{"id":806,"date":"2023-12-22T13:11:24","date_gmt":"2023-12-22T18:11:24","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=806"},"modified":"2026-09-09T17:18:46","modified_gmt":"2026-09-09T21:18:46","slug":"qmp","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/quality-improvement\/qmp\/","title":{"rendered":"Quality Management Plan Guidance"},"content":{"rendered":"<p>The central goal of our Quality Management Plan (QMP) guidance is to provide resources that encourage, guide, integrate, and enhance continuous quality improvement for a research site, research program, or department\/division.<\/p>\n<p>This guide on this page is intended to aid investigators and research staff in QMP set-up, implementation, and evaluation and to prioritize areas of potential risk to target.<\/p>\n<p><a class=\"button ghost-button--blue\" href=\"#consultation\">Get a Quality Management Consultation<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The central goal of our Quality Management Plan (QMP) guidance is to provide resources that encourage, guide, integrate, and enhance continuous quality improvement for a research site, research program, or&hellip;<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":5046,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-806","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"Quality Management Plan (QMP) Guidance","subtitle":"","call_to_action":"","hero_image_placement":"no_image","hero_media":"images","hero_pattern_option":"","hero_video":"","hero_external_video_url":"","hero_external_video_title":"","hero_external_video_poster":"","hero_image_landing":"","hero_image_landing_two":"","hero_image_landing_three":"","content_modules":[{"acf_fc_layout":"text","anchor":"qualitymgmt","css_class":"","title":"<h2>What is quality management?<\/h2>","content":"Quality management within a study protocol includes all of the following:\r\n<ol>\r\n \t<li>a well-designed study protocol<\/li>\r\n \t<li>appropriately trained (and dedicated) study team<\/li>\r\n \t<li>appropriately delegated tasks<\/li>\r\n \t<li>study (and site) feasibility<\/li>\r\n \t<li>sufficient monitoring of subject safety<\/li>\r\n \t<li>adequate data monitoring and management. <a href=\"#references\"><sup>[1, 2, 4, 5, 6]<\/sup><\/a><\/li>\r\n<\/ol>\r\nAdditional information is available through the <a class=\"u-link-external\" href=\"https:\/\/ctti-clinicaltrials.org\/our-work\/quality\/quality-by-design\/\">Clinical Trials Transformation Initiative\u2019s (CTTI) Quality by Design Project<\/a> and their <a class=\"u-link-external\" href=\"https:\/\/ctti-clinicaltrials.org\/wp-content\/uploads\/2021\/06\/CTTI_QbD_CTQ_Priniciples_Document.pdf\">'Critical to Quality Factors Principles Document'<\/a>. Local resources pertaining to study design, protocol development, feasibility assessment, study team training, etc. are available on our <a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/\">Resources page<\/a> and through the <a href=\"https:\/\/www.urmc.rochester.edu\/clinical-translational-science-institute.aspx\">Clinical &amp; Translational Science Institute<\/a>.","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"overview","classes":"","title":"<h2>Quality Management Plan overview<\/h2>","description":"","background":"decorative","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"What is a QMP?","icon":"","row_content":"In its most basic form, \u2018quality\u2019 in the conduct of human subject research is defined by the absence of errors. Therefore, a Quality Management Plans (QMP) is a detailed strategy outlining how errors will be identified and assessed during the conduct of a study.<a href=\"#references\"><sup> [1,2] <\/sup><\/a>It is important to remember when developing a QMP that errors range in severity and their potential to introduce risk to subjects (e.g., minor documentation errors versus enrolling subjects without Institutional Review Board [IRB] approval). The goal of a QMP is to assist in conducting high quality research, which is research that protects subjects, is conducted in a compliant manner, and produces \u2018good\u2019 data with reliable conclusions. <a href=\"#references\"><sup>[3]<\/sup><\/a><sup>\r\n<\/sup>\r\n\r\nTraditionally, assessing quality has been reactive; errors are identified and addressed after the fact. The ideal method of quality management is proactive, which involves the study team implementing a process to continuously assess the quality of the research operation by building quality measures into a study during the development stage.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Why have a QMP?","icon":"","row_content":"The increasing complexity of study protocols drives levels of site burden higher and, while causality has not been demonstrated, may adversely affect site performance <a href=\"#references\"><sup>[7]<\/sup><\/a>. Compounding this notion with data demonstrating that common deficiencies identified by the FDA during site inspections have remained unchanged over the past several years <a href=\"#references\"><sup>[6]<\/sup><\/a> further drives the need to put proactive QMP procedures into place.\r\n\r\nAs study protocols become increasingly complex and the requirement for single-IRB review becomes more common, study teams must be vigilant about maintaining the integrity of the study, protecting subjects and ensuring the quality of the data.<a href=\"#references\"><sup>[3, 5, 6]<\/sup><\/a> Neglecting to identify and address errors may compromise study data, put subjects at undue risk, prevent the ability to meet protocol objectives, and put both the Investigator and the institution at risk with federal regulators (OHRP and FDA) and sponsors.\r\n\r\nImplementing a QMP may help a study team to successfully achieve study objectives, while:\r\n<ul>\r\n \t<li>Protecting the health, safety, and welfare of subjects<\/li>\r\n \t<li>Conducting research compliant with federal and state regulations and guidance, institutional policy, ethical principles and standards appropriate for the Principal Investigator\u2019s (PI) discipline, and the study protocol<\/li>\r\n \t<li>Ensuring data accuracy and validity<\/li>\r\n \t<li>Improving site performance<\/li>\r\n \t<li>Mitigating risk to the Investigator, study team, and institution<\/li>\r\n \t<li>Preparing for external quality-related reviews (e.g., FDA inspections or sponsor audits) <a href=\"#references\"><sup>[3, 4, 6]<\/sup><\/a><\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"accordion_new","anchor_id":"implementation","classes":"","title":"<h2>How to implement a QMP<\/h2>","description":"Developing and implementing a QMP can be daunting. The decision to do so should be well thought out and planned in advance. Before diving into the process, consider the following:","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Commitment and resources","icon":"","row_content":"Implementing a QMP will take dedication, time, and resources (resources that may not have originally been budgeted for), but it may ultimately save time and resources by identifying and potentially preventing troubling incidents of non-compliance. The discussion and decision-making to create and implement a QMP should include Investigators, coordinators, and other leadership within the department\/division, as appropriate. Determining the level of leadership support is crucial in the development of a QMP and will guide the scope of the QMP.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"QMP scope","icon":"","row_content":"A QMP can be developed and implemented for a single study, a group of studies similar in nature, or an entire department\/division. Similarly, the review elements and the timing of the review can vary. For example: for a single study, you may decide to review signed consent forms semi-annually; as a department, you may decide to review a random selection of subject files quarterly; or vice versa.\r\n\r\nUltimately, the nature and scope of the QMP(s) you choose to implement will vary based upon needs and resources.\u00a0 If you are new to this process, or have limited resources, try starting with something simple. As the process becomes more familiar and routine, the QMP can be expanded. Keep in mind, to be effective the nature of the QMP must be realistic and work for the study team. Note that additional examples of QMPs are available in the appendices for your consideration.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"QMP process","icon":"","row_content":"Regardless of the nature and scope of your QMP, following the PDCA Cycle (also known as the Deming Cycle) will assist study teams in successful and effective implementation of a QMP. The PDCA Cycle is a model for continuous process improvements consisting of four repetitive steps:\r\n<ul>\r\n \t<li><strong>P<\/strong>lan: Determine what to review, when, how and by whom<\/li>\r\n \t<li><strong>D<\/strong>o: Execute the plan<\/li>\r\n \t<li><strong>C<\/strong>heck: Assess findings and determine appropriate actions<\/li>\r\n \t<li><strong>A<\/strong>ct: Implement correct and preventative actions<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"accordion_new","anchor_id":"","classes":"","title":"<h3>Steps to implementing a QMP<\/h3>","description":"","background":"decorative","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Step 1.A: PLAN \u2013 What to Review?","icon":"","row_content":"<ol>\r\n \t<li>It is important to define the scope of <em>what<\/em> to review (reference <a href=\"#appendixa\">Appendix A<\/a> for examples):\r\n<ul>\r\n \t<li>Do you want to target compliance areas within or across several studies or conduct study-specific audits?<\/li>\r\n \t<li>What regulations and policies are you held to for the specific study?<\/li>\r\n \t<li>Do you want to consider incorporating continuous monitoring into your day-to-day practice?<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>A risk assessment<a href=\"#references\"><sup> [8,9] <\/sup><\/a>is a systematic process of evaluating the potential risks that may be involved in a projected activity or undertaking. Conducting a risk assessment in the context of the research will help to define what to review within your site or study-specific QMP (reference <a href=\"#appendixb\">Appendix B<\/a> for examples). Consider the following for each study to create your QMP:\r\n<ul>\r\n \t<li>Where will quality matter the most or have the greatest impact, especially when considering limited time and resources? E.g., dosing compliance and accountability of the study drug (if the research includes a study drug)<\/li>\r\n \t<li>What specific problems have occurred previously? E,g., prior errors in obtaining consent<\/li>\r\n \t<li>Where is the risk to the subject, the study staff, the institution, and\/or data quality and integrity? E.g., collection of adverse events in a high-risk study<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>For funded trials where an external monitor will be reviewing all of the above elements, a modified review of the following may be adequate. Do not, however, assume external monitors assess and validate every risk area that is important to your site and your subjects; in particular, external monitors are not aware of specific institutional policies.<a href=\"#references\"><sup> [8] <\/sup><\/a>Prospectively identify specific issues within the approved protocol or through study implementation in which compliance may be problematic; put controls in place to assist you to mitigate problems and errors. Based on your risk assessment, identify specific areas to consider:\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/consent\/\">Informed Consent Process<\/a><\/li>\r\n \t<li>Subject Eligibility<\/li>\r\n \t<li>Protocol Adherence<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/data-safety-monitoring-plans\/\">Data and Safety Monitoring Plan (DSMP)<\/a>, including adverse event identification, collection, reporting, and any other protocol-defined events of clinical interest<\/li>\r\n \t<li>Other Regulatory Expectations:\r\n<ul>\r\n \t<li>Appropriate\/continued delegation of tasks<\/li>\r\n \t<li>Investigational drugs\/devices accountability and related regulatory reporting requirements<\/li>\r\n \t<li>General data quality (is the data attributable, legible, contemporaneous, and complete, original, and accurate?) <a href=\"#references\"><sup>[10]<\/sup><\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Consider repeating your risk assessment during the trial as unexpected events may occur. Be sure to disseminate the risk assessment results to the study team and discuss potential QMP adjustments.<\/li>\r\n \t<li>Additional Points:\r\n<ul>\r\n \t<li>Verification of Data: A process that checks for accuracy and inconsistencies after data collection is done.\u00a0 A best practice may involve a second person verifying data entries.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/study-documentation\/gdp\/\">Good Documentation Practice<\/a>:\r\n<ul>\r\n \t<li>Use of controls\/processes to prevent the inadvertent use of outdated documents<\/li>\r\n \t<li>Clear, legible, indelible handwriting<\/li>\r\n \t<li>No entry space left empty (empty = not done)<\/li>\r\n \t<li>Page numbering; version dates<\/li>\r\n \t<li>Consistent time and date formatting (i.e., military time and date)<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Regulatory Documentation: Written or electronic documents which demonstrate adherence to IRB approved protocol\/amendment(s), IRB requirements, Good Clinical Practice, institutional policy, in accordance with applicable federal regulations, the Food and Drug Administration (FDA), and under the University\u2019s Federal Wide Assurance (45 CFR 46). Necessary documentation items are detailed in the <a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2025\/06\/Site-File-Contents-Description-13JUN2025.pdf\">Research Study Site File Documentation Requirements<\/a>.<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ol>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Step 1.B: PLAN \u2013 When to Conduct QMP Reviews?","icon":"","row_content":"Deciding the frequency of conducting your audits is dependent on several things: identified risks, findings from previous audits, staff turnover, significant changes in regulations, policies, or processes, availability of resources, and breadth and complexity of the protocol\/study. Resources should be allocated specifically naming who is responsible for what with a due date assigned.<a href=\"#references\"><sup> [8, 11]<\/sup><\/a>\r\n\r\nAfter some experience with your QMP, you\u2019ll get a feel for which areas of your operation are prone to problems and would benefit from more frequent audits. The flipside, of course, is that there may be processes in your department that run smoothly and will not derive a benefit from frequent audits. The audit schedule can be revised as your process develops but be aware when your QMP plan is contained in the protocol, a revision may require a protocol amendment.\r\n\r\nOngoing application of your QMP and audit follow-up:\r\n<ul>\r\n \t<li>For non-compliance and internal control deficiencies, monitor timely completion of corrective action.<\/li>\r\n \t<li>For audits that identified major issues, schedule follow-up re-review at a specific point in time (e.g., 6 months after audit).<\/li>\r\n \t<li>Routine monitoring: Include research-related audits on your annual audit plan.<\/li>\r\n \t<li>If you have \u2018an event\u2019 of significant non-compliance, conduct a root cause analysis and revisit your QMP.<\/li>\r\n<\/ul>\r\nSchedule an annual review of your QMP to review prior year results to determine the upcoming year\u2019s QMP.\r\n\r\n<strong>Examples for when to conduct reviews and review strategy:<\/strong>\r\n<ul>\r\n \t<li>Consenting, Eligibility, and Adverse Events\r\n<ul>\r\n \t<li>Review the signed consent, eligibility, and adverse events in the first enrolled subject and subsequently every fifth enrolled subject<\/li>\r\n \t<li>Review 2 subject charts per month<\/li>\r\n \t<li>Review every signed consent plus eligibility plus adverse events (80% review)<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Protocol adherence\r\n<ul>\r\n \t<li>Review the data and safety monitoring plan annually or quarterly dependent on timing defined in approved plan<\/li>\r\n \t<li>Review a specific component of the protocol after each subject is enrolled (i.e. height, weight, blood pressure collected)<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Regulatory Documentation\r\n<ul>\r\n \t<li>Review all regulatory documentation prior to enrolling the first subject and annually (perhaps with Continuing Review)<\/li>\r\n \t<li>Use a checklist to confirm proper filing of regulatory documents with each modification<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Step 2.A: DO \u2013 How to Conduct QMP Reviews?","icon":"","row_content":"Once you\u2019ve decided what to review and when to conduct reviews:\r\n<ul>\r\n \t<li>Create site or study-specific documents and\/or tools. What you decide to review will determine what you use, e.g. Microsoft Word, Excel spreadsheet, Access database, or a RedCap data collection form. Explore our <a href=\"https:\/\/www.rochester.edu\/ohsp\/templates\/#selfaudit\">self-audit tools<\/a>.<\/li>\r\n \t<li>Discuss the site-specific QMP with the study team; provide education as needed<\/li>\r\n \t<li>Allocate a specific time on the calendar at regular intervals to conduct the audits<\/li>\r\n \t<li>Have resources available, e.g. study protocol, regulations, policies<\/li>\r\n \t<li>Select a sample population to audit specific compliance components (i.e. square root + 1)<\/li>\r\n \t<li><strong>Execute the plan<\/strong>: conduct the audit(s)<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Step 2.B: DO \u2013 Who should conduct QMP Reviews?","icon":"","row_content":"To be effective, QMP reviews need to be objective and therefore, it may be best for someone independent from the study team to conduct the review when possible (or at least, as independent as possible). Options include:\r\n<ul>\r\n \t<li>Partnering with another investigator or coordinator within your department\/division to conduct each other\u2019s reviews<\/li>\r\n \t<li>Partnering with another investigator or coordinator external to your department\/division to conduct each other\u2019s reviews (see note below)<\/li>\r\n \t<li>Having senior level or back-up coordinator conduct reviews<\/li>\r\n<\/ul>\r\nWhen determining who will conduct QMP reviews you may want to consider the reviewer\u2019s level of experience in conducting research. While new study personnel should be exposed to the process, collaborating with experienced personnel will provide them more insight to the review process. Furthermore, if you are working within the scope of a department\/division (versus within the scope of a specific study), it may also be helpful to designate a \u2018QMP Leader\u2019; someone whose responsibility could include leading the study team in developing the QMP and assigning QMP-related tasks. Of course, these individuals should always work with the Investigator and the research team to develop and execute the QMP.\r\n\r\nIf review by an independent individual or experienced personnel isn\u2019t possible or there is no designated QMP Leader, don\u2019t let that deter you from implementing a QMP. You will still benefit from conducting your own internal reviews\u2013just be sure to <a href=\"#consultation\">seek advice<\/a> when you need it!\r\n<h5>QMP training<\/h5>\r\nIf necessary, an essential step to take before implementing the plan is training the staff who will conduct reviews.\u00a0As the study team should be involved in the development of the QMP, they should require minimal training. If using a QMP is unfamiliar for a study team, OHSP Division of Quality Improvement (OHSP-QI) is <a href=\"#consultation\">available for consultation<\/a>. OHSP-QI will provide on-site consultation to research team members regarding implementing a QMP specific to their study.\r\n<h6>Proactive strategies to consider<\/h6>\r\n<ul>\r\n \t<li>Present and\/or coordinate educational sessions<\/li>\r\n \t<li>Create and distribute tip sheets on how to avoid compliance issues<\/li>\r\n \t<li>Make tools and resources accessible to facilitate compliance<\/li>\r\n \t<li>Demonstrate compliance\/audit function<\/li>\r\n \t<li>Be available for and willing to answer questions and serve as a resource<\/li>\r\n \t<li>Attend clinical staff and researcher lab meetings to reinforce plan and clarify any misconceptions<\/li>\r\n \t<li>Regular\/routine audits: Make them a part of the day-to-day operations.<\/li>\r\n<\/ul>\r\n<h5>Reporting findings<\/h5>\r\n<ul>\r\n \t<li>Have an understanding in place prior to the review to address what the escalation process is for findings.<\/li>\r\n \t<li>Always report findings to the Principal Investigator and the primary Study Coordinator.<\/li>\r\n \t<li>In some cases, it may be necessary to report findings to Research\/Department Administrator or Supervisor\/Manager if there are safety concerns or serious deficiencies noted.<\/li>\r\n<\/ul>\r\n<strong>Note:<\/strong> As part of the 天美传媒\u2019s Human Research Protection Program, staff are obligated to protect the rights, dignity, welfare, and privacy of research subjects by adhering to the highest ethical standards and to comply with applicable federal and state regulations, as well as institutional policies. As such, staff conducting QMP related reviews must be cognizant of protecting the privacy and confidentiality of the information reviewed, as well as reporting requirements required by the Reviewing IRB. Study teams choosing to partner with staff in other departments should have frank discussions about the management of review findings, prior to entering into such a relationship. Additional information regarding the management of review findings is available in the section below","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Step 3: CHECK \u2013 How to Address and Manage QMP Review Findings?","icon":"","row_content":"<ul>\r\n \t<li>Discuss the findings with the Investigator and study team members<\/li>\r\n \t<li>Assess the scope and source of the problem<\/li>\r\n \t<li>Determine needed actions and develop a response<\/li>\r\n<\/ul>\r\nConsider the following: Is this a \u2018minor\u2019 or \u2018major\u2019 finding (see examples below)? Are vulnerable populations involved? Was the finding a one-time error or is it widespread? What is the source of the error? Is the error the result of a flaw in the process or was it due to lack of oversight? If it was widespread, are there trends in timing, across study personnel, or with a specific process?\r\n<h6>'Minor' examples<\/h6>\r\n<ul>\r\n \t<li>Used pencil to sign consent<\/li>\r\n \t<li>Did not correct a cross out<\/li>\r\n \t<li>Misdated an event on a case report form<\/li>\r\n \t<li>Missing IRB approval documentation<\/li>\r\n<\/ul>\r\n<h6>'Major' examples<\/h6>\r\n<ul>\r\n \t<li>Issue that potentially impacts subject safety, e.g., failure to assess an adverse event<\/li>\r\n \t<li>Missing documentation of consent<\/li>\r\n \t<li>Enrolled an ineligible subject<\/li>\r\n \t<li>Failed to complete study procedures, as defined by the protocol<\/li>\r\n \t<li>Inadequate investigational product accountability<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Step 4.A: ACT \u2013 Determine an Appropriate \u2018Fix\u2019","icon":"","row_content":"Based on the scope and source of the error, develop an appropriate corrective and\/or preventative action. At a minimum, all errors require a corrective action. Preventative actions should also be considered when there are systematic or process-related issues, multiple \u2018minor\u2019 errors that are similar in nature are identified, or a single but significant incident of non-compliance occurs.\r\n<h6>'Immediate Fix' (Corrective Action)<\/h6>\r\n<ul>\r\n \t<li>Correct the immediate problem<\/li>\r\n \t<li>Document what the finding was, what caused the error and what was done to resolve the issue (e.g., documentation, notification to PI\/subject\/study team, data corrections)<\/li>\r\n \t<li><strong>Example<\/strong>: A note to file was created, signed and dated to clarify that the SF-36 measure was not completed during Study Visit 2, as the subject refused.<\/li>\r\n<\/ul>\r\n<h6>'Big-Picture Fix' (Preventative Action)<\/h6>\r\n<ul>\r\n \t<li>Prevent re-occurrence of the problem<\/li>\r\n \t<li>Document the solution that will be used to address the source of the problem. Be specific; use a simple, sustainable, and measurable solution (e.g., process change, re-training, protocol\/CRF revisions. Note that while re-training may be helpful in some cases, it is not always effective as a standalone measure.)<\/li>\r\n \t<li><strong>Example<\/strong>: A secondary study coordinator will cross-check regulatory files annually, at the time of continuing review.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Step 4.B: ACT \u2013 Determine When to Report to the IRB","icon":"","row_content":"For studies reviewed and approved by the Institutional Review Board (IRB), reference the <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_801_Reporting_Research_Events.pdf\">OHSP Policy 801: Reporting Research Events<\/a> and the associated <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/801a_GDL_Reporting_Research_Events.pdf\">Guideline for Reporting Research Events<\/a>. Does the finding involve increased risk to subjects or others (serious, related and unanticipated)?\r\n<ul>\r\n \t<li>If yes, report the event to the IRB within 10 business days<\/li>\r\n \t<li>If no, report the event in summary at the time of continuing review<\/li>\r\n<\/ul>\r\nFor studies reviewed and approved by an External Reviewing IRB (e.g., WCG, another independent IRB, or institutional IRB), report per their reporting policies\/standards.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Step 4.C: ACT \u2013 Implement the Corrective and Preventative Action Plan","icon":"","row_content":"Implement the corrective and preventative action plan. The plan should be implemented in a timely manner and demonstrated via your study documentation.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Step 4.D: ACT & PLAN \u2013 Re-Evaluate the Preventative Action Measures","icon":"","row_content":"If a preventative action measure was implemented, re-evaluate the measure to determine whether it\u2019s been effective at addressing the original error.\r\n<ul>\r\n \t<li>Identify the specific strengths and weaknesses in current practice. Note what is working and what needs to be addressed.<\/li>\r\n \t<li>Additional considerations:\r\n<ul>\r\n \t<li>Create a database of findings ether in excel spreadsheet or REDCap.<\/li>\r\n \t<li>Maintain a yearly departmental summary of findings for leadership and resources to aid in compliance for each finding.<\/li>\r\n \t<li>Use the data to feed into protocol design and to monitor quality.<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>\u2018When things go wrong, which they will do on occasion\u2019\u2026 use the resources available including your <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/coordinator\/\">IRB Coordinator<\/a>, <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_801_Reporting_Research_Events.pdf\">OHSP Policy 801: Reporting Research Events<\/a>, the University integrity hotline (585-756-8888), or other monitoring body (e.g. sponsor\/monitor).<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"tips","css_class":"","title":"<h2>Tips and keys to success<\/h2>","content":"<h4>Advice from the front line<\/h4>\r\n<ul>\r\n \t<li>Start small and basic, build on your QMP when\/if you can.<\/li>\r\n \t<li>Get advice from OHSP-QI when you need it; no question is too small. Contact us at <a href=\"mailto:ohspqi@urmc.rochester.edu\">ohspqi@urmc.rochester.edu<\/a>, or <a href=\"#consultation\">reach out for a consultation<\/a>.<\/li>\r\n \t<li>Consider compiling findings into a database (i.e. Access, Excel, REDCap) to look for trends\/issues in a study or department.<\/li>\r\n \t<li>Be sure the entire study team is aware of the process and expectation. For example, if a newly hired coordinator\u2019s study is always reviewed within a set amount of time, make sure the expectation is known upon hire\/during orientation.<\/li>\r\n \t<li>Consider scheduling a time with the study team for everyone to conduct reviews. If everyone has QA meeting on their calendar once a month, then everyone has a designated time to complete their reviews.<\/li>\r\n \t<li>Meet with the entire study team to review the QMP (annually or quarterly).<\/li>\r\n<\/ul>\r\n<h4>Keys to success<\/h4>\r\n<ul>\r\n \t<li>Investigator and study team commitment.<\/li>\r\n \t<li>Senior leadership commitment.<\/li>\r\n \t<li>Allow the QMP to evolve as needed to reflect internal and external changes; continuous review of the QMP is important in relation to organizational\/departmental changes.<\/li>\r\n \t<li>Have a vision for a \u2018quality culture\u2019 by working together to encourage honest communication, increase knowledge, correct problems and learn from mistakes.<\/li>\r\n<\/ul>","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"text","anchor":"consultation","css_class":"title-line t-yellow t-below","title":"<h2>Reach out: Consultations and support<\/h2>","content":"OHSP-QI offers free Quality Management Consultations to assist teams in planning QMPs. As part of the consultation, OHSP-QI will:\r\n<ul>\r\n \t<li>Evaluate the study protocol(s);<\/li>\r\n \t<li>Collaborate with the study team to brainstorm efficient and effective means to mitigate errors;<\/li>\r\n \t<li>Ensure the study team understands the regulations, policies, and guidance that applies to the research; and<\/li>\r\n \t<li>Provide educational materials\/references, support, study tools, and a post-consultation written assessment.<\/li>\r\n<\/ul>\r\nConsultations can be requested any time during the study life cycle and are customizable to study team needs. To request a consultation, email <a href=\"mailto:ohspqi@urmc.rochester.edu\">ohspqi@urmc.rochester.edu<\/a>.\r\n\r\nYou can also <a href=\"mailto:ohspqi@urmc.rochester.edu\">email our team<\/a> with any questions or for additional guidance.\r\n\r\n<a class=\"button ghost-button--blue\" href=\"mailto:ohspqi@urmc.rochester.edu\">Reach out to our team<\/a>\r\n\r\n<hr \/>","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"references","classes":"pb-0 pt-0","title":"<h2>References and appendices<\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"References","icon":"","row_content":"<ol>\r\n \t<li>Landray, M., Grandinetti, C., Kramer, J., Morrison, B., Ball, L., &amp; Sherman, R. (2012). Clinical Trials: Rethinking How We Ensure Quality.\u00a0 Drug Information Journal, 46(6), 657-660. Retrieved September 16, 2015 from <a href=\"https:\/\/journals.sagepub.com\/doi\/abs\/10.1177\/0092861512464372\">Sage Journals<\/a><\/li>\r\n \t<li>Sprenger, K., Nickerson, D., Meeker-O\u2019Connell, A. &amp; Morrison, B. (2012). Quality by Design in Clinical Trials:\u00a0 A Collaborative Pilot with FDA. Therapeutic Innovation &amp; Regulatory Science, 47(2), 161-166. Retrieved September 16, 2015 from <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/30227529\/\">PubMed<\/a><\/li>\r\n \t<li>Clinical Trials Transformation Initiative (CTTI). (2015, May 19).\u00a0 \u201cCTTI Quality by Design Project \u2013 Critical to Quality (CTQ) Factors Principles Document\u201d.\u00a0 Retrieved September 14, 2015 from <a href=\"https:\/\/ctti-clinicaltrials.org\/wp-content\/uploads\/2021\/06\/CTTI_QbD_CTQ_Priniciples_Document.pdf\">CTTI<\/a><\/li>\r\n \t<li>Clinical Trials Transformation Initiative (CTTI). (2015, May 19).\u00a0 \u201cQuality by Design Project Summary\u201d.\u00a0 Retrieved April 1, 2016 from <a href=\"https:\/\/ctti-clinicaltrials.org\/our-work\/quality\/quality-by-design\/\">CTTI<\/a><\/li>\r\n \t<li>Alemayehu, D., Alvir, J., Levenstein, M., &amp; Nickerson, D. (2013, Oct-Dec). A data-driven approach to quality risk management. Perspectives in Clinical Research, 4(4), 221-226. Retrieved September 16, 2015 from <a href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3835966\/\">National Library of Medicine<\/a><\/li>\r\n \t<li>Bhatt, A. (2011, Oct-Dec). Quality of clinical trials:\u00a0 A moving target. Perspectives in Clinical Research, 2(4), 124-128.\u00a0 Retrieved March 29, 2016 from <a href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3227329\/\">National Library of Medicine<\/a><\/li>\r\n \t<li>Getz, K. (2008, May). Protocol Design Trends and their Effect on Clinical Trial Performance. RAJ Pharma, 4(4), 221-226. Retrieved March 30, 2016 from <a href=\"https:\/\/www.researchgate.net\/publication\/285473087_Protocol_design_trends_and_their_effect_on_clinical_trial_performance\">Tufts<\/a><\/li>\r\n \t<li>Campbell, J. (2012) Developing Monitoring and Auditing Programs for Clinical Research. Retrieved April 1, 2016 from <a href=\"https:\/\/www.hcca-info.org\/\">HCCA<\/a><\/li>\r\n \t<li>The Guidance for Industry \u2013 Quality Risk Management (2006, June). Retrieved April 1, 2016 from <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q9r1-quality-risk-management\">FDA<\/a><\/li>\r\n \t<li>The Guidance for Industry \u2013 Computerized Systems Used in Clinical Trial (1999, April). Retrieved May 1, 2016 from <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/fda-bioresearch-monitoring-information\/guidance-industry-computerized-systems-used-clinical-trials\">FDA<\/a><\/li>\r\n \t<li>The National Computing Centre Limited (1996, July 31). Internal Quality Audits: What They Are and How to Carry Them Out.\u00a0 Internal Quality Audits Issue 2. Retrieved April 1, 2016 from <a href=\"http:\/\/www.tarrani.net\/linda\/docs\/InternalQualityAudits.pdf\">Tarrini<\/a><\/li>\r\n<\/ol>","accordion_anchor":""}]},{"acf_fc_layout":"accordion_new","anchor_id":"appendixa","classes":"","title":"<h3><strong>Appendix A \u2013 QMP Examples<\/strong><\/h3>","description":"Below are examples or \u2018food for thought\u2019 to stimulate ideas and direction for individual site QMP development. Each scenario provides an example of what <em>could<\/em> be reviewed with limited QMP resources (e.g., time) versus a more comprehensive review. Keep in mind, these examples are not all-inclusive. You may, at any time, review any or all subjects and\/or all data collection forms for protocol compliance.","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Greater than minimal risk behavioral research","icon":"","row_content":"<h6>Protocol summary\/scenario<\/h6>\r\nAn Investigator-initiated, randomized, multi-center study of cognitive therapy with or without mindfulness training in adults (age 18 and older) with depression and history of suicidal ideation. Subjects are to be meditation-na\u00efve for the previous six months per subject report. All enrolled subjects attend one study visit each week for four weeks, followed by every other week (+\/- three business days) for 20 weeks. Each study visit includes a standard cognitive therapy session and questionnaire completion (including depression, suicidal ideation, and quality of life measures); duration of each study visit is expected to be one hour. Subjects randomized to receive mindfulness training complete additional training for the first eight weeks (duration of the additional training is 30 minutes each week); they will also maintain and submit mediation online diaries weekly. Approximately 100 subjects (randomized 1:1) are expected to enroll. All adverse events, depression, and suicidal ideation scales will be monitored by the Investigator at the time of each study visit. The Data and Safety Monitoring Committee will review comprehensive adverse event data annually.\r\n<h6>Limited resources QMP example<\/h6>\r\n<ol>\r\n \t<li>Review the <strong>regulatory file<\/strong> for completeness once annually with Continuing Review.<\/li>\r\n \t<li>Review the <strong>signed consent<\/strong> for the first enrolled subject and subsequently for every fifth enrolled subject. Review consent forms for:\r\n<ol>\r\n \t<li>Watermark and letterhead present<\/li>\r\n \t<li>Account for all consent pages<\/li>\r\n \t<li>Option section(s) completed<\/li>\r\n \t<li>Signature dates congruent<\/li>\r\n \t<li>Original signatures in indelible ink<\/li>\r\n \t<li>IRB-approved staff obtained consent<\/li>\r\n \t<li>Watermark valid (not expired)<\/li>\r\n \t<li>Version correct<\/li>\r\n<\/ol>\r\n<\/li>\r\n<\/ol>\r\n<h6>Comprehensive QMP example<\/h6>\r\n<ol>\r\n \t<li>Complete the review of all 'limited resource' items (section above) plus <strong>review eligibility<\/strong>, <strong>adverse events<\/strong>, and <strong>protocol adherence<\/strong> in the first enrolled subject and every fifth enrolled subject.<\/li>\r\n \t<li>Review the <strong>eligibility<\/strong> documentation for:\r\n<ol>\r\n \t<li>Adherence to the approved inclusion\/exclusion criteria<\/li>\r\n \t<li>Investigator signature and date, as applicable<\/li>\r\n \t<li>Accuracy of eligibility decision, e.g. calculate date of birth for age range noted in protocol (age 18 and older), correct and documented diagnosis (depression and history of suicidal ideation), and meditation-na\u00efve for previous six months.<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t<li>Review documentation for the assessment of <strong>adverse events<\/strong>, signature of Investigator, and date, as applicable.\r\n<ol>\r\n \t<li>If present, are the events reviewed?<\/li>\r\n \t<li>If reportable, have they been reported to the IRB per reporting policy?<\/li>\r\n \t<li>What follow up was provided to the subject?<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t<li><strong>Protocol Adherence:<\/strong>\r\n<ol>\r\n \t<li>The Data and Safety Monitoring Committee annual meeting summary reports should be present in the regulatory file. Best practice: The Investigator signed and dated when reviewed.<\/li>\r\n \t<li>Review 100% of the suicidal ideation measures for completion and \u2018red flags\u2019 requiring further follow-up.<\/li>\r\n<\/ol>\r\n<\/li>\r\n<\/ol>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Greater than minimal risk biomedical research","icon":"","row_content":"<h6>Protocol summary\/scenario<\/h6>\r\nAn Investigator-initiated, single-center, open-label study of DrugABC used in children age 14-17 with uncontrolled seizures (minimum of twice daily for previous four weeks).\u00a0 An Investigational New Drug (IND) application has been filed with the Food and Drug Administration (FDA) for this study; while DrugABC is FDA approved, it has not been approved for use in this population. Enrolled subjects are DrugABC-na\u00efve, undergo a screening visit, and 13 additional monthly (+\/- four business days) study visits that include a physical examination, vital signs, clinical labs, 24-hour EEG monitoring, and a pain assessment questionnaire.\u00a0 The Data and Safety Monitoring Plan includes: collecting information on all adverse events; reporting adverse events deemed serious to a Medical Monitor within 24 hours of notification, and Data and Safety Monitoring Committee (DSMC) reviews every six months. The subject\u2019s signed informed consent will be scanned into the electronic health record.\u00a0 Registration with <a class=\"u-link-external\" href=\"https:\/\/clinicaltrials.gov\/ct2\/manage-recs\/fdaaa\">clinicaltrials.gov<\/a> is expected.\u00a0 Approximately five subjects are expected to enroll.\r\n<h6>Limited resources QMP example<\/h6>\r\n<ol>\r\n \t<li>Review the <strong>regulatory file<\/strong> for completeness once annually with Continuing Review. Ensure registration is complete and up-to-date for <a class=\"u-link-external\" href=\"https:\/\/clinicaltrials.gov\/ct2\/manage-recs\/fdaaa\">clinicaltrials.gov<\/a>.<\/li>\r\n \t<li>Ensure the following items are maintained for the IND:\r\n<ul>\r\n \t<li>The original FDA IND safe-to-proceed letter receipt<\/li>\r\n \t<li>Annual FDA reports<\/li>\r\n \t<li>The original FDA IND application and submitted amendments<\/li>\r\n \t<li>Safety reports, submitted and reviewed by the Investigator, as applicable<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Review the <strong>signed consent<\/strong> for each enrolled subject. Review the consent forms for:\r\n<ul>\r\n \t<li>Watermark and letterhead present<\/li>\r\n \t<li>Account for all consent pages<\/li>\r\n \t<li>Option section(s) completed<\/li>\r\n \t<li>Signature dates congruent<\/li>\r\n \t<li>Original signatures in indelible ink<\/li>\r\n \t<li>IRB-approved staff obtained consent<\/li>\r\n \t<li>Watermark valid (not expired)<\/li>\r\n \t<li>Version correct<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ol>\r\n<h6>Comprehensive QMP example<\/h6>\r\n<ol>\r\n \t<li>Complete the review of <strong>all 'limited resource' items<\/strong> (above) plus <strong>review eligibility<\/strong>, <strong>adverse events<\/strong>, and <strong>protocol adherence<\/strong> for each enrolled subject<\/li>\r\n \t<li>Review the <strong>eligibility<\/strong> documentation for:\r\n<ol>\r\n \t<li>Adherence to the approved inclusion\/exclusion criteria<\/li>\r\n \t<li>Investigator signature and date, as applicable<\/li>\r\n \t<li>Accuracy of eligibility decision, e.g. calculate date of birth for age range noted in protocol (age 14-17), correct and documented diagnosis (uncontrolled seizures minimum of twice daily for previous month), and DrugABC-na\u00efve.<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t<li>Review documentation for the assessment of <strong>adverse events<\/strong>, signature of Investigator, and date, as applicable.\r\n<ol>\r\n \t<li>If present, are the events reviewed by the Investigator?<\/li>\r\n \t<li>If reportable, have they been reported per IRB policy?<\/li>\r\n \t<li>What follow up was provided to the subject?<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t<li><strong>Protocol Adherence<\/strong>:\r\n<ol>\r\n \t<li>Review the 24-hour EEG monitoring for each enrolled subject i.e.: completion, time points, events\/findings requiring follow-up, Investigator signature and date.<\/li>\r\n \t<li>Data and Safety Monitoring Committee meeting summary reports should be present in the regulatory file from the biannual review. Best practice: Investigator to sign and date when reviewed.<\/li>\r\n \t<li>Electronic Health Record (EMR): Does the site have IRB-approval to include specific research study components in the EMR? Are the results of research testing, the signed consent form, documentation of study participation, or other approved items in the subject\u2019s EMR?<\/li>\r\n<\/ol>\r\n<\/li>\r\n<\/ol>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Minimal risk research","icon":"","row_content":"<h6>Protocol summary\/scenario<\/h6>\r\nAn Investigator-initiated study examining sleep habits in medical residents. Upon enrollment, all subjects complete a demographic questionnaire, a functional magnetic resonance imaging (fMRI) scan, and undergo an overnight sleep study. Subjects will be notified via email every other month to complete questionnaires and cognitive testing online.\u00a0 Repeat overnight sleep studies will be completed every six months and a repeat fMRI scan will be completed annually. Any study related activity has a +\/- 21-day window for completion.\u00a0 Subjects remain enrolled in the research for up to five years or until they complete their medical residency. Final results from the fMRI and overnight sleep studies are reviewed within two weeks by the Investigator; notable results are referred to the subject\u2019s private physician, as appropriate. Approximately 90 subjects are expected to enroll.\r\n<h6>Limited resources QMP example<\/h6>\r\n<ol>\r\n \t<li>Review the <strong>regulatory file<\/strong> for completeness once annually with Continuing Review.<\/li>\r\n \t<li>Review the <strong>signed consent<\/strong> in the first enrolled subject and subsequently every fifth enrolled subject. Review the consent forms for:\r\n<ul>\r\n \t<li>Watermark and letterhead present<\/li>\r\n \t<li>Account for all consent pages<\/li>\r\n \t<li>Option section(s) completed<\/li>\r\n \t<li>Signature dates congruent<\/li>\r\n \t<li>Original signatures in indelible ink<\/li>\r\n \t<li>IRB-approved staff obtained consent<\/li>\r\n \t<li>Watermark valid (not expired)<\/li>\r\n \t<li>Version correct<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ol>\r\n<h6>Comprehensive QMP example<\/h6>\r\n<ol>\r\n \t<li>Complete the review of <strong>all 'limited resource' items<\/strong> (above) plus review <strong>protocol adherence<\/strong> for each enrolled subject.<\/li>\r\n \t<li><strong>Protocol adherence:<\/strong> Review for completeness the demographic questionnaire at screening, the repeat overnight sleep studies every six months, and the repeat fMRI scans annually. Review to confirm the final results from the fMRI and overnight sleep studies are reviewed and any follow-up is initiated within two weeks by the Investigator; best practice, signed and dated by the Investigator\/designee. Report adverse\/research events and consenting issues to the IRB.<\/li>\r\n<\/ol>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"appendixb","css_class":"pt-0 ","title":"<h3>Appendix B: Risk Assessment Examples<\/h3>","content":"Reference the table below for issues and associated risk levels.\r\n[ninja_tables id=\"1256\"]","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"interstitial","anchor_id":"","classes":"","layout":"layout_inline","lead-in":"reach out","title":"Additional support","content":"If you still have questions, need additional support, or would like to request a consultation, email us at <a href=\"mailto:ohspqi@urmc.rochester.edu\">ohspqi@urmc.rochester.edu<\/a>.","call_to_action":{"title":"Contact us","url":"mailto:ohspqi@urmc.rochester.edu","target":""},"bg_color":"#00205b"},{"acf_fc_layout":"card_grid","anchor":"","css_class":"","title":"<h2 style=\"text-align: center;\">Related resources<\/h2>","description":"","background_color":"#FFFFFF","width":"width-large","columns":"2","cards":[{"card_title":"<h5>Study documentation templates<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"Templates","url":"https:\/\/www.rochester.edu\/ohsp\/templates\/#studydocumentation","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Self-audit templates<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"Templates","url":"https:\/\/www.rochester.edu\/ohsp\/templates\/#selfaudit","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Quality Management Plan Guidance - Office for Human Subject Protection - 天美传媒<\/title>\n<meta name=\"description\" content=\"Quality Management Plan (QMP) overview, steps for implementation, and consultations for the 天美传媒 research community.\" \/>\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.rochester.edu\/ohsp\/quality-improvement\/qmp\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Quality Management Plan Guidance - Office for Human Subject Protection - 天美传媒\" \/>\n<meta property=\"og:description\" content=\"Quality Management Plan (QMP) overview, steps for implementation, and consultations for the 天美传媒 research community.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rochester.edu\/ohsp\/quality-improvement\/qmp\/\" \/>\n<meta property=\"og:site_name\" content=\"Office for Human Subject Protection\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-09T21:18:46+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/quality-improvement\\\/qmp\\\/\",\"url\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/quality-improvement\\\/qmp\\\/\",\"name\":\"Quality Management Plan Guidance - 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