Monitoring Audits/Quality Assurance (QIP)



Monitoring Audits/Quality Assurance (QIP)The IRB Quality Improvement Program (QIP), managed by the Research Compliance unit in the Office of Research Administration, aims to promote and ensure compliance with human subject research regulations and CWRU policy, and is required by the University’s Federalwide Assurance (FWA). The QIP reviewer is expected to assess, annually, at least five percent of open protocols or 15 open protocols, whichever is greater. Annually, a meeting is held by the Research Compliance Officer, HRPP Director, IRB Manager, and IO in which a quality improvement plan is developed and put into place, to be carried out by an individual or committee named by the IO to assesses compliance and measure targeted levels of quality, efficiency, and effectiveness of the HRPP (e.g., continuous investigator training; use of IRB-approved consent forms, turn-around time of exemption determinations, etc.). The plan will, at a minimum contain:The goals of the quality assessment/improvement plan with respect to measuring effectiveness, identifying opportunities for improvement and achieving and maintaining targeted levels of quality, efficiency, effectiveness and complianceAt least one objective to achieve or maintain compliance is definedAt least one measure of compliance is definedThe methods to assess compliance and make improvements are describedAt least one objective of quality, efficiency, or effectiveness is definedAt least one measure of quality, efficiency, or effectiveness is definedThe methods to assess quality, efficiency, or effectiveness and make improvements are describedResults of the plan are reviewed by the Research Compliance Officer, HRPP Director, IRB Manager and the IO to identify trends and to determine if systemic changes are required. If so, the Research Compliance Officer, HRPP Director and other relevant parties such as the IO, the IRB Chair, and the IRB Manager will collaborate in the development of a corrective action plan, its implementation, and evaluation of its effectiveness.The HRPP QI Auditor is responsible for tracking internal metrics that are informative in considering IRB and investigator efficiency. Metrics reports will be provided to the Research Compliance Officer, HRPP Director and IRB Chair twice per year.Within this oversight program, the required procedural and record-keeping audits will be accomplished at three different levels: quality assurance (record-keeping), compliance auditing (procedural) and FWA Institutional oversight. The IRB may also request for-cause audits at its discretion that will be conducted by the HRPP QI Auditor. Process. The Responsible Investigator (RI) will receive a written notification that a review is to occur within 14 calendar days from the date of the notification at the RIs facility/office. Investigators are asked to have a list of items available for review, which include the following:All executed informed consent documents;A count of the total number of subjects enrolled in the study to date;All data (e.g., files, subject records, questionnaires, surveys, etc.);Materials and/or documentation regarding subject feedback, including ?complaints, if applicable;Materials and/or documentation regarding subjects who prematurely discontinued their participation or who were withdrawn by the RI, if applicable;Reports of all instances of adverse events, if applicable;A list of all study team members; andAdditional requests for information may be made during the review. If at all possible the principal investigator and/or study staff may be present to address questions and provide any requested documents for immediate resolution during the audit.The reviewer will discuss the research performed to date with the investigator(s) and study team, which includes relevant records, such as IRB approved informed consent documents and collected data. The reviewer also conducts a review of the IRB actions to ensure that they acted in accordance with all applicable federal, state and local requirements related to the protection of human subjects.The QIP reviewer also reviews and checks for enrollment dates to ensure commencement of research did not begin before all approvals required by the University were granted. The QIP reviewer will submit a report to the IRB that includes findings from both reviews (investigator and IRB actions), and recommendations. The IRB reviews the report and determines if any additional IRB actions are necessary. A copy of the report is also submitted to the HRPP Director, who is responsible for addressing noncompliance by the IRB and reporting incidences to the Vice President of Research, who is listed as the Institutional Official on CWRU’s FWA. The Manager of the CWRU SBER IRB also receives a copy of the report so he/she can keep apprised of the findings. All information obtained from the review is kept confidential, and is shared only with necessary parties.The QIP Reviewer works with the Responsible Investigator, Co-Investigator(s) and the study team to address any problems found during the review and to resolve them to get the study back into compliance with the outlined CWRU SBER IRB approved protocol. Additionally, if the IRB asks for additional education or sanctions for the Responsible Investigator, Co-Investigator(s) and the study team members, the QIP Reviewer works with the Director of the IRB to establish these measures and helps to facilitate their completion. ................
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