ࡱ> 9 05bjbjV@V@ F4*h4*h,O :::::NNN8DN2&^^\< y1{1{1{1{1{1{1$D461:|"1::1."""^::y1"y1""r,-@xJv-e11<2!-77--J7: .\"11F!27 X : FAQ: HSDs Post-Approval Verification and Education (PAVE) program Purpose of the program: The purpose of the University of SAʴý (UW) Human Subjects Division (HSD) Post-Approval Verification and Education Program (PAVE) is to use a collegial approach to confirm by observation that UW human subjects research is conducted in compliance with relevant federal regulations, state laws, UW institutional polices and Institutional Review Board (IRB)-approved procedures. The PAVE program provides targeted education and tools to the researcher to address identified gaps. It also contributes to the Universitys Human Research Protection Program by identifying (1) needs for systemic education and clarification, and (2) areas of strength and best practice. All IRB-reviewed human subjects research conducted at the UW is eligible for monitoring by the PAVE program. Frequently asked questions Under what regulatory or institutional authority was this program implemented? Federal regulations at 45 CFR 46.109(g) and 21 CFR.56.109(f) say: An IRBshall have the authority to observe or have a third party observe, the consent process and the research. Institutional authority, as described in the Vice Provost for Research Delegation Memo (December 30, 2010), gives the HSD Director the responsibility to create this program and monitor its progress in order to meet the IRBs regulatory obligations. As a lead researcher am I required to comply if selected for a PAVE evaluation? Yes. However, the PAVE monitor will attempt to schedule the review for a date and time that is mutually agreeable with the researcher. How does the PAVE visit differ from site monitor audits? The PAVE program may overlap in some areas with other monitoring efforts but will also include areas not typically addressed elsewhere such as: Adherence to the IRB-approved study protocol Data security and confidentiality Data and Safety Monitoring Plan (DSMP) adherence Research collaborations with non-UW partners How much time will the PAVE visit require? For in person monitoring, the visit typically begins at 9am and usually lasts 3-6 hours. It consists of a review of the study records followed by an interview with the Lead Researcher. This interview should not take more than 30 minutes. An optional 30-minute exit interview to review preliminary findings with the study team is also available and can be done concurrently with the Lead Researcher interview if scheduled after the records review is complete. For remote monitoring, the visit may be conducted in a single day or occur over several days during a given week. For example, the 30-minute interview with the Lead Researcher could be conducted one day with subject records reviewed on another. For the day(s) subject records will be reviewed, someone from the study team should be available by phone or video conferencing for questions or requests for additional information. Remote record reviews will occur Monday Friday, 9am-5pm Pacific Time, (unless alternate arrangements are made) and in total will take 3-6 hours to complete. What aspects of a study will the PAVE program review? The following aspects of a research study, if applicable, will be reviewed: Subject recruitment Subject eligibility including documentation of inclusion and exclusion criteria Consent process and documentation Confirmation that study procedures are conducted per IRB approval Involvement of non-UW collaborators Confidentiality and data security Data and safety monitoring procedures Drug or device administration and accountability Compliance with applicable federal regulations, state laws and institutional policies regarding human subjects research It is anticipated that between 10-20% of the studys research records will be reviewed at a single visit. If problems are identified, additional records may be reviewed. If fewer than 10 subjects have been enrolled, all subject records may be reviewed. PAVE monitors will review research records for the selected subjects including (but not limited to): Consent documents Screening forms Source documentation of eligibility Data collection forms (e.g., diaries, questionnaires, case report forms, etc.) In addition to the review of study records, the PAVE monitor will also conduct an interview with the Lead Researcher and study staff identified by the Lead Researcher. The interview will involve questions regarding how all aspects of the study are being conducted. What will I need to provide prior to the PAVE visit? The PAVE monitor will send an email before the visit requesting additional information about the study to be provided 4 weeks in advance of the visit. This will include: A list of all subjects with date of enrollment A copy of all blank data collection forms currently in use Approximately 3-business days prior to the visit you will need to provide or have available: The location of the study site where the visit will occur (in person visit only) The location of and instructions for accessing electronic study records for selected subjects (remote monitoring only) A signed attestation that applicable  HYPERLINK "/research/policies/zipline-guidance-data-security-protections-2/" data security protections are being met Copies of written processes or contracts required to meet the applicable data security requirements Does the Lead Researcher need to be present for all or part of the evaluation or can this be delegated to another member of the study staff? The Lead Researcher must be present at the interview portion of the visit. All study team members are invited to participate in the interview. However, it is the responsibility of the Lead Researcher to determine which members of the team will be present. The presence of the Lead Researcher is not required for the study document review as long as a member of the research team is available in person, by phone, video conferencing, or email for questions. Where will the evaluations take place? PAVE visits will take place either at the local site of the researchers choice or remotely (e.g., video conferencing, electronic access to study records). The PAVE monitor will confirm when scheduling whether it will be conducted in person or remotely. If in person, the study team will be asked to reserve a space for the visit, such as a conference room or empty office. If conducted remotely, the PAVE monitor will work with the study team to identify where and how records will be accessed electronically and schedule time to conduct the interview portions by phone/video conferencing. What are the primary differences between an in-person versus a remote visit? In-person visit: Monitoring procedures are conducted on the day of the visit Study materials are provided to the PAVE monitors on the day of the visit A study team member needs to be available to answer questions (by phone or email) throughout the day of the review Study materials can be reviewed in hardcopy or electronically Interview with the Lead Researcher occurs on the day of the visit Optional Exit Interview to discuss preliminary findings occurs the day of the visit For remote visits: Monitoring procedures take place remotely over the course of the visit week. There is no need to provide a physical space for review. Location of and instructions for accessing electronic study records for selected subjects are provided to the PAVE monitors approximately 3 days prior to the start of the visit Study materials are reviewed electronically Interview with the Lead Researcher can be scheduled any time during the review week (e.g., phone, Zoom) Optional Exit Interview to discuss preliminary findings may be scheduled to occur after records review is complete When will I receive information about any findings of the PAVE Evaluation? The PAVE monitor will discuss their findings with the study team during the exit interview portion of the visit. A draft PAVE Evaluation Report with a summary of observations will be sent to the Lead Researcher, and those members of the research team the Lead Researcher designates, within 3 4 weeks after the PAVE visit. Will the Lead Researcher and/or research staff members have a chance to review and comment on the PAVE Evaluation before it is finalized? Yes, the Lead Researcher and any designated staff will receive a copy of the draft evaluation with a request for their comments and suggestions. How will the final PAVE Evaluation Report be reviewed? The report will be reviewed by the PAVE Monitor as a Report of New Information (RNI), to determine if any observations meet the regulatory criteria for required reporting to University of SAʴý (UW) officials, regulatory officials, funding agencies, and sponsors. PAVE Evaluation Reports may be reviewed by the convened IRB in the following circumstances: The evaluation has been requested by the IRB The report describes  HYPERLINK "/research/glossary/serious-non-compliance/" serious noncompliance,  HYPERLINK "/research/glossary/continuing-non-compliance/" continuing noncompliance, an or  HYPERLINK "/research/glossary/unanticipated-problem/" unanticipated problem At the discretion of HSD Who will receive copies of the final PAVE Evaluation Report? The final report is always distributed to: The PAVE Monitor The IRB with oversight of the study The lead researcher of the study Additional individuals, groups and compliance offices may be notified of the observations described in the report depending upon the outcome of the review by HSD and the IRB. I am a student but also the Lead Researcher for my study: Does my faculty advisor need to be present at the PAVE evaluation? It is preferred that the faculty advisor be present during the interview, but exceptions can be made with prior approval. How often can I expect the PAVE program to monitor my study? In most cases, a study will be monitored by the PAVE program only once. After reviewing the PAVE Evaluation Report, if the IRB determines additional aspects of the study need to be reviewed, a second visit may be scheduled. If there are problems identified during the evaluation, what will I be required to do? After the IRB reviews the final PAVE Evaluation Report, the PAVE monitor will inform the researcher if there are any actions required by the IRB. When will I hear back about the IRBs review of the PAVE Evaluation Report? The time it takes to hear back about the IRBs review will depend on several factors, including the significance of the observations, the complexity of the proposed corrective action plan, and IRB workload. Will there be a way for me and/or my research staff to provide feedback about the PAVE program and our experience with it? Yes, a survey will be sent to the Lead Researcher after the final PAVE Evaluation Report has been submitted in Zipline as a Report of New Information. If the PAVE Evaluation Report identifies non-serious problems does the monitor have the authority to require specific corrective or preventive actions? The PAVE monitor may suggest some potential corrective actions to the researcher but only the IRB has the authority to require additional actions after its review of the PAVE Evaluation Report. Who do I contact if I have additional questions? Contact the HSD PAVE program at  HYPERLINK "mailto:hsdpave@uw.edu" hsdpave@uw.edu.      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