{"id":211,"date":"2019-10-28T21:21:16","date_gmt":"2019-10-28T21:21:16","guid":{"rendered":"https:\/\/www.socra.org\/blog\/?p=211"},"modified":"2020-01-30T18:46:48","modified_gmt":"2020-01-30T18:46:48","slug":"building-a-quality-assurance-program-for-investigator-initiated-trials","status":"publish","type":"post","link":"https:\/\/www.socra.org\/blog\/building-a-quality-assurance-program-for-investigator-initiated-trials\/","title":{"rendered":"Building a Quality Assurance Program for Investigator-initiated Trials"},"content":{"rendered":"\n<p style=\"text-align:center\"><strong>Abby Statler, MPH, MA, CCRP<br>Research Regulatory Quality Assurance Coordinator<br>Cleveland Clinic Cancer Institute<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" loading=\"lazy\" width=\"1024\" height=\"683\" src=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/10\/iStock-1096502340-1024x683.jpg\" alt=\"Two clinical researchers analyzing information on a computer\" class=\"wp-image-213\" srcset=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/10\/iStock-1096502340-1024x683.jpg 1024w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/10\/iStock-1096502340-300x200.jpg 300w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/10\/iStock-1096502340-768x512.jpg 768w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/10\/iStock-1096502340.jpg 1254w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p><strong><em>Abstract<\/em><\/strong><em>:<\/em> In 2008, <em>The <\/em><em>Cleveland\nClinic Cancer Institute established<\/em> <em>a quality assurance (QA) program for investigator-initiated trials\n(IITs). Over the past nine years, the program has become an integral part of\nthe Institute\u2019s research department, supporting the growth of IITs while\nimproving the proficiency of regulatory operations. This article describes the\nprogram\u2019s objectives and discusses the operational strategies employed to\nachieve these goals. Other clinical research sites are encouraged to consider\nhow components of the <\/em><em>Cleveland Clinic Cancer Institute\u2019s QA program may be\nadapted to meet the needs of their organizations. <\/em><em><\/em><br><\/p>\n\n\n\n<h2><strong>Introduction<\/strong><\/h2>\n\n\n\n<p>The\nresearch sponsored by Cleveland Clinic investigators supports the Foundation\u2019s\ninnovation initiatives, making it a top priority for the Institute\u2019s leadership\nteam. Thus, the development and implementation of the Cleveland Clinic Taussig Cancer\nInstitute\u2019s QA program was motivated by the organization\u2019s commitment to effectively\noversee the conduct of IITs. Launched in 2008,\nthe Cancer\nInstitute\u2019s QA program was the first of its kind, specifically focusing on\nproviding operational support for investigator-initiated trials. <\/p>\n\n\n\n<p>Before\nthe department was implemented, investigator-initiated trials had few\noperational resources, protocols required multiple revisions, Investigational\nNew Drug Applications were submitted inconsistently to the U.S. Food and Drug\nAdministration (FDA), and processes for effective essential regulatory\ndocumentation management had not been established. To date, the QA program has grown\nfrom one to five members, which has enabled the department to cohesively\nsupport the IIT profile while also improve the operations of industry-sponsored\nand cooperative group trials. In this article, I will outline the essential\ncomponents of a QA program, discuss the challenges that our department faced\nduring the program\u2019s development, and highlight how the Institute\u2019s commitment\nto quality has enhanced the Cancer Center\u2019s conduct and initiation of clinical\ntrials. <\/p>\n\n\n\n<!--more-->\n\n\n\n<h2><strong>The Profile of\nInvestigator-initiated Research <\/strong><\/h2>\n\n\n\n<p>The\nfirst step in developing a QA program for investigator-initiated trials is to inventory\nand categorize all protocols sponsored by the institution. The profile of this\nresearch must be well understood before the QA program\u2019s objectives can be\nestablished. This was the first challenge our group faced due to the fact that\ninvestigators at the Taussig Cancer Institute were obtaining their own funding\nand writing their own protocols. A central repository for these studies had not\nbeen created. Therefore, the QA group initially focused on determining the\noverall scope of the Institute\u2019s IITs. To accomplish this, the program manager\nreviewed Institutional Review Board records, data mined the Institute\u2019s\ninternal database, and regularly collaborated with research coordinators,\ninvestigators, and program managers. This was an epic task &#8211; it took several\nmonths to complete the comprehensive inventory of the Institute\u2019s IITs. <\/p>\n\n\n\n<h2><strong>Risk Assessment<\/strong><\/h2>\n\n\n\n<p>After the profile of\ninvestigator-initiated research has been established, the next step is to identify\nthe high-risk protocols. Protecting the safety and welfare of the subjects\nenrolled in investigator-initiated\ntrials is paramount; therefore,\nconducting a risk assessment to prioritize oversight is essential. To perform this risk assessment, our QA team developed\nan algorithm to\nidentify those studies that pose the highest risk. The algorithm assigns\ndifferent weights to the study characteristics that are essential to the risk\nevaluation: Investigational New Drug (IND) \/ Investigational Device Exemption\n(IDE) status, number of sites, protocol complexity, study phase, and study team\nexperience. The overall risk score assigned to each study determines its prioritization.\n<\/p>\n\n\n\n<p>To\nbe expected, the trials that pose the most risk involve investigational new\ndrugs and\/or devices (Table 1). However, IND\/IDE exempt trials also top our\ninstitute\u2019s prioritization list. While\nthese studies do not include an investigational product, they still must follow\nthe Common Rule as well as the International Conference on Harmonisation Good\nClinical Practice (ICH GCP) Guideline. Of the IND\/IDE exempt protocols, the\nmulti-site trials are our highest priority. These studies are difficult to\nmanage, specifically because, as the sponsor, Cleveland Clinic is responsible\nfor overseeing the other institutions. Currently, multi-site IND\/IDE-exempt\nstudies receive explicit support from the QA program. We are focusing our\nefforts on providing the study teams with the resources required to effectively\nmanage external institutions.<\/p>\n\n\n\n<p>The lowest risk studies at the Taussig Cancer Institute are non-interventional;\nthese include correlative studies, chart reviews, and studies involving databases\nand repositories. Because many of these studies do not require informed consent,\nthe risk to potential participants is minimized. However, this does not mean that\nthe risk is eliminated. We have discovered that inexperienced researchers fail\nto renew their protocols with the IRB, and in some cases, they violate privacy\nlaws. &nbsp;<\/p>\n\n\n\n<h2><strong>QA Review Scope and Priorities<\/strong><\/h2>\n\n\n\n<p>The\nnext steps in developing a QA program are determining the scope of the QA\nreviews and prioritizing the studies to be reviewed. Reviews should be driven\nby the organization\u2019s risk assessment, focusing the majority of resources\ntowards the high-risk studies. As discussed above, at the Taussig Cancer\nInstitute, the highest priority studies are the INDs\/IDEs, followed by\nmulti-center IND\/IDE-exempt studies (Table 2). These studies are generally monitored every 6-12 weeks. <\/p>\n\n\n\n<p>The\nscope of review depends upon the characteristics of the study. Expectations are\ndocumented in the monitoring plan, which outlines the expectation of the\ninitiation, interim, and close out visits. These reviews typically cover three\nprimary components: subject records, pharmacy operations \/ drug accountability,\nand essential regulatory documents. Quality assessments, however, will not have\nthe scope defined until the study is elected for review. This allows the QA\nteam to tailor these assessments, ensuring that the highest-risk areas for a specific\nstudy are evaluated for compliance. <\/p>\n\n\n\n<h2><strong>Goals and Objectives<\/strong><\/h2>\n\n\n\n<p>Once the IIT profile has been\nestablished and the protocols have been prioritized according to risk, the QA\nteam should determine the program\u2019s goals and objectives. At the Taussig Cancer Institute, the\nprimary goal is to support investigator-initiated trials (Table 2).\nInvestigators have innovative ideas and are experts in their fields; however,\nthey may not fully understand the regulatory expectations. For this reason,\ndeveloping operational support for the research teams is a top priority. Educating\nsponsor-investigators and study coordinators regarding sponsor-specific\nresponsibilities has been a premier aspect of this operational support. Study\ncoordinators, especially those managing multi-site investigator-initiated\ntrials, have indicated that the QA department\u2019s educational initiatives have\nhelped them feel more confident in managing these complex studies. Furthermore,\nthe work of the QA group has enabled study coordinators to better manage their trials,\nimproving the overall efficiency of the department. <\/p>\n\n\n\n<p>The\nprogram\u2019s second goal is to mitigate risk. This is accomplished by actively\nmonitoring studies and consistently reviewing deviations. When an issue is\nidentified, the QA group works diligently to emphasize the importance of root\ncause analysis and corrective action plans \u2013 both of which have been embraced\nby the research teams. Sometimes the same issue occurs across protocols. When\ntrends are identified, the QA group discusses them with the study team(s),\noffering support and guidance regarding the corrective \/ preventative action\nplan. This cohesive process has been instrumental in reducing the number of\nprotocol deviations. <\/p>\n\n\n\n<p>Another\ngoal of the QA program is to facilitate innovation within the institute\u2019s\nresearch program. Administrators at the Taussig Cancer Institute recognize\nthe importance of IITs; therefore, providing investigators with the resources\nto effectively conduct their studies is a top priority. This draws innovative\ninvestigators to the Taussig Cancer Institute\nand supports the ever-growing portfolio of IITs. The operational support that the\nQA program offers has been pivotal to the growth of the program; providing the\nregulatory support required to manage these studies allows investigators to\nfocus their efforts on scientific innovation.<\/p>\n\n\n\n<h2><strong>Performance Metrics<\/strong><\/h2>\n\n\n\n<p>After the program\u2019s goals\nhave been defined, the team should develop performance metrics. Quantifying the\ngroup\u2019s progress is essential for the growth of the program; this ongoing\nevaluation allows the team to determine if the goals and objectives of a QA\nprogram are being met. Performance metrics have been an essential aspect of the\nTaussig Cancer Institute\u2019s QA program: Cleveland Clinic is data-driven. Objectives\nmust be quantifiable, meaningful, and effectively communicated by leadership. <\/p>\n\n\n\n<p>In order to measure the effectiveness\nof the QA program, the group quantifies:<\/p>\n\n\n\n<ul><li>Number of reviews<\/li><li>Monitoring visit frequency compliance<\/li><li>Number of observations.<\/li><\/ul>\n\n\n\n<p>Tracking the number of\nreviews is important; this data has been instrumental in driving the growth of\nour team. If the QA team had not tracked the number of reviews and the amount\nof time spent on them, it is unlikely that the group would have been able to grow at\nan appropriate pace.<\/p>\n\n\n\n<p>Compliance with the\nmonitoring plan is also an essential metric. This allows the group to determine\nits efficiency. If a visit is missed, the monitor must provide an explanation. This\naccountability supports the group\u2019s transparency, a key feature of our QA\nprogram. Furthermore, by tracking compliance with monitoring frequency, the QA\ngroup is able to provide the administration with the data required to determine\nwhether the group\u2019s objectives are being met. <\/p>\n\n\n\n<p>The quantification and\ncategorization of queries is another useful metric. The QA group has a\nspreadsheet that lists the different regulatory documents, organized according\nto Section 8.0 (Essential Regulatory Documentation) of ICH GCP. Each QA\nCoordinator populates this spreadsheet with the data from the respective\nreviews. This process has helped the group identify areas for improvement,\ndrive process improvement initiatives, and guide future educational offerings.\nFor example, after identifying informed consent documentation issues, the QA\ngroup conducted a number of training sessions for the nurses and study\ncoordinators. This lead to a decrease in these observations, indicating that the\ntargeted training initiative was effective. <\/p>\n\n\n\n<h2><strong>The QA Program<\/strong> <strong>Pilot and\nEvaluation<\/strong><strong><\/strong><\/h2>\n\n\n\n<p>Over the past nine years, the\nTaussig Cancer\nInstitute has piloted a variety of program approaches, testing, and evaluations\nof specific review processes. After about two years of working with the administration,\ninvestigators, and study coordinators, the group has developed practices that are\nboth efficient and effective. <\/p>\n\n\n\n<p>The\nQA team\u2019s standardization of the process for developing a monitoring plan is\njust one example of the practices that emerged from the initial piloted efforts\n(Table 3). The process begins with reviewing the protocol and providing\nfeedback to the primary investigator (PI). This initial collaboration has been\nkey to the program\u2019s success &#8211; it allows QA to develop a relationship with the\nPI early on, which is crucial to a successful monitoring program. QA is able to\nprovide feedback to the PI from a compliance perspective, ultimately improving\nquality of the protocol. <\/p>\n\n\n\n<p>The\nnext step involves the review of the database. QA compares the case report\nforms (CRFs) to the protocol to ensure that the appropriate data is being\ncollected and that the structure of the calendar reflects the protocol.\nAdditionally, the CRF instructions are reviewed; it is essential for both the\nmonitor and the study coordinator to have the same expectations regarding data\nentry. Without effective instructions, the consistency \/ accuracy of the data\ncollection may be compromised. <\/p>\n\n\n\n<p>Next,\nQA works with the study coordinator to develop the manual of operating\nprocedures (MOP). The research coordinator creates the initial version and\nsends the document to QA for review. During the review of the MOP, QA\nspecifically ensures that subject registration, drug accountability, and sponsor\ncommunication are explicitly documented. These components of the MOP are\nparticularly important for multi-site studies. <\/p>\n\n\n\n<p>Finally,\nafter the protocol, database, and MOP have been reviewed by QA, the development\nof the monitoring plan can begin. This involves editing the Taussig Cancer\nInstitute\u2019s monitoring plan template to meet the needs of the protocol \u2013 the\nstandardized monitoring components remain consistent across studies while the source\ndata verification section will be unique to each protocol. The draft plan is\nthen sent to the study team for feedback; at this point, QA ensures that they\nhave connected with the appropriate team members. This communication is\nessential, without it, the quality of the monitoring plan could be compromised.\nThe last step in the process involves the final approval by the\nsponsor-investigator. He or she will sign the finalized plan, signaling the\ncompletion of the process. <\/p>\n\n\n\n<p>Another\nexample of the QA program\u2019s evolution has to do with the program\u2019s expectations\nregarding query responses. During the first few years of the program, the study\ncoordinators were required to provide written responses to all regulatory\nqueries. A few years after this requirement became effective, the coordinators\nbegan to argue that they were spending too much time responding to queries;\nthis laborious requirement was not productive, taking time away from their\nability to efficiently address the violations. In response, QA agreed to no\nlonger require responses to the regulatory queries. This demonstrated QA\u2019s\nwillingness to work with the research teams, ultimately strengthening the\ndepartment\u2019s relationship with the institute\u2019s disease groups. After the\nresponse requirement was eliminated, the QA team recognized that the responses\nwere not needed to effectively address violations. In fact, after this\nrequirement had been eliminated, study coordinators had more time to focus on\naddressing the queries themselves (i.e., filing documents, creating notes to\nfile, preparing IRB submissions, etc.). This improved the operational\nefficiency of the department, which was a win for the QA program and the study\nteams.<\/p>\n\n\n\n<h2><strong>Conclusion<\/strong><\/h2>\n\n\n\n<p>Ultimately,\na high-functioning IIT QA program should have the following components: <\/p>\n\n\n\n<ol><li>a risk assessment algorithm<\/li><li>a review prioritization\nstrategy<\/li><li>goals and objectives <\/li><li>performance metrics <\/li><li>a well-defined process for\npiloting quality assurance practices.<\/li><\/ol>\n\n\n\n<p>These\nare the cornerstones of a robust QA program, providing a solid foundation from\nwhich the department can grow. Furthermore, the standardized QA practices must\nbe adaptable; as the research landscape changes, the QA program will need to\nevolve, modernizing the way in which compliance is assessed.<\/p>\n\n\n\n<p>Building\na successful QA Program takes time, trust, and stakeholder support. The\ncultivation of a high-functioning department is a dynamic process; it requires\ncohesive and coordinated efforts from the front line employees to the Chair of\nthe Institute. The success of this collaboration truly depends upon the\nstrength of the stakeholders\u2019 relationships. These relationships, above all\nelse, should not be underestimated.&nbsp; &nbsp;<\/p>\n\n\n\n<p>The development and implementation of the Cleveland Clinic Cancer Institute\u2019s QA program has tested relationships and presented unforeseen challenges. Blazing the trail for this program was not easy; however, each challenge presented an opportunity for growth, allowing the program to mature into a valuable resource for the institute. The QA department is now an integral part of the institute\u2019s research operation, providing essential support for the growing profile of investigator-initiated clinical trials.&nbsp;&nbsp; &nbsp;<\/p>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\n<h2 style=\"text-align:center\"><strong>TABLE 1<\/strong><\/h2>\n\n\n\n<p><strong>Risk\nAssessment for Investigator-initiated Trials at the Taussig Cancer Institute <\/strong><\/p>\n\n\n\n<ul><li>High-risk: <ul><li>IND\/IDE studies<\/li><\/ul><\/li><li>Medium-risk:<ul><li>IND\/IDE exempt studies (specific focus on multi-site trials)<\/li><\/ul><\/li><li>Low-risk:<ul><li>Non-interventional research<\/li><\/ul><\/li><\/ul>\n\n\n\n<h2 style=\"text-align:center\"><strong>TABLE 2<\/strong><\/h2>\n\n\n\n<p><strong>The Taussig\nCancer Institute QA Program\u2019s Objectives<\/strong><\/p>\n\n\n\n<ul><li>Support investigators conducting investigator-initiated trials <\/li><li>Mitigate risk<\/li><li>Reduce deviations<\/li><li>Improve trial management<\/li><li>Facilitate innovation<\/li><li>Expand the investigator-initiated trials program<\/li><\/ul>\n\n\n\n<h2 style=\"text-align:center\"><strong>TABLE 3<\/strong><\/h2>\n\n\n\n<p><strong>Process\nfor Developing a Monitoring Plan at the Taussig Cancer Institute<\/strong><\/p>\n\n\n\n<ul><li>Review the protocol<\/li><li>Review the database<\/li><li>Review the manual of operating procedures<\/li><li>Develop the monitoring plan<\/li><li>Connect with the study team<\/li><li>Solicit feedback and fine-tune the monitoring plan<\/li><\/ul>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>&nbsp;<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Abby Statler, MPH, MA, CCRPResearch Regulatory Quality Assurance CoordinatorCleveland Clinic Cancer Institute Abstract: In 2008, The Cleveland Clinic Cancer Institute established a quality assurance (QA) program for investigator-initiated trials (IITs). Over the past nine years, the program has become an integral part of the Institute\u2019s research department, supporting the growth of IITs while improving the &hellip; <\/p>\n<p><a href=\"https:\/\/www.socra.org\/blog\/building-a-quality-assurance-program-for-investigator-initiated-trials\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Building a Quality Assurance Program for Investigator-initiated Trials<\/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":[48],"tags":[57],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v15.6.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Building a Quality Assurance Program for Investigator-initiated Trials<\/title>\n<meta name=\"description\" content=\"In 2008, The Cleveland Clinic Cancer Institute established a quality assurance (QA) program for investigator-initiated trials (IITs). 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