780725fa6e#_ga=2.24122170.1850992922.1511842942-2105357230.1509637665">Verify ACRP Certification</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/certification-exams-developed">How Certification Exams Are Developed</a></li> </ul> </div><div class="mega-menu-column mega-menu-layout-links span-8"> <p class="mega-menu-title">Our Programs</p> <ul> <li class="link-normal"><a href="https://acrpnet.org/certification/acrp-cp-certification">ACRP-CP® Certification</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/crc-certification">CCRC® Certification</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/cra-certification">CCRA® Certification</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/pi-certification">CPI® Certification</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/acrp-mdp">ACRP-MDP® Specialty</a></li><li class="link-normal"><a href="https://acrpnet.org/certification/acrp-pm">ACRP-PM® Specialty</a></li> </ul> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">ACRP Certification Milestone Achievers</p> <div class="mega-menu-editor-content"><p>ACRP honors the 2023 Certification Milestone Achievers, an exclusive group of nearly 1,700 professionals who have consistently proven their commitment to conducting clinical trials safely, ethically, and to the highest standard.</p> <p><a href="https://acrpnet.org/certifications/certification-milestone/">Learn More</a></p> </div> </div></div></li> <li class="menu-item menu-item-type-post_type menu-item-object-mega-menu mega-menu-item mega-menu-item--depth0 mega-menu-item--careers"><a href="https://acrpnet.org/career-center"><span>Careers</span></a><div class="mega-menu-content"><div class="mega-menu-column mega-menu-layout-links span-8"> <p class="mega-menu-title">In this Section</p> <ul> <li class="link-normal"><a href="https://acrpnet.org/career-center/getting-started-in-clinical-research">Getting Started in Clinical Research</a></li><li class="link-normal"><a href="https://acrpnet.org/competency-domains-clinical-research-professionals">Competency Guides</a></li><li class="link-normal"><a href="https://careers.acrpnet.org/jobs/">Find a Job</a></li><li class="link-normal"><a href="https://careers.acrpnet.org/employer-offers">Post a Job</a></li> </ul> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">Boost Your Prospects with ACRP Certification</p> <div class="mega-menu-editor-content"><p>ACRP Certified professionals say their achievement results in increased job responsibility, more employment and advancement opportunities, and recognition—including promotions, bonuses, and salary increases.</p> <p><a href="https://acrpnet.org/certifications/">Learn More</a></p> </div> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">Getting Started in Clinical Research</p> <div class="mega-menu-editor-content"><p>Interested in a career in clinical research? You’re in the right place! Explore career options, resources, and more to help you find your first opportunity in clinical research.</p> <p><a href="https://acrpnet.org/career-center/getting-started-in-clinical-research/">Learn More</a></p> </div> </div></div></li> <li class="menu-item menu-item-type-post_type menu-item-object-mega-menu mega-menu-item mega-menu-item--depth0 mega-menu-item--insights"><a href="https://acrpnet.org/insights"><span>Insights</span></a><div class="mega-menu-content"><div class="mega-menu-column mega-menu-layout-links span-8"> <p class="mega-menu-title">In this Section</p> <ul> <li class="link-normal"><a href="https://acrpnet.org/news/blog">ACRP Blog</a></li><li class="link-normal"><a href="https://acrpnet.org/insights/clinical-researcher">Clinical Researcher</a></li><li class="link-normal"><a href="https://acrpnet.org/news/press-releases/">Press Releases</a></li><li class="link-normal"><a href="https://acrpnet.org/employer-resources/our-services/acrp-partners-advancing-the-clinical-research-workforce/thought-leadership">White Papers & Reports</a></li> </ul> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">Clinical Researcher—October 2024</p> <div class="mega-menu-editor-content"><p><span data-olk-copy-source="MessageBody">As project scopes and protocol complexities continue to grow, trial-related technologies emerge and mature, and new areas of specialization in the clinical research enterprise drive workforce evolution, contributors to this issue invite you to study the theme of “<em>Always be Curious, Never Stop Learning</em>”—focusing on critical facets of ongoing education, training, and research regulation and management so that you can stay ahead of the curve in an ever-changing environment for drug and device development</span>.</p> <p><a href="https://acrpnet.org/insights/clinical-researcher/clinical-researcher-october-2024">Read October 2024 Issue</a></p> <p><a href="https://acrpnet.org/about-acrp/news-events/clinical-researcher/">View Archives</a></p> </div> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">New! DCT Perspectives White Paper</p> <div class="mega-menu-editor-content"><p><a href="https://acrpnet.org/helping-clinical-research-sites-budget-for-decentralized-trial-elements-ensuring-accurate-and-adequate-compensation-for-sites-implementing-dcts/"><img fetchpriority="high" decoding="async" class="alignleft wp-image-54116 size-medium" src="https://acrpnet.org/wp-content/uploads/2018/05/WhitePaper_CoverNav-300x170.png" alt="" width="300" height="170" srcset="https://acrpnet.org/wp-content/uploads/2018/05/WhitePaper_CoverNav-300x170.png 300w, https://acrpnet.org/wp-content/uploads/2018/05/WhitePaper_CoverNav.png 600w" sizes="(max-width: 300px) 100vw, 300px" /></a></p> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <p>This new white paper examines recent work by ACRP and its members to build awareness of the need for a new budget model for sites and to leverage the adoption of DCT elements to improve how sites are supported in their critical contribution to drug development.</p> <p><a href="https://acrpnet.org/helping-clinical-research-sites-budget-for-decentralized-trial-elements-ensuring-accurate-and-adequate-compensation-for-sites-implementing-dcts/">Learn More</a></p> </div> </div></div></li> <li class="menu-item menu-item-type-post_type menu-item-object-mega-menu mega-menu-item mega-menu-item--depth0 mega-menu-item--events"><a href="https://acrpnet.org/events/"><span>Events</span></a><div class="mega-menu-content"><div class="mega-menu-column mega-menu-layout-links span-8"> <p class="mega-menu-title">In this Section</p> <ul> <li class="link-normal"><a href="https://acrpnet.org/events">Events Calendar</a></li><li class="link-normal"><a href="https://2024.acrpnet.org/">ACRP Annual Conference</a></li><li class="link-normal"><a href="https://acrpnet.org/learning/courses/">Webinars</a></li><li class="link-normal"><a href="http://community.acrpnet.org/events/calendar">Chapter Events</a></li><li class="link-normal"><a href="https://www.clinicaltrialsday.org/">Clinical Trials Day</a></li> </ul> </div><div class="mega-menu-column mega-menu-layout-events span-8"> <p class="mega-menu-title">Upcoming Events</p> <ul> <li> <p><a href="https://acrpnet.org/event/colorado-chapter-looking-beyond-dcts-for-the-modernization-of-clinical-research-acrp-2024-conference-replay">Colorado Chapter: Looking Beyond DCTs for the Modernization of Clinical Research (ACRP 2024 Conference Replay)</a></p> <p>December 2, 2024</p> </li> <li> <p><a href="https://acrpnet.org/event/greater-san-diego-2024-holiday-social">Greater San Diego: 2024 Holiday Social</a></p> <p>December 3, 2024</p> </li> <li> <p><a href="https://acrpnet.org/event/western-ny-chapter-a-curious-spectators-observations-ai-and-clinical-trials">Western NY Chapter: A Curious Spectator’s Observations – AI and Clinical Trials</a></p> <p>December 5, 2024</p> </li> </ul> <p><a href="https://acrpnet.org/events/">View All Events</a></p> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">Discounted Rates for ACRP 2025</p> <div class="mega-menu-editor-content"><p>ACRP members save $200 on their ACRP 2025 registration—or $400 when a pre-conference workshop is also selected. With a low membership fee of $160/year, you’ll immediately recoup your investment when you register for the conference.</p> <p><a href="https://acrpnet.org/member-benefits">ACRP Membership</a></p> <p><a href="https://2025.acrpnet.org/registration" target="_blank" rel="noopener">Conference Registration</a></p> </div> </div></div></li> <li class="menu-item menu-item-type-post_type menu-item-object-mega-menu mega-menu-item mega-menu-item--depth0 mega-menu-item--employer-resources"><a href="https://acrpnet.org/employer-resources"><span>Employer Resources</span></a><div class="mega-menu-content"><div class="mega-menu-column mega-menu-layout-links span-8"> <p class="mega-menu-title">In this Section</p> <ul> <li class="link-normal"><a href="https://acrpnet.org/employer-resources">Why ACRP</a></li><li class="link-normal"><a href="https://acrpnet.org/employer-resources/our-services">Our Services</a></li><li class="link-normal"><a href="https://acrpnet.org/employer-resources/our-services/acrp-partners-advancing-the-clinical-research-workforce">Workforce Development</a></li><li class="link-normal"><a href="https://www.avectraacrp.com/eWeb/DynamicPage.aspx?Site=ACRP&WebKey=078ec803-bceb-4265-9ca4-81780725fa6e#_ga=2.24122170.1850992922.1511842942-2105357230.1509637665">Verify ACRP Certification</a></li><li class="link-normal"><a href="https://careers.acrpnet.org/employer-offers">Post a Job</a></li><li class="link-normal"><a href="https://acrpnet.org/employer-resources/our-services/sponsorship-and-advertising-opportunities">Advertising & Sponsorships</a></li> </ul> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">Advancing People Advancing Health™</p> <div class="mega-menu-editor-content"><p>Through our gold-standard education, the most rigorous certification process in the industry, and strong comment connections – ACRP prepares clinical research professionals to be the study team members employers can trust to get it right.</p> <p><a href="https://acrpnet.org/employer-resources/">Learn More</a></p> </div> </div><div class="mega-menu-column mega-menu-layout-editor span-8"> <p class="mega-menu-title">New! Organization Membership</p> <div class="mega-menu-editor-content"><p>For organizations who want to provide their clinical study teams with continuous, ongoing education and professional development resources, Organization Membership is a turnkey and scalable solution.</p> <p><a href="https://acrpnet.org/for-organizations/our-services/acrp-organization-membership/">Learn More</a></p> </div> </div></div></li> </ul></nav> <nav class="nav nav--utility nav--utility-mobile"><ul class="mobile-menu-items"><li class="nav-menu-item nav-menu-item--depth0 menu-item menu-item-type-post_type menu-item-object-page menu-item-49665"><a href="https://acrpnet.org/about-acrp" class="nav-link">About ACRP</a></li> <li class="nav-menu-item nav-menu-item--depth0 nav-highlight menu-item menu-item-type-custom menu-item-object-custom menu-item-18228"><a href="https://member.acrpnet.org/" class="nav-link">My Account</a></li> </ul></nav></div> <section id="wp-footer"> <script> ( function ( body ) { 'use strict'; body.className = body.className.replace( /\btribe-no-js\b/, 'tribe-js' ); } )( document.body ); </script> <script> /* <![CDATA[ */var tribe_l10n_datatables = {"aria":{"sort_ascending":": activate to sort column ascending","sort_descending":": activate to sort column descending"},"length_menu":"Show _MENU_ entries","empty_table":"No data available in table","info":"Showing _START_ to _END_ of _TOTAL_ entries","info_empty":"Showing 0 to 0 of 0 entries","info_filtered":"(filtered from _MAX_ total entries)","zero_records":"No matching records found","search":"Search:","all_selected_text":"All items on this page were selected. 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