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class="menu-item menu-item-type-post_type menu-item-object-mega-menu mega-menu-item mega-menu-item--depth0 mega-menu-item--membership"><a href="https://acrpnet.org/membership"><span>Membership</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/member-benefits">Member Benefits</a></li><li class="link-normal"><a 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! 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> </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">Guidelines and Regulations Resource Center</span> </li> </ul> </nav> <div class="column header-intro"> <h1 class="block-header-title">Guidelines and Regulations Resource Center</h1> </div> <div class="column header-featured header-featured-links-col"> </div> </div> </div> </div> <div class="flex-layouts" data-swiftype-name="body" data-swiftype-type="text"> <section id="flex-layout-0" class="flex-layout flex-layout-columns flex-layout-padding-none flex-layout-padding-xlarge flex-layout-mobile-single flex-layout-max-width-xlarge" data-layout="columns"> <div class="layout-wrap"><div class="wrap"> <div class="column span-16 column-padding-medium"> <h2>ACRP is committed to being your trusted source for the most accurate and up-to-date information related to clinical research guidelines and regulations.</h2> <p>A list of Authorities and Organizations with the most relevant resources are noted below. This Resource Center is designed to support the awareness and education of all professionals whose roles involve conducting and leading clinical research.</p> <p><strong>International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)</strong></p> <h4>The following ICH guidelines are commonly referenced in ACRP educational resources and ACRP Certification Exams.</h4> <ul> <li>ICH E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting</li> <li>ICH E6 – Good Clinical Practice</li> <li>ICH E8 – General Considerations for Clinical Trials</li> <li>ICH E9 – Statistical Principles for Clinical Trials</li> <li>ICH E11 – Clinical Trials in Pediatric Population</li> </ul> <p><a href="https://www.ich.org/page/efficacy-guidelines" target="_blank" rel="noopener">Explore ICH Guidelines ></a></p> <p><strong>U.S. Food & Drug Administration (FDA) Guidance Documents</strong></p> <h4>The <a href="https://www.fda.gov/" target="_blank" rel="noopener">FDA website</a> lists all official FDA Guidance Documents and Code of Federal Regulations (CFR). The hyperlinks below provide direct access to the some of the most relevant U.S. FDA resources.</h4> <ul> <li><a href="https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/clinical-trials-guidance-documents" target="_blank" rel="noopener">Clinical Trials Guidance Documents</a></li> <li><a href="https://www.fda.gov/drugs" target="_blank" rel="noopener">The Center for Drug Evaluation and Research (CDER)</a></li> <li><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/search-general-and-cross-cutting-topics-guidance-documents" target="_blank" rel="noopener">General and Cross-Cutting Topics</a></li> <li><a href="https://www.fda.gov/drugs/guidances-drugs/guidance-snapshot-pilot" target="_blank" rel="noopener">Guidance Snapshots at a Glance</a></li> </ul> <p><strong>The International Organization for Standardization (ISO)</strong></p> <h4>The ISO is a worldwide federation of national standards bodies. This document addresses good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.</h4> <ul> <li><a href="https://www.iso.org/obp/ui/#iso:std:iso:14155:ed-3:v1:en" target="_blank" rel="noopener">Clinical Investigation of Medical Devices for Human Subjects</a></li> </ul> <p><strong>The U.S. Department of Health & Human Services (HHS)</strong></p> <h4>The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).</h4> <ul> <li>OHRP’s Compliance Oversight</li> <li>Common Rule</li> <li>Key Information and Facilitating Understanding in Informed Consent</li> <li>Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions</li> <li>Research Involving Children as Subjects and not otherwise approval by an Institutional Review Board</li> <li>Use of Single Institutional Review Board for Cooperative Research</li> </ul> <p><a href="https://www.hhs.gov/ohrp/index.html">Explore These Resources on the OHRP Website ></a></p> <p><strong>World Medical Association (WMA)</strong></p> <h4>The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.</h4> <p><a href="https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/" target="_blank" rel="noopener">Read Declaration of Helsinki ></a></p> <h2>ACRP Resources</h2> <ul> <li>Implications of Forthcoming ICH GCP E6(R3) Updates Expected Throughout Organizations: Time to Prepare (Blog) <a href="https://acrpnet.org/2024/11/13/implications-of-forthcoming-ich-gcp-e6r3-updates-expected-throughout-organizations-time-to-prepare" target="_blank" rel="noopener">Read ></a></li> <li>Good Clinical Practice (GCP) Simulation (Interactive training program) <a href="https://acrpnet.org/learning/courses/good-clinical-practice-gcp-simulation" target="_blank" rel="noopener">Enrollment Options ></a></li> <li>Industry Guidance Spreadsheet (A curated list of common FDA Guidance Documents with hyperlinks) <a href="https://acrpnet.org/wp-content/uploads/2024/10/ACRP-Industry-Guidance-Spreadsheet-10.09.24.pdf" target="_blank" rel="noopener">Download ></a></li> <li>Investigator Responsibilities (On-demand training program) <a href="https://acrpnet.org/learning/courses/investigator-responsibilities" target="_blank" rel="noopener">Enrollment Options ></a></li> <li>Facilitating Understanding in Informed Consent (Webinar replay) <a href="https://acrpnet.org/learning/courses/facilitating-understanding-in-informed-consent" target="_blank" rel="noopener">Enrollment Options ></a></li> </ul> <h4>The ACRP ICH E6(R3) Working Group is a volunteer group of subject matter experts who are committed to preparing for—and revising ACRP training courses to reflect—the updated guidance according to the ICH E6(R3) Good Clinical Practice Guideline. ACRP will communicate its plans and the impact of these anticipated changes on our training and education coursework on this page so please check back often.</h4> <h2>ACRP 2025</h2> <h4><img loading="lazy" decoding="async" class="alignleft wp-image-55800 size-medium" src="https://acrpnet.org/wp-content/uploads/2024/10/ACRP25_Mark_Geaux_blackblue-300x151.png" alt="" width="300" height="151" />As part of ACRP’s commitment to preparing for the ICH E6(R3) Good Clinical Practice Guidelines changes, we have assembled 17 sessions related to guidance and regulations across the agenda at ACRP 2025, Thursday, April 24 – Sunday, April 27, New Orleans.</h4> <h4><a href="https://2025.acrpnet.org/lets-talk-guidance" target="_blank" rel="noopener">Explore the ‘Let’s Talk Guidance’ curated sessions ></a></h4> <p> </p> <p><strong>ACRP 2025 “Let’s Talk Guidance” Session Blog</strong></p> <ul> <li><a href="https://acrpnet.org/2024/11/21/new-informed-consent-expectations-should-aid-participants-understanding-may-catch-professionals-off-guard" target="_blank" rel="noopener">New Informed Consent Expectations Should Aid Participants’ Understanding, May Catch Professionals Off Guard</a></li> </ul> </div> <div class="column span-8 column-padding-medium"> <h4>WELCOME TO THE RESOURCE CENTER</h4> <p><iframe loading="lazy" title="Bridget Gonzales, CCRC, Welcomes You to the ACRP Guidelines and Regulations Resource Center" src="https://player.vimeo.com/video/1017997770?dnt=1&app_id=122963" width="500" height="281" frameborder="0" allow="autoplay; fullscreen; picture-in-picture; clipboard-write"></iframe></p> <h4>Bridget Gonzales, Head of ACRP Educational Programs, provides a brief overview of the resource center and shares what to expect from ACRP as we prepare for the coming changes in the ICH E6(R3) Good Clinical Practice Guidelines.</h4> <h4>ACRP ICH E6(R3) Working Group members will prepare webinars, blogs, articles, and handouts to clarify the changes. More details and the links to enroll will be posted here when available.</h4> <p> </p> <p><a href="https://community.acrpnet.org/discussion/acrp-guidelines-and-regulations-resources-center#bma736eb35-34c0-4144-955a-65caf3d57d1e"><img loading="lazy" decoding="async" class="aligncenter wp-image-55679 size-full" src="https://acrpnet.org/wp-content/uploads/2024/10/300x250_ICHE6-1-e1728998973642.png" alt="" width="300" height="250" /></a></p> <h4>Have a question about the guideline changes? Want to see what ACRP members are reporting? <a href="https://community.acrpnet.org/discussion/acrp-guidelines-and-regulations-resources-center#bma736eb35-34c0-4144-955a-65caf3d57d1e" target="_blank" rel="noopener">Login to the Discussion Forum ></a><br /> Not an ACRP member? <a href="https://acrpnet.org/membership" target="_blank" rel="noopener">Join Today!</a></h4> </div> </div></div> </section> <section id="flex-layout-1" class="flex-layout flex-layout-accordion flex-layout-padding-small flex-layout-padding-xlarge flex-layout-max-width-xlarge" data-layout="accordion"> <div class="layout-wrap"><div class="wrap"><div class="column content"> <div class="accordion-panel"> <h3 class="accordion-panel-title"> <a href="#resource-center-faqs"> <i class="svg svg--remove" data-icon="remove"> <svg role="img" version="1.1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="24" height="24" viewBox="0 0 24 24"> <path fill="#444" d="M18.984 12.984h-13.969v-1.969h13.969v1.969z"></path> </svg> </i> <i class="svg svg--add" data-icon="add"> <svg role="img" version="1.1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="24" height="24" viewBox="0 0 24 24"> <path fill="#444" d="M18.984 12.984h-6v6h-1.969v-6h-6v-1.969h6v-6h1.969v6h6v1.969z"></path> </svg> </i> Resource Center FAQs </a> </h3> <div class="accordion-panel-content"> <p><strong>How do I know which guidance pertains to my role?</strong></p> <p>Every role is different and can depend on the type of trials and indications you are working on. ACRP has created a list of the most common guidance referenced within our resources and utilized on our certification exams. This is not an exhaustive list but rather a list of some of the common guidance.</p> <p><strong>Do the links direct me to a particular guidance document?</strong></p> <p>There are a few links that direct you directly to the guidance (ISO and WMA), the rest will direct you to resource pages that may need to be searched for the guidance you are looking for.</p> <p><strong>Does ACRP have any additional resources to learn more about clinical research regulations and guidance?</strong></p> <p>At the bottom of the Guidance and Regulations Resource Center, you will find ACRP resources related to guidance within the industry. These resources may share best practices in implementing these guidelines as well as resources for learning and testing your know knowledge of the guidance.</p> <p><strong>When will the ACRP Certification Exams reflect the ICH Guideline changes?</strong></p> <p>ACRP Certification exams will align with the current ICH Guidelines as listed on the ICH website as of October 1, 2024. Any updates to the guidelines made after this date will be incorporated into the exams within one year.</p> </div> </div> <div class="accordion-panel"> <h3 class="accordion-panel-title"> <a href="#ich-e6r3-faqs"> <i class="svg svg--remove" data-icon="remove"> <svg role="img" version="1.1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="24" height="24" viewBox="0 0 24 24"> <path fill="#444" d="M18.984 12.984h-13.969v-1.969h13.969v1.969z"></path> </svg> </i> <i class="svg svg--add" data-icon="add"> <svg role="img" version="1.1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="24" height="24" viewBox="0 0 24 24"> <path fill="#444" d="M18.984 12.984h-6v6h-1.969v-6h-6v-1.969h6v-6h1.969v6h6v1.969z"></path> </svg> </i> ICH E6(R3) FAQs </a> </h3> <div class="accordion-panel-content"> <p><strong>What are the changes expected for ICH E6(R3)?</strong></p> <p>The International Council for Harmonisation (ICH) is expected to release its long-awaited and final guidance to update ICH E6(R2), following the first draft release which was disseminated in 2023. The new guidance is ICH E6(R3). This standard helps to assure that the rights, safety, and well-being of trial participants are protected, that the conduct is consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial results are reliable.</p> <p><strong>How will this pending change from the ICH E6 impact my role—or the roles of my team?</strong></p> <p>The changes in the ICH E6 guideline impact all those whose roles involve conducting and leading clinical research. It is critical to understand the specific guidance changes and their impact on the day-to-day implementation of clinical trials and studies—and how to incorporate the changes into trial implementation.</p> <p><strong>When should we be expected to put these changes into action?</strong></p> <p>Upon release of the new guidance, every organization—whether sponsor, CRO, or site—should immediately take action to review the new guidance and understand the changes. ACRP will release a series of resources that will help you understand and communicate the changes to your team and into your organization.</p> <p><strong>How do I train my teams on the new guidance?</strong></p> <p>ACRP is responding rapidly to adapt all its educational and training courseware to ensure the new guidance is incorporated. Our first priority will be to relaunch our Introduction to Good Clinical Practice course and adapt all ACRP Foundational Training. We will also ensure all ACRP Continuing Education is updated, an effort we expect to continue through the first half of 2025.</p> </div> </div> </div> <div class="column sidebar"> </div> </div></div> </section> </div> <footer class="footer"> <div class="wrap"> <div class="col-fullwidth"> <div class="footer-logo"> <img width="300" height="91" src="https://acrpnet.org/wp-content/uploads/2022/12/ACRP_Logo_White_CMYK_300px.png" class="attachment-full size-full" alt="" decoding="async" loading="lazy" /> </div> </div> <div class="col"> <div class="footer-copy"> <p>With more than 16,500 members, the Association of Clinical Research Professionals (ACRP) is the only non-profit solely dedicated to representing, supporting, and advocating for clinical research professionals. ACRP supports individuals and life science organizations globally by providing community, education, and credentialing programs. 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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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