{"id":614391,"date":"2024-06-14T12:06:31","date_gmt":"2024-06-14T16:06:31","guid":{"rendered":"https:\/\/platohealth.ai\/the-regulatory-binder-checklist-for-clinical-trial-sites\/"},"modified":"2024-06-14T13:34:26","modified_gmt":"2024-06-14T17:34:26","slug":"the-regulatory-binder-checklist-for-clinical-trial-sites","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/the-regulatory-binder-checklist-for-clinical-trial-sites\/","title":{"rendered":"The Regulatory Binder Checklist For Clinical Trial Sites","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"<header id=\"page-head\" class=\"pagetop-holder pagetop-gray\">\n<div class=\"pagetop container\">\n<div class=\"pagetop-title\">\n<div class=\"entry-title\"><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.advarra.com\/resource-library\/\">Resource Library<\/a><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/header>\n<div class=\"container container-width-sm\">\n<div class=\"ava-post-meta\">\n<p>\n      June 14, 2024    <\/p>\n<\/p><\/div>\n<div class=\"ava-blog-featured-image\">\n    <img fetchpriority=\"high\" decoding=\"async\" width=\"768\" height=\"349\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/06\/the-regulatory-binder-checklist-for-clinical-trial-sites.jpg\" class=\"attachment-medium_large size-medium_large wp-post-image lazyload\" alt data-sizes=\"auto\" data-eio-rwidth=\"1536\" data-eio-rheight=\"698\"><img decoding=\"async\" width=\"768\" height=\"349\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/06\/the-regulatory-binder-checklist-for-clinical-trial-sites.jpg\" class=\"attachment-medium_large size-medium_large wp-post-image\" alt data-eio=\"l\">    <\/div>\n<\/p><\/div>\n<div class=\"container container-width-sm\">\n<p>A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team. Though not legally binding, maintaining a regulatory binder is highly recommended for all intervention trials. This checklist offers a comprehensive framework for managing all necessary documents efficiently.<\/p>\n<p><a href=\"#download\">Download a Printable Version of this Checklist<\/a><\/p>\n<h2>Notes<\/h2>\n<h3>Terms Used Synonymously<\/h3>\n<ul>\n<li>Study binder<\/li>\n<li>Investigator binder<\/li>\n<li>Administrative binder<\/li>\n<li>Regulatory files<\/li>\n<li>Investigator\u2019s study files<\/li>\n<\/ul>\n<h3>Guidance Documents<\/h3>\n<ul>\n<li><strong>ICH GCP E6 Section 8<\/strong>: Specifies essential documents and their purposes<\/li>\n<li><strong>ICH GCP E6 4.9.4<\/strong>: Guidelines for maintaining trial documents to prevent accidental or premature destruction<\/li>\n<\/ul>\n<p>For more information, you can download our eBook detailing <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/info.advarra.com\/gcp-eb.html\">good clinical practice (GCP) and its role in the clinical research ecosystem<\/a>.<\/p>\n<h3>Centralization of Documents<\/h3>\n<p>When multiple studies share regulatory documents, it is most efficient to centralize them, often done electronically in an <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.advarra.com\/solutions-for\/clinical-trial-sites\/eregulatory-management-system\/\">eRegulatory management system<\/a> (eReg).<\/p>\n<ul>\n<li>Laboratory certifications and normal ranges<\/li>\n<li>Institutional review board (IRB) membership lists<\/li>\n<li>CVs<\/li>\n<li>CTEP 1572s<\/li>\n<\/ul>\n<p>These documents demonstrate the investigator\u2019s, sponsor\u2019s, and monitor\u2019s compliance with GCP and regulatory requirements.<\/p>\n<ul>\n<li><strong>Protocol and amendments<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document revisions of trial-related documents during the trial<\/li>\n<li><strong>Documents:<\/strong> Log of protocol changes, IRB-approved protocol with principal investigator (PI) signature page, IRB-approved case report forms, IRB-approved advertisements and participant information sheets, protocol amendments<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Informed consent documents<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document the informed consent<\/li>\n<li><strong>Documents:<\/strong> Log of informed consent versions, IRB-approved informed consents<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>IRB documentation<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document the trial has been subject to IRB review and approval<\/li>\n<li><strong>Documents:<\/strong> IRB federal assurance number, updated IRB roster, IRB approval letters, submissions, and correspondence including initial review, continuing review, advertisements, subject compensation, and other reporting requirements<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Investigator qualification documentation<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document qualifications and eligibility to conduct the trial<\/li>\n<li><strong>Documents:<\/strong> Updated investigator CVs (signed\/dated within two years), clinical licenses for PI and co-investigators, training certificates<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Clinical investigator\u2019s brochure<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document relevant and current scientific information for the investigational product has been provided<\/li>\n<li><strong>Documents:<\/strong> Investigator\u2019s brochure or package insert for approved medications<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>FDA documents (if applicable)<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document the investigator\u2019s agreement to conduct the study according to the protocol and GCP<\/li>\n<li><strong>Documents:<\/strong> FDA Forms 1571 and 1572, sample labels for investigational products, regulatory approval or authorization, FDA correspondence log<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Financial disclosure forms<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document compliance with FDA regulations regarding financial interests<\/li>\n<li><strong>Documents:<\/strong> Signed forms for PI and co-investigators<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Study communication<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document important decisions and agreements<\/li>\n<li><strong>Documents:<\/strong> Confidentiality agreement, data sharing agreement, material transfer agreement, signed agreements between sponsors and investigators, important decisions or notes to the study file<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Delegation of authority log<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document which study-related tasks the PI has delegated to others<\/li>\n<li><strong>Documents:<\/strong> Delegation of authority log, signature form<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Clinical research and study training<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document adequate training for all staff participating in the study<\/li>\n<li><strong>Documents:<\/strong> Documentation of training (e.g., human subject protection, GCP)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Screening\/Enrollment log<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document identification of subjects who entered pre-trial screening and those who were enrolled<\/li>\n<li><strong>Documents:<\/strong> Log of screened subjects without identifying information, subject identification code list (kept separately)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Signed consent documents<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document informed consent<\/li>\n<li><strong>Documents:<\/strong> Signed informed consent documents<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Study product records<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document the disposition and accountability of study products<\/li>\n<li><strong>Documents:<\/strong> Documentation of study product disposition and accountability<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Laboratory certification<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document the competence of the facility performing protocol-specific tests<\/li>\n<li><strong>Documents:<\/strong> CLIA, CAP, or other certifications, updated normal-range values for reference labs<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Specimen Tracking Log<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document the tracking and handling of specimens<\/li>\n<li><strong>Documents:<\/strong> Specimen tracking logs<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Serious adverse events (SAEs)\/Unanticipated problem documents<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document the sponsor was notified of all SAEs and related reports<\/li>\n<li><strong>Documents:<\/strong> SAE report forms, unanticipated problem forms, investigational new drug (IND) safety reports<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Protocol deviation form or memo<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document any deviations from the protocol<\/li>\n<li><strong>Documents:<\/strong> Protocol deviation forms or memos<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Clinical site monitoring visits<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document site visits and monitor findings<\/li>\n<li><strong>Documents:<\/strong> Site visit log, reports, and correspondence<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Sponsor correspondence<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document agreements or significant discussions regarding trial administration<\/li>\n<li><strong>Documents:<\/strong> Sponsor correspondence<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Data and safety monitoring documents<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document compliance and actions related to safety monitoring<\/li>\n<li><strong>Documents:<\/strong> Data and safety monitoring plan, reports generated for independent safety monitor(s), safety monitor meeting minutes<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><strong>Other documents<\/strong>\n<ul>\n<li><strong>Purpose:<\/strong> To document additional relevant information and procedures<\/li>\n<li><strong>Documents:<\/strong> Unmasking procedures for blinded trials, certificate(s) of confidentiality<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>Advarra eReg simplifies the management of essential documents, ensuring your clinical trials remain compliant and organized. This system provides key benefits to binder management such as:<\/p>\n<ul>\n<li><strong>21 CFR Part 11-compliant electronic signatures:<\/strong> Save time routing for signatures while ensuring compliance<\/li>\n<li><strong>Mobile signing:<\/strong> Staff can sign documents from their phones, no matter where they are<\/li>\n<li><strong>Electronic delegation of authority:<\/strong> Maintain a comprehensive and compliant delegation of authority log within eReg<\/li>\n<li><strong>Regulatory templates:<\/strong> Save time and eliminate redundant workflows with predefined templates for each new protocol<\/li>\n<li><strong>Standard operating procedure (SOP) management:<\/strong> Store and easily access SOPs in a central location<\/li>\n<li><strong>Email integration:<\/strong> Input documents easily and forward email correspondence directly into the system<\/li>\n<li><strong>IND storage:<\/strong> Manage IND documentation efficiently<\/li>\n<li><strong>Review sessions:<\/strong> Grant limited eReg access for internal and external monitors for easier document review<\/li>\n<\/ul>\n<h4 id=\"download\">Download a Printable Version of this Checklist<\/h4>\n<p class=\"back\"><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.advarra.com\/resource-library\/\" class=\"backlink\">Back to Resources<\/a><\/p>\n<\/div>\n<ul class=\"plato-post-bottom-links\">\n<li class=\"plato-post-bottom-link-amplifi\">SEO Powered Content &amp; PR Distribution. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.amplifipr.com\">Get Amplified Today.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platodata-network\">PlatoData.Network Vertical Generative Ai. 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Biotech and Clinical Trials Intelligence. <a href=\"https:\/\/platohealth.ai\" target=\"_blank\" rel=\"noopener\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-source\"><span>Source:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.advarra.com\/blog\/regulatory-binder-checklist\/\">https:\/\/www.advarra.com\/blog\/regulatory-binder-checklist\/<\/a><\/li>\n<\/ul>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"excerpt":{"rendered":"<p>Resource Library June 14, 2024 A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team. Though not legally binding, maintaining a regulatory binder is highly recommended [&hellip;]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":614403,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[49],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/614391"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=614391"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/614391\/revisions"}],"predecessor-version":[{"id":614402,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/614391\/revisions\/614402"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/614403"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=614391"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=614391"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=614391"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}