Effective Operation of Facility Research Program Review
Ensure the effective operation of the facility research program through oversight, communication, quality assurance, and improvement activities. Learn how the R&D Committee reviews subcommittee/committee minutes, facilitates communication, conducts QA/QI activities, and profiles quality programs at CSP Coordinating Center.
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Dial in (Main): (914) 614-3221 Dial in (Alt): (914) 339-0024 Attendee Access Code: 744-068-166 Slides in Handout Tab R&D Committee Workshop Series: R&DC Review of the Facility Research Program Moderated by: Soundia Duche, MA, MS Director, Education & Training ORPP&E July 15, 2020
Ensuring the Effective Operation of the Facility Research Program The R&D Committee is also responsible for ensuring the effective operation of the facility research program through oversight of all R&D Committee subcommittees and the facility s research portfolio. The R&D Committee accomplishes this by: Reviewing the operations of all research-related committees and subcommittees as an ongoing function, and Maintaining awareness of the state of the facility s research portfolio. The R&D Committee reviews all research related committees and subcommittees at least annually in part by: reviewing the minutes of each subcommittee that reviews VA research protocols; by close communication with the subcommittees; and through Quality Assurance and Quality Improvement Activities (VHA Directive 1200.01 paragraph 6f). 2
Introductions Nicholas McCray, Administrative Officer/Research & Development, Dayton VA Medical Center Paska Permana Ph.D., Human Research Protection Program Officer, Phoenix VA Healthcare System Amy Burns, JD, OTR/L, Associate Center Director for Quality Assurance, Cooperative Studies Program (CSP) Coordinating Center West Haven, CT Angela Foster, Program Manager/COR, VAIRRS and VAEDA Office of Research Protections, Policy, and Education 3
Overview Discuss R&D Committee review of subcommittee/committee meeting minutes Share examples of how the R&D Committee can facilitate close communication with its subcommittees/committees Discuss ways in which the R&D Committee can conduct quality assurance and quality improvement activities of its research related subcommittees and committees Profile the West Haven CSP Coordinating Center s Quality Program - highlighting the process used to identify risk-based quality indicators and measures Highlight how VAIRRS can be used as a data source for quality indicators 4
R&D Committee Review of Subcommittee & Committee Meeting Minutes 5
Reviewing Subcommittee and Committee Meeting Minutes Reviewing meeting minutes helps inform the R&D Committee of issues addressed or actions taken by subcommittees and committees that may require additional institutional action by the R&D Committee. Meeting minutes provide the R&D Committee with documentation of the operations of the R&D Committee subcommittees and committees. For external committees, reviewing meeting minutes can also assist in ensuring that the obligations detailed in the MOU or reliance agreement are being met. 6
Subcommittee Meeting Minutes R&D Committee subcommittees are required to provide the R&D Committee with copies of subcommittee minutes within 60 calendar days of the subcommittee finalization of the minutes. The minutes must include information on actions approved by the convened committee as well as a list of actions that were approved outside of committee, via an expedited (IRB) or designated member review (IACUC and SRS) process. A well-constructed quality assurance program at your site will help to ensure that the reporting of minutes is happening within the required 60 calendar days of finalization. 7
Is the R&D Committee Required to Approve Subcommittee Minutes? No. The R&D Committee is not required to approve subcommittee minutes, but it must document in its minutes its review of the subcommittee minutes within 60 days of the subcommittee s finalization of the minutes (VHA Directive 1200.01, Para 8.a.(3)). Examples of documentation include: The IRB s minutes were reviewed by the R&D Committee; there were no issues requiring discussion or action. The IRB s minutes were reviewed by the R&D Committee; the IRB reviewed 101 protocol deviations for Dr. 121 in its last meeting, but there is no indication that any actions were taken by the IRB. Additional information will be requested from the IRB regarding its review of the protocol deviations for Dr. 121 and any required reporting 8 VHA Directive 1200.01, Research and Development Committee: FAQ #1
What Date Should be Used to Determine when a Subcommittee Finalizes Minutes for Purposes of Ensuring that the R&D Committee Reviews Minutes within 60 Days? ORD policy does not define what date must be used. Subcommittee policies and procedures should define how minutes are finalized. The R&D Committee as part of its operations must maintain standard operating procedures or other written procedures for all recurring processes (VHA Directive 1200.01, Paragraph 6.e.). ORD recommends that the R&D Committee s written procedures include a statement(s) defining how the R&D Committee determines when subcommittee minutes are finalized for purposes of conducting the ORD required review of subcommittee minutes within 60 days. R&D Committee FAQ #12 provides sample language that can be included in the SOP. 9 VHA Directive 1200.01, Research and Development Committee: FAQ #12
External Committee Meeting Minutes The Memorandum of Understanding (MOU) or reliance agreement between the VA facility and the external committee must stipulate how actions approved by the committee will be communicated to the R&D Committee. MOUs must include a provision to allow the VA facility access to unredacted copies of meeting minutes related to VA business within 2 business days of written request to allow the R&D Committee to review deliberations on VA protocols. The MOU or reliance agreement should be reviewed on at least an annual basis to ensure the obligations detailed in the MOU or reliance agreement are being met. R&D Committee FAQ #19 includes information on what should be included in a MOU. 10 VHA Directive 1200.01, Research and Development Committee: FAQ #19
Facilitating Close Communication between the R&D Committee and its Research-Related Committees VA Research Program Examples 11
Cross-Pollination of Research Subcommittee and Committee Membership Rosters R&D Committee membership roster includes members from other committees/subcommittees. Chairs of research-related subcommittees are voting members of the R&D Committee. VA representatives on affiliate committees serve as members on other VA research-related subcommittees Members of research-related committees present significant issues to the R&D Committee during the review of committee/subcommittee meeting minutes. 12
Maintaining Awareness of the Research Portfolio Research Office serves as an intermediary between affiliate, R&D Committee, and investigator. Research office performs a preliminary review of all study submissions prior to submission to the affiliate research committee Chairs of various committees and/or research office staff meet on an ad hoc basis to discuss issues. 13
Maintaining Awareness of the Research Portfolio (continued) AO and Executive Director of the NPC brief the R&D Committee on the financial status of studies. Goal is to identify studies experiencing financial difficulty and the reasons why. 14
Quality Assurance/ Quality Improvement 15
R&D Committee Quality Assurance and Quality Improvement Activities The R&D Committee is required to conduct Quality Assurance (QA) and Quality Improvement (QI) activities on an annual basis as part of its oversight of the facility s research program ORD does not prescribe the specific number or types of activities that must be conducted The R&D Committee should select the quality indicators/quality measures most meaningful to its review Verifiable measures stated in either quantitative or qualitative terms that: Capture performance in terms of how something is being done relative to a standard or target Allow and encourage comparison Support the goals and objectives of the organization 16
How are Quality Indicators/Quality Measures Used? Quality metrics can be used to: Spot trends in performance (good and bad) Adjust processes per institutional goals and objectives Compare alternative processes Compare to both inside and outside benchmarks (best practices) Predict performance Support resource-related requests 17
Selecting Appropriate Quality Indicators/Quality Measures Effective quality metrics should: Be monitored and trackable Ability exists to monitor the metric on an on-going basis Be useful Metric should be used to inform decision making, e.g. improve a situation or validate an approach being used Simply collecting and reporting data isn t particularly helpful Associate Director of the West Haven CSP Coordinating Center s Quality Program will share the process they use to select appropriate quality metrics for their program. 18
CSP is a division of VA Office of Research and Development (ORD) CSP is responsible for the planning, conduct, and analysis of national multi-site studies The Cooperative Studies Program includes Five CSP Clinical Trials Coordinating Centers Four CSP Epidemiological Centers (CSPECs) CSP Clinical Research Pharmacy Coordinating Center (CSPCRPCC) Ten Network Of Dedicated Enrollment Sites (NODES) CSP, through the CSPCC assigned to a study, serves as the study sponsor VA Cooperative Studies Program (CSP) 19
The planned & systematic actions that are established to ensure that the activity is performed and the data is generated, documented, and reported in compliance with GCP (Good Clinical Practice) and applicable regulatory requirements. Quality Assurance/ Quality Control The methods used to assure and control the quality of the activity should be proportionate to the risks inherent in the activity and the importance of the information collected. 20
The Quality Management system should use a risk- based approach Critical Process & Data Identification Risk Identification Risk Evaluation Risk Control Risk Communication Risk Review Risk Reporting 21
The scope of the QMS is specifically defined as the services related to Coordinating Center support of national multicenter clinical research studies for the CSP CSP Quality Management System(QMS) West Haven Quality Objectives are the metrics that have been identified, based on an assessment of risk, to evaluate our center against the CSP Quality Policy. 22
We are committed to improving Veteran and National Healthcare by conducting cooperative research studies that are well-designed, produce high quality data, protect research participants and comply with applicable requirements and standards, while continuously improving the quality management system. CSP Quality Policy 23
WH-CSPCC Quality Objective Metric Goal as Goal as stated in stated in Quality Policy Quality Policy In any calendar year, submitted protocols will not reflect a third (or higher iteration) CSSEC submission. STUDY DESIGN In any calendar year, score of all CSSEC reviews are <=22 (if we have submissions) Actively recruiting studies are meeting 75% enrollment target within the previous calendar year. Note: 75% enrollment target goal is for after at least 1 year of enrollment 100% of local IRs reviewed/accepted/assigned by QMS within 30 calendar days after entered. Lost to follow-up for primary outcome does not exceed 25% of the estimate used in the study design. During first year of study recruitment: Less than 10% of participants had a randomization in error. During subsequent years of study recruitment: Less than 1% of participants had a randomization in error. DATA INTEGRITY / QUALITY 90% of queries, related to eligibility criteria elements and primary outcomes, were closed within 60 days, for randomized participants. 24
WH-CSPCC Quality Objective Metric Goal as Goal as stated in stated in Quality Policy Quality Policy <3% Informed Consent Forms for randomized participants with critical finding as described below within the previous calendar year. Note 1: A critical ICF finding for randomized participant consents meeting any one of the following: Missing signature(s), missing dates, incorrect version of the ICF, consent not signed prior to start of study procedures, or ICFs missing (site does not have it). HUMAN SUBJECTS PROTECTION Note 2: The calculation is as follows: # of consent forms with at least one critical finding / # of consent forms expected for the calendar year (randomized participants only). <3% of SAEs reported late/total # of SAEs reported within the previous calendar year, using date site became aware of SAE to allocate to calendar year. <3% of randomized participants with Eligibility Errors reported on protocol deviation forms within the previous calendar year. Note: These are the site-confirmed cases with eligibility errors. Maintain or exceed the number of previous year s citations from CSP funded primary publications published in past 5 years. IMPACT WH-CSPCC primary publications, published during the previous calendar year, were published in a journal with an impact factor of >=8 at the time of publication. 25
Number of studies either meeting recruitment targets, on time and on budget (or not meeting requirement targets) Research Program Quality Metrics (Examples) Number of primary publications per year Summary of protocol deviations/unanticipated problems Summary of complaints from participants involved in research Summary of lapses in approval for studies requiring continuing review Financial status of studies Number of studies in specific research areas Workload of committees, e.g. ratio of # of reviewers to # of projects overseen by a committee 26
Examples of R&D Committee QA/QI Activities Conducted by VA Research Programs Preparation and presentation of reports on the status of the research program to the R&D Committee and the Medical Center Director Annual reports on various committees/subcommittees Report on Research Program Resources and Budget List of Active CRADAs and MOUs List of Publications Summary report on WOC Appointments and Investigator CVs 27
Examples of R&D Committee QA/QI Activities Identified in FAQ Comparison of the # of VA studies approved by the research-related committee or subcommittee against the # of VA studies approved by the R&D Committee; Attendance of subcommittee or committee members; Documentation in the minutes of information specified by regulatory requirements, such as attendance and voting; Length of time required for the committee or subcommittee to review and approve modifications to previously approved research; Number of actions taken by the committee or subcommittee during a convened meeting, and the duration of the meeting; and Reviewing a subset of standard operating policies of its research- related committees and subcommittees to evaluate whether documentation reflects implementation of the reviewed standard operating policies. 28 VHA Directive 1200.01, Research and Development Committee: FAQ #2
VAIRRS as a Source of Data for Quality Metrics The VA Innovation and Research Review System (VAIRRS) platform consists of IRBNet: Data Collection and Insight Reports PowerBI Dashboards (under development): Committee specific metrics IRBNet Insight Reports PowerBI Dashboards VA Medical Center IRBNet 29
Insight Reports IRBNet has many standard reports (Insight Reports) available to system users which can be used to monitor measures such as review status of projects; number of projects assigned to reviewers; training reports for members and study teams; project status and expiration; and custom reports built on the available wizards and custom tags. 30
PowerBI Dashboards The data used to compile the Insight Reports will also be used to inform the PowerBI dashboard reports Dashboard metrics will be developed by field-based workgroups consisting of representatives from the local research office, Medical Center Directors, and VISN. Email VAIRRS@va.gov if you would like to participate in the dashboard metrics workgroup. 31
Contact Information for Panelists Nicholas McCray Administrative Officer/R&D Dayton VA Medical Center E-mail: Nicholas.McCray@va.gov Amy Burns, JD, OTR/L Associate Center Director for Quality Assurance Cooperative Studies Program (CSP) Coordinating Center Office of Research Protections, Policy, & Education West Haven, CT E-mail: Amy.Burns2@va.gov Paska Permana, PhD. Human Research Protection Program Officer Phoenix VA Healthcare System E-mail: Paska.Permana@va.gov Angela Foster Program Manager, VAIRRS and VAEDA E-mail: Angela.Foster@va.gov 33
Questions 34
Availability of Recording A recording of this session and the associated handouts will be available on ORPP&E s Education and Training website approximately one week post-webinar An archive of all ORPP&E webinars can be found here: https://www.research.va.gov/programs/orppe/education /webinars/archives.cfm 35
Research and Development Committee Workshop Series Proposed Training Training Type Tentative Date Differentiating roles of the R&D Committee and the IRB Traditional Webinar 11/7/2019 R&D Committee Responsibility: Review and Approval of Research Workshop 12/11/2019 R&D Committee Operations: Convened Meeting vs. Designated Member Review (DMR) Workshop 12/19/2019 R&D Committee Responsibility: Part 1- Review and Approval of Exempt Research Workshop 2/4/2020 and 2/19/2020 R&D Committee Responsibility: Non-Compliance Review and Reporting Workshop 3/4/2020 Review and Approval of Exempt Research: Part 2 - Capstone Case Workshop 4/9/2020 R&D Committee Responsibility: Review and Approval of Amendments and Continuing Reviews Workshop 6/3/2020 R&D Committee Responsibility: QI/QA Activities Workshop 7/15/2020 R&D Committee Responsibility: Review and Approval of Non- Veterans Workshop TBD 36
Important Links Revised Common Rule (published January 19, 2017) Pages 7259 to 7274 contain the Text of the Final Rule VHA Directive 1200.05 VHA Directive 1200.01 ORD Policies and Guidance Documents ORPP&E Cyberseminars ORPP&E FAQs ORPP&E s Single IRB webpage VA Innovation and Research Review System (VAIRRS) 37
