CINXE.COM

<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML+RDFa 1.0//EN" "http://www.w3.org/MarkUp/DTD/xhtml-rdfa-1.dtd"> <html xmlns="http://www.w3.org/1999/xhtml" lang="en" version="XHTML+RDFa 1.0" dir="ltr" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:dc="http://purl.org/dc/terms/" xmlns:foaf="http://xmlns.com/foaf/0.1/" xmlns:og="http://ogp.me/ns#" xmlns:rdfs="http://www.w3.org/2000/01/rdf-schema#" xmlns:sioc="http://rdfs.org/sioc/ns#" xmlns:sioct="http://rdfs.org/sioc/types#" xmlns:skos="http://www.w3.org/2004/02/skos/core#" xmlns:xsd="http://www.w3.org/2001/XMLSchema#"> <head profile="http://www.w3.org/1999/xhtml/vocab"> <meta http-equiv="Content-Type" content="text/html; charset=utf-8" /> <meta name="Generator" content="Drupal 7 (http://drupal.org)" /> <link rel="canonical" href="/quality-management-practices" /> <link rel="shortlink" href="/node/1416" /> <link rel="shortcut icon" href="https://hub.ucsf.edu/profiles/ucsf_b1gfoot/themes/ucsf_b1gfoot_theme/favicon.ico" type="image/vnd.microsoft.icon" /> <meta name="viewport" content="width=device-width, initial-scale=1, maximum-scale=1" /> <meta property="og:image" content="https://hub.ucsf.edu/profiles/ucsf_b1gfoot/themes/ucsf_b1gfoot_theme/img/img-metatag.jpg" /> <meta property="og:image:width" content="940" /> <meta property="twitter:image" content="https://hub.ucsf.edu/profiles/ucsf_b1gfoot/themes/ucsf_b1gfoot_theme/img/img-metatag.jpg" /> <meta property="twitter:card" content="summary" /> <meta property="og:site_name" content="Clinical Research Resource HUB" /> <meta property="twitter:url" content="https://hub.ucsf.edu/quality-management-practices" /> <meta property="og:url" content="https://hub.ucsf.edu/quality-management-practices" /> <meta property="twitter:title" content="Quality Management Practices | Clinical Research Resource HUB" /> <meta property="og:title" content="Quality Management Practices" /> <title>Quality Management Practices | Clinical Research Resource HUB</title> <link type="text/css" rel="stylesheet" href="https://hub.ucsf.edu/sites/g/files/tkssra261/f/css/css_kShW4RPmRstZ3SpIC-ZvVGNFVAi0WEMuCnI0ZkYIaFw.css" media="all" /> <link type="text/css" rel="stylesheet" href="https://hub.ucsf.edu/sites/g/files/tkssra261/f/css/css_EJL_7lrjsH8BZ6q38g9TN9dgvY5IouUd4PiJZQyBEFI.css" media="all" /> <link type="text/css" rel="stylesheet" href="https://hub.ucsf.edu/sites/g/files/tkssra261/f/css/css_rV3Wod_e6ST6El0CA65NgFrvcFHnCpm1z0SGwM9reQg.css" media="all" /> <style type="text/css" media="all"> <![CDATA[/*> </style> <link type="text/css" rel="stylesheet" href="https://cdnjs.cloudflare.com/ajax/libs/hopscotch/0.2.5/css/hopscotch.min.css" media="all" /> <link type="text/css" rel="stylesheet" href="https://hub.ucsf.edu/sites/g/files/tkssra261/f/css/css_E4VlyxyL3JMcT6dslWLGb0uQdoI2bh_Xj0N65V-bcWo.css" media="all" /> <link type="text/css" rel="stylesheet" href="https://maxcdn.bootstrapcdn.com/font-awesome/4.4.0/css/font-awesome.min.css" media="all" /> <link type="text/css" rel="stylesheet" href="https://hub.ucsf.edu/sites/g/files/tkssra261/f/css/css_-5KGL3kpG9BJtjhjan_sSs2LNKUh8DXr0FbFKbHMQxM.css" media="all" /> <link type="text/css" rel="stylesheet" href="https://hub.ucsf.edu/sites/g/files/tkssra261/f/css/css_47DEQpj8HBSa-_TImW-5JCeuQeRkm5NMpJWZG3hSuFU.css" media="print" /> <style type="text/css" media="all"> <![CDATA[/*> </style> <link type="text/css" rel="stylesheet" href="https://hub.ucsf.edu/sites/g/files/tkssra261/f/css/css_zf20glj0zlt-i5VyoLzB0ei0GolLQsGYQTTXFJ83i0o.css" media="all" /> <script type="text/javascript" src="https://hub.ucsf.edu/sites/g/files/tkssra261/f/js/js_Pt6OpwTd6jcHLRIjrE-eSPLWMxWDkcyYrPTIrXDSON0.js"></script> <script type="text/javascript" src="https://hub.ucsf.edu/sites/g/files/tkssra261/f/js/js_onbE0n0cQY6KTDQtHO_E27UBymFC-RuqypZZ6Zxez-o.js"></script> <script type="text/javascript" src="https://hub.ucsf.edu/sites/g/files/tkssra261/f/js/js_MItSgdSkwVZBTl5MsdgLy94Mp-HJ6pvBHirm2wMSuzA.js"></script> <script type="text/javascript" src="https://cdnjs.cloudflare.com/ajax/libs/hopscotch/0.2.5/js/hopscotch.min.js"></script> <script type="text/javascript" src="https://hub.ucsf.edu/sites/g/files/tkssra261/f/js/js_Md_O18EkEkENyifmdSaTOM057n9-b6JB039etuiVtGE.js"></script> <script type="text/javascript" src="https://www.googletagmanager.com/gtag/js?id=UA-1142388-14"></script> <script type="text/javascript"> <![CDATA[//><!]]> </script> <script type="text/javascript"> <![CDATA[//><!]]> </script> <script type="text/javascript" src="https://hub.ucsf.edu/sites/g/files/tkssra261/f/js/js_3KU2G0XuUwThidq7lpTBQghUO1g1ty4dEdv-co66Xqw.js"></script> <script type="text/javascript" src="https://hub.ucsf.edu/sites/g/files/tkssra261/f/js/js__pev76oqunwyHrozBOUwthVLhzUZgLLfKlmOonOmdkg.js"></script> <script type="text/javascript"> <![CDATA[//><!]]> </script> </head> <body class="html not-front not-logged-in page-node page-node- page-node-1416 node-type-page slider-secondary ucsf-b1gfoot font--header--helveticaneue slider-secondary-no-image profile--grid sidebar sidebar--left sidebar-color--white" > <div id="skip-link"> <a href="#main-content" class="element-invisible element-focusable">Skip to main content</a> </div> <div id="page-wrapper"> <div id="page"> <div class="ucsf-top-header row-full-width no-logo"> <div class="inside"> <ul class="menu"> <li class="first"><a href="https://www.ucsf.edu">University of California San Francisco</a></li> <li><a href="https://www.ucsfhealth.org/">UCSF Health</a></li> <li><a href="https://www.ucsf.edu/search" title="">Search UCSF</a></li> <li><a href="https://www.ucsf.edu/about">About UCSF</a></li> </ul> </div> </div> <div id="header" class="row-full-width"> <div class="inside clearfix"> <h1 id="site-name"> <a href="/" title="Home" rel="home"> Clinical Research Resource HUB </a> </h1> <div class="region region-header"> <div id="block-search-form" class="block block-search"> <div class="content"> <form onsubmit="if(this.search_block_form.value=='Search'){ alert('Please enter a search'); return false; }" action="/quality-management-practices" method="post" id="search-block-form" accept-charset="UTF-8"><div><div class="container-inline"> <h2 class="element-invisible">Search form</h2> <div class="form-item form-type-textfield form-item-search-block-form"> <label class="element-invisible" for="edit-search-block-form--2">Search... </label> <input title="Enter the terms you wish to search for." placeholder="Search..." class="text-input fa fa-search form-text" aria-hidden="" type="text" id="edit-search-block-form--2" name="search_block_form" value="" size="40" maxlength="128" /> </div> <div class="form-actions form-wrapper" id="edit-actions"><input type="submit" id="edit-submit" name="op" value="" class="form-submit" /></div><input type="hidden" name="form_build_id" value="form-0KVKqCl1KteU0xA0Gz86vgWKJKBBqhdn-pUFmxTT8Nc" /> <input type="hidden" name="form_id" value="search_block_form" /> </div> </div></form> </div> </div> <div id="block-ucsf-b1gfoot-tweaks-header-socialmedia" class="block block-ucsf-b1gfoot-tweaks"> <div class="content"> <div class="nav-social"></div> </div> </div> <div id="block-menu-block-1" class="block block-menu-block"> <div class="content"> <div class="menu-block-wrapper menu-block-1 menu-name-main-menu parent-mlid-0 menu-level-1"> <ul class="menu"><li class="first expanded menu-mlid-1381"><a href="/" title="">Resources for...</a><ul class="menu"><li class="first leaf has-children menu-mlid-1901"><a href="/who-you-are/investigators">Investigators</a></li> <li class="leaf menu-mlid-2011"><a href="/who-you-are/study-staff">Study Staff</a></li> <li class="leaf has-children menu-mlid-2016"><a href="/who-you-are/participants">Participants</a></li> <li class="leaf menu-mlid-2021"><a href="/who-you-are/partners">Partners / Affiliates</a></li> <li class="leaf menu-mlid-2041"><a href="/clinical-research/design-study">Study Design</a></li> <li class="leaf menu-mlid-2046"><a href="/clinical-research/setup-study">Study Set-Up</a></li> <li class="leaf menu-mlid-2051"><a href="/clinical-research/conduct-study">Study Conduct</a></li> <li class="last leaf menu-mlid-2056"><a href="/clinical-research/close-out-study">Study Close-Out</a></li> </ul></li> <li class="expanded active-trail menu-mlid-1906"><a href="/trial-management" class="active-trail">Trial Management</a><ul class="menu"><li class="first leaf has-children menu-mlid-2071"><a href="/clinical-trial-consent-development">Consent Development</a></li> <li class="leaf menu-mlid-2126"><a href="/coverage-analysis">Coverage Analysis</a></li> <li class="leaf has-children menu-mlid-2076"><a href="/data-safety-monitoring">Data Safety Monitoring</a></li> <li class="leaf menu-mlid-2161"><a href="/data-management">Data Management</a></li> <li class="leaf has-children menu-mlid-2236"><a href="/feasibility-analysis-scientific-review">Feasibility Guidance</a></li> <li class="leaf menu-mlid-2411"><a href="/protocol-development">Protocol Development</a></li> <li class="leaf menu-mlid-2111"><a href="/recruitment-strategy">Recruitment Resources</a></li> <li class="leaf has-children menu-mlid-2081"><a href="/virtual-regulatory-binder" title="removed whom to contact as the QIU no longer provides consultations on the virtual binder.">Regulatory Binder</a></li> <li class="leaf has-children menu-mlid-2146"><a href="/safety-reporting">Safety Reporting</a></li> <li class="last leaf has-children active-trail menu-mlid-2086"><a href="/clinical-study-management" class="active-trail">Study Management</a></li> </ul></li> <li class="expanded menu-mlid-1911"><a href="/regulatory">Regulatory</a><ul class="menu"><li class="first leaf has-children menu-mlid-2091"><a href="/21-cfr-part-11-compliance">21 CFR Part 11 Compliance</a></li> <li class="leaf has-children menu-mlid-2096"><a href="https://compliance.ucsf.edu/clinicaltrialsgov-regulatory-support-0" title="">ClinicalTrials.gov</a></li> <li class="leaf has-children menu-mlid-2101"><a href="/fda-and-ohrp-inspections">FDA & OHRP Inspections</a></li> <li class="leaf menu-mlid-2061"><a href="/fda-alerts">FDA Alerts</a></li> <li class="leaf has-children menu-mlid-2106"><a href="/ide-development-process">IDE Development Process</a></li> <li class="leaf has-children menu-mlid-2066"><a href="/ind-development-process">IND Development Process</a></li> <li class="leaf has-children menu-mlid-2326"><a href="/sops">SOPs</a></li> <li class="last leaf menu-mlid-4296"><a href="/clinical-laboratory-testing">Clinical Laboratory Testing</a></li> </ul></li> <li class="last expanded menu-mlid-1996"><a href="/training">Training</a><ul class="menu"><li class="first leaf menu-mlid-2156"><a href="/apex-stor-ucare">APeX / STOR & other</a></li> <li class="leaf has-children menu-mlid-2211"><a href="/research-coordinator">Clinical Research Coordinators</a></li> <li class="leaf menu-mlid-2431"><a href="/human-subjects">Human Subjects</a></li> <li class="leaf menu-mlid-2376"><a href="/imedris-training">iRIS / IRB Submissions</a></li> <li class="leaf menu-mlid-2476"><a href="/investigator-education">Investigator Education</a></li> <li class="leaf menu-mlid-22256"><a href="/oncore">OnCore</a></li> <li class="leaf menu-mlid-2466"><a href="/safety">Safety Courses</a></li> <li class="last leaf menu-mlid-2596"><a href="/glossaries">Glossaries</a></li> </ul></li> </ul></div> </div> </div> </div> </div> </div> <div id="breadcrumb" class="row-full-width"><div class="inside"><h2 class="element-invisible">You are here</h2><div class="breadcrumb"><a href="/">Home</a> > <a href="/trial-management">Trial Management</a> > <a href="/clinical-study-management">Study Management</a> > <span class="breadcrumb-page-title">Quality Management Practices</span></div></div></div> <h1 class="title" id="page-title">Quality Management Practices</h1> <div class="content-top"> </div> <div id="main-wrapper"> <div id="main" class="clearfix"> <div id="content" class="column"> <div class="inside"> <a id="main-content"></a> <div class="tabs"></div> <div class="region region-content"> <div id="block-system-main" class="block block-system"> <div class="content"> <div id="node-1416" class="node node-page slider-secondary clearfix" about="/quality-management-practices" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="Quality Management Practices" class="rdf-meta element-hidden"></span><span property="sioc:num_replies" content="0" datatype="xsd:integer" class="rdf-meta element-hidden"></span> <div class="content"> <div class="field field-name-field-last-revised field-type-datetime field-label-inline inline"><div class="field-label">Last revised<span class="colon">:</span> </div><div class="field-items"><div class="field-item even"><span property="dc:date" datatype="xsd:dateTime" content="2015-09-24T15:43:43-07:00" class="date-display-single">09/24/2015</span></div></div></div><div class="field field-name-field-body field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even"><p>Ideally, every clinical trial should have a Clinical Trial <strong>Quality Management Plan (QMP)</strong> describing the tools that will be used to ensure study quality. The extent and nature of monitoring may be determined based on various considerations such as trial design, complexity, size, risks to subjects, and endpoints of the trial.</p> <p>One of the benefits of developing and implementing a QMP includes developing proactive communication among clinical trial team members. This benefits clinical trial teams by encouraging early identification and resolution of clinical trial problems and concerns. Implementing a Clinical Trial QMP can also encourage conformity with Standard Operating Procedure, Good Clinical Practice (GCP), Good Laboratory Practice, and UCSF policies and procedures. This leads to an overall reduction in external (Sponsor, FDA) and internal (UCSF) data queries, and helps reduce clinical trial closeout time.</p> <p><strong>Quality Management Plans </strong>include all the activities undertaken to verify that the requirements for quality of the trial related activities have been fulfilled. Listed below are several logs and checklists that might help with quality management plan development:</p> <ul> <li><a href="/sites/g/files/tkssra261/f/Chart_Audit_Tool.doc">Chart Audit Tool</a></li> <li><a href="/sites/g/files/tkssra261/f/RegulatoryReviewTool.doc">Regulatory File Review Tool</a></li> <li><a href="/sites/g/files/tkssra261/f/Monitoring_Log.doc">Monitoring Log</a></li> <li><a href="/quick-reference">Quick Reference Page</a></li> </ul> <p>Industry sponsored clinical trials usually have a comprehensive monitoring plan. Regular monitoring of a trial is very helpful to verify compliance of the trial with currently approved protocol, Good Clinical Practice and applicable regulatory requirements.</p> <p><strong>Source Data</strong> is defined as all information in original records or certified copies of clinical findings, observations, or other activities that are necessary for reconstruction and evaluation of the trial. The records that contain source data are called Source Documents. Source Document Verification is an important part of monitoring. Source data is verified by reviewing all the data variables in the case report form accurately reflect information in the source documents.</p> <p>Researchers may choose any option that is appropriate for the trial, some of the options include; a review of all data variables in the case report form for all enrolled subjects, a review of all CRF data for a percentage (e.g. 5%) of patients enrolled or even a review of only certain specified variables on all or some CRFs (for example, only the eligibility criteria).</p> <p><a href="/regulatory-binder"><span></span>Essential Documents</a> permit evaluation of the conduct of a trial and the quality of data produced. These documents serve to demonstrate compliance with standards of Good Clinical Practice and with all applicable regulatory requirements. Filing these documents in a timely manner can greatly assist in the successful CTQMP and management of a trial. </p> <ul> <li><a href="/sites/g/files/tkssra261/f/Quality_Management_NIAID.pdf">Sample Quality Management Plan</a></li> <li><a href="/sites/g/files/tkssra261/f/RegulatoryReviewTool.doc">Sample Clinical Quality Management Regulatory File Review Tool</a></li> <li><a href="http://www.fda.gov/oc/gcp/regulations.html">Food and Drug Administration (FDA) Regulations</a></li> <li><span><a href="/qm-definitions">Commonly Used QM Definitions</a></span></li> </ul> <h4> </h4> </div></div></div> </div> </div> </div> </div> </div> </div> </div> <div id="sidebar" class="column"> <div class="sidebar"> <div class="section"> <div class="region region-sidebar"> <div id="block-menu-block-3" class="block block-menu-block"> <h3><a href="/clinical-study-management" class="active-trail">Study Management</a></h3> <div class="content"> <div class="menu-block-wrapper menu-block-3 menu-name-main-menu parent-mlid-0 menu-level-3"> <ul class="menu"><li class="first leaf menu-mlid-2316"><a href="/study-initiation">Study Initiation</a></li> <li class="leaf menu-mlid-2266"><a href="/subject-management">Subject Management</a></li> <li class="expanded menu-mlid-2306"><a href="/specimen-management">Specimen Management</a><ul class="menu"><li class="first last leaf menu-mlid-2601"><a href="/specimen-transport">Specimen Transport</a></li> </ul></li> <li class="leaf menu-mlid-2321"><a href="/study-tracking-reporting">Tracking & Reporting</a></li> <li class="leaf menu-mlid-2141"><a href="/accountability-logs">Accountability Logs</a></li> <li class="expanded active-trail active menu-mlid-2201"><a href="/quality-management-practices" class="active-trail active">Quality Management Practices</a><ul class="menu"><li class="first last leaf menu-mlid-2226"><a href="/qm-definitions">Commonly used QM Definitions</a></li> </ul></li> <li class="last leaf menu-mlid-18071"><a href="http://cancer.ucsf.edu/clinical-research/conducting-cancer-research" title="Cancer Research Activation Workflow">Cancer Research Activation Workflow</a></li> </ul></div> </div> </div> </div> </div> </div> </div> </div></div> <div id="footer"> <div class="section"> <div class="region region-footer"> <div id="block-block-6" class="block block-block"> <div class="content"> <style type="text/css"> <![CDATA[/* ><!]]>*/ </style> <div class="quickref"> <h2 style="color:#000;font-size:22px;margin:0;padding: 0 0 6px;">Quick Reference</h2> <div class="wysiwyg_threecols layout--33-33-33"> <div class="wysiwyg_threecols--first"> <ul> <li><a href="http://policies.ucsf.edu/" target="_blank">Campus Policies</a></li> <li><a href="http://cancer.ucsf.edu/" target="_blank">Cancer Center (HDFCCC)</a></li> <li><a href="http://accelerate.ucsf.edu/research/crs" target="_blank">Clinical Research Services</a></li> <li><a href="http://ctsi.ucsf.edu" target="_blank">Clinical & Translational Science Institute (CTSI)</a></li> </ul> </div> <div class="wysiwyg_threecols--second"> <ul> <li><a href="http://coi.ucsf.edu/" target="_blank">Conflicts of Interest (COI)</a></li> <li><a href="http://accelerate.ucsf.edu/consult" target="_blank">Consultation Services</a></li> <li><a href="http://accelerate.ucsf.edu/cores/" target="_blank">Cores Search</a></li> <li><a href="https://ehs.ucsf.edu/" target="_blank">Environment, Health and Safety</a></li> <li><a href="http://compliance.ucsf.edu/" target="_blank">Ethics & Compliance</a></li> </ul> </div> <div class="wysiwyg_threecols--third"> <ul> <li><a href="http://globalhealthsciences.ucsf.edu/" target="_blank">Global Health Sciences</a></li> <li><a href="http://ita.ucsf.edu/" target="_blank">Innovation, Technology & Alliances</a></li> <li><a href="http://irb.ucsf.edu" target="_blank">IRB / Human Research Protection Program</a></li> <li><a href="https://osr.ucsf.edu/" target="_blank">Office of Sponsored Research</a></li> <li><a href="http://profiles.ucsf.edu" target="_blank">UCSF Profiles</a></li> </ul> </div> </div> </div> <p style="float: right; margin: 1.2em 30px -1.5em; text-align: right; width: 6em;"><a href="/cdn-cgi/l/email-protection#5119041311243222377f343524" style="color:#FFF"><span class="__cf_email__" data-cfemail="ce869b8c8ebbadbda8e0abaabb">[email protected]</span></a></p> </div> </div> </div> <div class="footer-bottom"> <nav aria-label="Footer Navigation" class="footer--navigation"> <ul> <li><a href="/cdn-cgi/l/email-protection#a9e1fcebe9dccadacf87cccddc">Contact Us</a></li> <li><a href="https://www.ucsf.edu/accessibility-resources">Accessibility</a></li> <li><a href="https://www.ucsf.edu/website-privacy-policy">Privacy Policy</a></li> <li><a href="https://websites.ucsf.edu/website-terms-use">Terms of Use </a></li> <li><a href="https://websites.ucsf.edu/azlist">A-Z Website List</a></li> </ul> </nav> <div class="footer--copyright"> <p>© 2024 The Regents of the University of California</p> </div> </div> </div> </div> </div> </div> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script><script type="text/javascript"> /*<![CDATA[*/ (function() { var sz = document.createElement('script'); sz.type = 'text/javascript'; sz.async = true; sz.src = '//siteimproveanalytics.com/js/siteanalyze_8343.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(sz, s); })(); /*]]>*/ </script> </body> </html>