{"id":226,"date":"2019-11-19T21:28:04","date_gmt":"2019-11-19T21:28:04","guid":{"rendered":"https:\/\/www.socra.org\/blog\/?p=226"},"modified":"2019-11-19T21:28:05","modified_gmt":"2019-11-19T21:28:05","slug":"the-value-of-centralized-monitoring","status":"publish","type":"post","link":"https:\/\/www.socra.org\/blog\/the-value-of-centralized-monitoring\/","title":{"rendered":"The Value of Centralized Monitoring"},"content":{"rendered":"\n<figure class=\"wp-block-image\"><img decoding=\"async\" loading=\"lazy\" width=\"1024\" height=\"714\" src=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/11\/iStock-991799170-1024x714.jpg\" alt=\"group of clinical researchers\" class=\"wp-image-227\" srcset=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/11\/iStock-991799170-1024x714.jpg 1024w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/11\/iStock-991799170-300x209.jpg 300w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/11\/iStock-991799170-768x535.jpg 768w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/11\/iStock-991799170.jpg 1227w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h4 style=\"text-align:center\">Joanne Malia<br> Associate Director, Clinical Documentation Management<br>&nbsp;Regeneron Pharmaceuticals   <\/h4>\n\n\n\n<p><strong><em>Abstract<\/em><\/strong><em>:<\/em><em> <\/em><em>Regulatory agencies are advocating for sponsors to\ntake risk-based approaches in various clinical trial-related activities,\nespecially in the area of monitoring. Sponsors are looking at and beginning to\nuse centralized monitoring.<\/em><em> This article describes\ncentralized monitoring, r<\/em><em>egulatory and industry expectations and initiatives\nrelated to centralized monitoring, the value of centralized monitoring in <\/em><em>enhancing data quality in clinical trials, and<\/em><em> use and\ndocumentation of centralized monitoring, <\/em><\/p>\n\n\n\n<p><em>Disclaimer: The views and\nopinions expressed in this article are those of the author and should not be\nattributed to the Society of Clinical Research Associates or Regeneron\nPharmaceuticals.<\/em><\/p>\n\n\n\n<!--more-->\n\n\n\n<h2><strong>Regulatory Expectations <\/strong><\/h2>\n\n\n\n<p>In 2012, the U.S. Food and\nDrug Administration (FDA) released an excellent guidance document entitled <em>Guidance for Industry: Oversight of Clinical\nInvestigations \u2013 A Risk-based Approach to Monitoring. <\/em>This is a clear\nguidance document that lays out the FDA\u2019s thoughts behind the risk-based\napproach and the agency\u2019s expectations for monitoring plans. The guidance\ndocument defines risk-based monitoring and encourages sponsors to prioritize\nand focus monitoring on the critical data and processes.<\/p>\n\n\n\n<p>Around the same time, the European\nMedicines Agency (EMA) released <em>Reflection\nPaper on Risk Based Quality Management in Clinical Trials. <\/em>The reflection paper\nlays out methodology for risk assessment, control, review, management, and communication\nthroughout the course of the study. Along with identification of risks, the\nreflection paper covers mitigating, or if possible, eliminating risks, and evaluating\nrisks throughout the study to ensure that the risks have not changed\ndrastically or that new risks have not arisen, and communicating risks to\nappropriate stakeholders. Appropriate stakeholders can be upper management, other\nteam members, or even clinical research sites and contract research\norganizations (CROs).<\/p>\n\n\n\n<h2><strong>Clinical Trials Transformation Initiative and\nTranscelerate<\/strong><\/h2>\n\n\n\n<p>The Clinical Trials\nTransformation Initiative (CTTI) is a public-private partnership to develop and\ndrive adoption of practices that will increase the quality and efficiency of\nclinical trials. CTTI encouraged \u201cquality by design\u201d in the development of protocols.\nThis includes quality control steps in the protocol, and ensuring that staff\nmembers are trained and understand what they need to do. CTTI advocated for\nquality data and adherence to the protocol. A number of regulators participated\nin the CTTI initiative. <\/p>\n\n\n\n<p>TransCelerate is an industry\ninitiative. This non-profit organization works across the biopharmaceutical\nresearch and development community to improve the health of people around the\nworld. The large pharmaceutical and biotechnology companies that formed TransCelerate\nrealized that the current monitoring process did not work well. Monitoring involved\nmany resources, and evidence showed that it was not effective. TransCelerate made\nimproving monitoring one of its initial initiatives and developed a framework\nfor risk-based monitoring. Much of TransCelerate\u2019s information, including\ntraining documentation and white papers, is publicly available on its website. <\/p>\n\n\n\n<h2><strong>Integrated Quality and Risk Management Plan <\/strong><\/h2>\n\n\n\n<p>TransCelerate\u2019s framework for\nrisk-based monitoring includes the integrated quality and risk management plan,\nwhich defines the critical data and processes for a study and recommends that\nteams focus on what matters most to the specific study (Table 1). The framework\nencourages that \u201cquality by design\u201d be implemented in these areas. The integrated\nquality and risk management plan would be the key plan to which all other plans\nwould adhere and align.&nbsp; &nbsp;<\/p>\n\n\n\n<p>The integrated quality and\nrisk management plan is the first document generated after the protocol. It\ndefines the critical data and processes for the study. The monitoring plan,\ndata management plan, statistical plan, and other plans would be in alignment\nwith the integrated quality and risk management plan.<\/p>\n\n\n\n<p>Critical data and critical\nprocesses are defined in the integrated quality and risk management plan. The\ncritical data include important safety and efficacy data. The critical processes\nare the standard operating procedures or processes that support quality data.\nThis includes the informed consent process, ensuring that monitoring is done\nappropriately, as well as safety reporting.<\/p>\n\n\n\n<p>The integrated quality and\nrisk management plan can also be developed at the program level for all of the\nstudies for a particular therapeutic. The plan identifies clinical research\nrisks and includes actions to proactively identify, assess, and manage risk.\nSince the plan also defines the critical data and processes, it should focus on\nsupporting the primary efficacy endpoints and critical safety parameters.\nInstead of, for example, dealing with the twenty questionnaires that subjects\ncomplete, the plan focuses on the questionnaires that support the primary\nefficacy objectives or a safety evaluation. Less monitoring may be done on the\nmore experimental endpoints and parameters.<\/p>\n\n\n\n<h2><strong>From Integrated Quality and Risk Management Plan to\nMonitoring Plan<\/strong><\/h2>\n\n\n\n<p>The monitoring plan defines\nall of the monitoring activities that might be included in the study to ensure\nthat the study provides quality data and that the subjects are safe (Table 2).\nUsing the framework of theintegrated\nquality and risk management plan, the monitoring plan expands the \u201ctraditional\u201d\nmonitoring plan to include on-site, off-site, and central monitoring. All\nmonitoring, including pharmacy monitoring and medical monitoring, should be\ndefined in the plan.<\/p>\n\n\n\n<p>Risk indicators should be\nidentified in the monitoring plan. If, for example, the threshold for serious\nadverse events in the study is two per subject and one clinical research site suddenly\nstarted having five serious adverse events per subject, this would require\naction to determine what is happening and what might be causing the difference\nat this site. The monitoring plan must include actions, and as necessary, an escalation\npath that includes the investigator.<\/p>\n\n\n\n<p>It is also necessary to\nconsider the difference between source data verification and source data review.\nTransCelerate advocates a source data review process, which is more holistic\nthan source data verification. According to TransCelerate:<\/p>\n\n\n\n<ul><li>\u201cSource data verification is the process by which data within the case report form or other data collection systems are compared to the original source or information (and vice versa) to confirm that data were transcribed accurately.\u201d<\/li><li>\u201cSource data review involves review of source documentation to      check the quality of the source, review protocol compliance, ensure that the critical processes and source documentation are adequate to ascertain investigator involvement and appropriate delegation, and to assess compliance to other areas.\u201d&nbsp; <\/li><\/ul>\n\n\n\n<p>TransCelerate advocates\nincluding all of this information into the evaluation of what is happening\nacross the study and using risk-based monitoring metrics. Metrics include\ndeveloping threshold values for activities so that metrics or reports that\nindicate critical levels will prompt the necessary actions.<\/p>\n\n\n\n<p>TransCelerate has proposed\nmany metrics for risk-based monitoring. Typically, metrics focus on quality,\ntimeliness (visits, entering information in the case report form, etc.), and\nefficiency of activities. Using those pre-defined thresholds can help sponsors\ndetermine whether action is necessary. <\/p>\n\n\n\n<h2><strong>Centralized Monitoring<\/strong><\/h2>\n\n\n\n<p>Centralized monitoring is a\nmore statistical approach to handling this information and looking across sites\nor across patients within a clinical research site (Table 3). The FDA definition\nof centralized monitoring states that it:<\/p>\n\n\n\n<p>\u201cConsists\nof a remote evaluation carried out by sponsor personnel or representatives\n(e.g., clinical monitors, data management personnel, or statisticians) at a\nlocation other than the sites at which the clinical investigation is being\nconducted.\u201d <\/p>\n\n\n\n<p>Review of the submitted data for\nquality is part of centralized monitoring, which is performed in order to\nidentify and address missing and inconsistent data, data outliers, and\npotential protocol deviations that might not be identified without this\napproach. Centralized monitoring also enables sponsors to conduct statistical\nanalyses to uncover data trends such as range, consistency, completeness of\ndata, or unusual distribution of data within and between clinical research\nsites. <\/p>\n\n\n\n<p>For example, one clinical\nresearch site may be having difficulty because staff members are interpreting\nthe protocol differently than the other sites. Sometimes these trends indicate\nthat something is happening that requires additional monitoring at a clinical\nresearch site or requires a conversation with the site or the monitor (CRA).<\/p>\n\n\n\n<p>Centralized monitoring can be\nused to analyze performance metrics, verify certain critical source data\nremotely, and complete some administrative and regulatory tasks. Clinical\nresearch site performance metrics such as high screen failures or withdrawals, a\nhigh number of subject eligibility violations, or study delays can be analyzed to\nuncover poor performance or noncompliance. &nbsp;<\/p>\n\n\n\n<h2><strong>Benefits of Centralized Monitoring<\/strong><\/h2>\n\n\n\n<p>Before the term \u201ccentralized\nmonitoring\u201d was being used, one of the statisticians with whom the author worked\nwanted to analyze data between various clinical research sites. He looked at data\non temperature and identified a site that had an unqualified and uncalibrated\nthermometer. He worked with the study team to have the site fix this problem. The\nstatistician showed that centralized monitoring could be used to identify\ninformation that could potentially affect study results.<\/p>\n\n\n\n<p>Centralized monitoring has\nmany benefits (Table 4). It enables sponsors to look at the protocol and look\nat critical data to see what might affect efficacy or safety variables. This\ninformation can then be used to fix issues or lessen their affect. This\nmethodology has been used in the past to identify data fabrication. Often,\npeople who fabricate data are not creative, and the data similarities are\nfairly large and obvious.<\/p>\n\n\n\n<p>On-site monitoring can be targeted\nto higher-risk clinical research sites. Centralized monitoring enables the\nsponsor to identify sites that are having more difficulty than other sites.\nPerhaps one site does not understand the protocol or has new staff members who\nrequire training. <\/p>\n\n\n\n<p>Many regulators hope that\ncentralized monitoring will increase communication with clinical research site\nstaff. With the sponsor, CRO, and site staff looking at the data, issues can be\naddressed before they become large problems. Centralized monitoring will also help\nmonitors prioritize on-site monitoring to the processes that are critical to\nthe success of the study. &nbsp;<\/p>\n\n\n\n<p>Focusing on what matters is a\nkey benefit of centralized monitoring. Monitoring should focus on the primary\nefficacy and safety variables, not on spending limited resources dealing with\ndata that will not impact the study results.<\/p>\n\n\n\n<p>When implementing centralized\nmonitoring, sponsors often expect to save money because monitors are not\ntraveling to the clinical research sites as many times. Centralized monitoring\ndoes not necessarily save money. This methodology requires software and, if\ncentralized monitoring is done internally, programmers are required to program and\nanalyze much of this information. It may be a trade-off, with less money spent\non visiting sites and more money spent on programming and analysis. Some CROs\nalready have centralized monitoring capability.<\/p>\n\n\n\n<p>The FDA\u2019s <em>Guidance for Industry: Oversight of Clinical\nInvestigations \u2013 A Risk-based Approach to Monitoring<\/em> defines what really\nmatters in monitoring, including verifying that informed consent has been properly\nobtained and that the right patients are enrolled in the study (adherence to\nprotocol eligibility criteria). Risk-based monitoring should also focus on appropriate\naccountability, administration of the investigational product, and verification\nof procedures and assessments involving study endpoints, protocol-required\nsafety assessments, reporting of serious adverse events, subject deaths, and\nwithdrawals, on time and to the proper authorities. Any procedures that are essential\nto the integrity of the clinical trial, such as maintaining the blind specified\nevents that must be adjudicated and allocation concealment, must be verified. Study-specific\nissues related to the type of study, therapeutic area, and type of medication\nor device under study must also be verified.<\/p>\n\n\n\n<p>TransCelerate has a list of\nsuggested metrics for risk-based monitoring. Metrics can also be modified for\nuse on specific studies or by specific sponsors. Under protocol compliance, for\nexample, metrics include:<\/p>\n\n\n\n<ul><li>Number of important protocol violations<\/li><li>Major protocol deviation rate<\/li><li>Minor protocol deviation rate.<\/li><\/ul>\n\n\n\n<h2><strong>Statistical Analyses<\/strong><\/h2>\n\n\n\n<p>Statistical analyses are a\nmajor component of centralized monitoring (Table 5). It is not necessary to\nhave a statistical background to understand the statistical analyses in\ncentralized monitoring; however, it is helpful to have a statistician assist\nwith the programming of the analyses. <\/p>\n\n\n\n<p>One type of statistical\nanalysis based on centralized monitoring is a comparison of data within and\nbetween patients and between sites. Since these tools often look at the\nsimilarity of data, it is important to be careful about which data are being\ncompared. In the author\u2019s past, she&nbsp; compared\nall of the case report form data (CFR) including patient diaries across\npatients and sites. Since much of the information on the patient diary was\nexpected to be similar, this comparison resulted in a great deal of false\npositive issues that all needed investigation and resolution. It would have\nbeen better to have only analyzed the CRF data and not the diary data. <\/p>\n\n\n\n<p>Software packages often identify\ntrends, outliers, and missing data. At times, it is easy to determine whether\nthe outlier requires investigation. The software is very helpful in detecting\nfraudulent behavior and data. Sponsors must have a process in place to deal\nwith signals of problems identified through the statistical analyses, such as\ninvestigating the problem first, then bringing in quality assurance to discuss\nthe problem. It is also helpful to document the issues and their resolution to\nprevent reworking the same issues throughout the study.&nbsp; <\/p>\n\n\n\n<p>The statistical analyses in\ncentralized monitoring allow for identification of training or retraining needs\nas well as training needs regarding protocol amendments or clarification. The\nanalysis may show that many clinical research sites did not think that the\ntraining was clear. A large clarification often requires an amendment.<\/p>\n\n\n\n<p>Equipment issues can be\nidentified through the statistical analyses in centralized monitoring. Many\nstudies involve device diagnostic testing, where sponsors send equipment to the\nclinical research sites. The people at the sites who are using the equipment\nusually have some training in the use of the equipment. The statistical\nanalyses can identify differences in the use of equipment between different\nsites and may indicate that the equipment needs some attention.<\/p>\n\n\n\n<p>The statistical analyses in\ncentralized monitoring can indicate a need to change the monitoring approach or\nrealign staff at clinical research sites. A change in monitoring could be\nvisiting some clinical research sites more often or visiting all sites less\noften. Some sites may need more resources. The sponsor and the CRO can work\nwith sites that need more help to achieve a better way to develop quality data.<\/p>\n\n\n\n<p>When using centralized\nmonitoring, it is important to ensure that the right data are being evaluated.\nDo not evaluate all of the data, which would require a great deal of issue\nmanagement and investigation of false-positives. Focus on the critical data and\navoid data that should be similar. <\/p>\n\n\n\n<p>Performance metrics and\nthresholds should be used. Start small, with 10 to 20 metrics. Add more metrics\nafter staff members have experience using metrics. Over time, the statistical analyses\nwill indicate the most meaningful metrics for the organization. Thresholds for\ntaking action should be set, and the actions to be taken if these thresholds\nare reached should be pre-defined. <\/p>\n\n\n\n<p>Issue management is\nimportant. Sponsors should not have to revisit issues identified in past\nstatistical analyses. Issues should be resolved after they are identified.<\/p>\n\n\n\n<h2><strong>Documentation<\/strong>\n<strong>of Centralized Monitoring<\/strong><\/h2>\n\n\n\n<p>Documentation of centralized\nmonitoring is required (Table 6). Centralized monitoring requires a risk\nmanagement plan, such as TransCelerate\u2019s integrated quality and risk management\nplan. When starting centralized monitoring, it is best to develop a simple risk\nmanagement plan that will work for the company.&nbsp;\n<\/p>\n\n\n\n<p>Documentation also includes evidence\nof adherence to the risk management plan and issue management. Evidence of\nadherence to the plan includes metrics, centralized monitoring reports, and changes\nin thresholds. Issue management documentation includes interpretation of\nresults, investigation of issues, and results of the investigation. Sponsors\noften develop reports to document centralized monitoring.<\/p>\n\n\n\n<h2><strong>Conclusion<\/strong><\/h2>\n\n\n\n<p>Centralized monitoring does\nadd value to clinical trials. Sponsors that have not yet used centralized\nmonitoring should investigate it. Centralized monitoring allows review of data\nin a way that cannot necessarily be done through on-site monitoring. It focuses\non critical data and process and helps sponsors prioritize what should be\nmonitored.<\/p>\n\n\n\n<p>The metrics and statistical\nanalytics used in centralized monitoring are very helpful. Statisticians should\nbe included in discussions about the appropriate metrics and statistical\nanalytics for the study. It is important to choose the right data for analysis\nand to not overanalyze other data. Centralized monitoring should focus on\ncritical study data.<\/p>\n\n\n\n<p>The risk management plan must be followed, and appropriate documentation must be maintained. Documenting issue management is especially important, and it will save time in the future. <\/p>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\n<h2><strong>TABLE 1<\/strong><\/h2>\n\n\n\n<p style=\"text-align:center\"><strong>Integrated\nQuality and Risk Management Plan<\/strong><\/p>\n\n\n\n<ul><li>Define the critical data and processes (what matters)<ul><li>Critical data:<ul><li>Data that support primary and key secondary objectives<\/li><\/ul><\/li><li>Critical processes:<ul><li>Processes that support safety or quality<\/li><\/ul><\/li><\/ul><\/li><li>Implement \u201cquality by design\u201d<\/li><li>Develop an &nbsp;integrated\n     quality and risk management plan:<ul><li>Drives all other plans, especially monitoring plans<\/li><\/ul><\/li><\/ul>\n\n\n\n<h2><strong>TABLE 2<\/strong><\/h2>\n\n\n\n<p style=\"text-align:center\"><strong>The\nMonitoring Plan<\/strong><\/p>\n\n\n\n<ul><li>Expand \u201ctraditional\u201d plan to include:<ul><li>On-site monitoring<\/li><li>Off-site monitoring<\/li><li>Central monitoring<\/li><\/ul><\/li><li>Define risk indicators<\/li><li>Ensure that the escalation path is understood and includes the clinical\n     investigator<\/li><li>Consider differentiating between:<ul><li>Source data verification and source data review <\/li><\/ul><\/li><\/ul>\n\n\n\n<h2><strong>TABLE 3 <\/strong><\/h2>\n\n\n\n<p style=\"text-align:center\"><strong>Centralized\nMonitoring<\/strong><\/p>\n\n\n\n<ul><li>A remote evaluation of the study<\/li><li>Activities:<ul><li>Monitor data quality through review of submitted data to address:<ul><li>Missing and inconsistent data<\/li><li>Data outliers <\/li><li>Potential protocol deviations<\/li><\/ul><\/li><li>Conduct statistical analyses to uncover:<ul><li>Data trends such as range, consistency, and completeness of data\n       <\/li><li>Unusual distribution of data within and between study sites<\/li><\/ul><\/li><li>Analyze site performance metrics to uncover:<ul><li>Poor performance <\/li><li>Noncompliance<\/li><\/ul><\/li><li>Verify critical source data remotely, if possible<\/li><li>Complete administrative and regulatory tasks<\/li><\/ul><\/li><\/ul>\n\n\n\n<h2><strong>TABLE 4<\/strong><\/h2>\n\n\n\n<p style=\"text-align:center\"><strong>Benefits<\/strong> <strong>of Centralized Monitoring\n<\/strong><\/p>\n\n\n\n<ul><li>Identifying areas in the protocol for potential clarification<\/li><li>Identifying indications of data fabrication<\/li><li>Targeting on-site monitoring to higher risk clinical sites<\/li><li>More communication with site staff<\/li><li>More timely verification of informed consent documentation<\/li><li>Focusing on what matters<\/li><\/ul>\n\n\n\n<h2><strong>TABLE 5<\/strong><\/h2>\n\n\n\n<p style=\"text-align:center\"><strong>Statistical\nAnalyses<\/strong><\/p>\n\n\n\n<ul><li>Compares data among patients at clinical research sites and\n     between sites<\/li><li>Looks for similarity of data, trends, outliers, and missing data<\/li><li>Helpful in detecting fraudulent behavior and data<\/li><li>Allows for identification of:<ul><li>Training or retraining needs<\/li><li>Protocol amendment\/clarification needs<\/li><li>Equipment issues<\/li><li>Change in monitoring approach<\/li><li>Staffing re-alignment<\/li><\/ul><\/li><li>Considerations:<ul><li>Typically statistically based:<\/li><\/ul><ul><li>Evaluate critical data<\/li><\/ul><ul><li>Avoid data that should be similar<\/li><\/ul><\/li><\/ul>\n\n\n\n<ul><li>Use performance metrics and thresholds<\/li><li>Manage issues <\/li><\/ul>\n\n\n\n<h2><strong>TABLE 6<\/strong><\/h2>\n\n\n\n<p style=\"text-align:center\"><strong>Documentation\nin Centralized Monitoring<\/strong><\/p>\n\n\n\n<ul><li>Risk management plan <\/li><li>Evidence of plan adherence:<ul><li>Metrics<\/li><li>Centralized monitoring reports<\/li><li>Change in thresholds&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/li><\/ul><\/li><li>Issue management: <ul><li>Interpretation of results<\/li><li>Investigation of issues<\/li><li>Results of investigation<\/li><\/ul><\/li><li>Report<\/li><\/ul>\n\n\n\n<p><strong><br> <\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Joanne Malia Associate Director, Clinical Documentation Management&nbsp;Regeneron Pharmaceuticals Abstract: Regulatory agencies are advocating for sponsors to take risk-based approaches in various clinical trial-related activities, especially in the area of monitoring. Sponsors are looking at and beginning to use centralized monitoring. This article describes centralized monitoring, regulatory and industry expectations and initiatives related to centralized monitoring, &hellip; <\/p>\n<p><a href=\"https:\/\/www.socra.org\/blog\/the-value-of-centralized-monitoring\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">The Value of Centralized Monitoring<\/span> &rarr;<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0},"categories":[15],"tags":[59],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v15.6.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The Value of Centralized Monitoring - SOCRA Blog<\/title>\n<meta name=\"description\" content=\"This article describes centralized monitoring, regulatory and industry expectations and initiatives related to centralized monitoring, the value of centralized monitoring in enhancing data quality in clinical trials, and use and documentation of centralized monitoring.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.socra.org\/blog\/the-value-of-centralized-monitoring\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The Value of Centralized Monitoring - 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