1. POST APPROVAL MONITORING AND EDUCATION PROGRAM Jane Lehmbeck 1, Sarah Blackman 1, Karen Davenport 2, Karen Parks 1 Office of the Vice President for Research & Graduate Studies, University of Virginia, Charlottesville, VA 1, Clinical Trials Office, School of Medicine, University of Virginia, Charlottesville, VA 2 Do researchers follow good clinical practice guidelines when performing their research? The Post Approval Monitoring and Education (PAM and ED) Program was created at the University of Virginia to help answer this question. The PAM and ED Program arose out of the University of Virginia’s commitment to ensuring the safety of all human subjects involved in research at UVA and to comply with federal regulations. The PAM and ED Program was modeled after three successful programs at other institutions, and also a successful post-approval monitoring program for research involving animals at the University of Virginia. Program Objectives Balance the institution's role of promoting compliance and subject safety with a commitment to providing education, service and respect for research investigators Provide internal compliance oversight of the performance of human subject research Ensure the rights and well-being of research subjects Ensure the quality and integrity of the research Identify and address educational and research support needs Ensure compliance with federal, state, local and institutional regulations and guidelines Identify areas of strength in addition to needs for improvements in research policies and practice Program Overview Random post approval monitoring reviews are conducted on all active IRB- approved full-board or expedited clinical research studies. During a review, the monitor meets with the study team and then inspects study records to assess adherence to the approved protocol and Good Clinical Practice. Following the review, the compliance monitor prepares and shares a report with the study team offering a summary of the review and recommendations for improvement. Most cases of noncompliance result from a simple lack of information or misunderstanding of regulations. These cases can be corrected with tailored follow-up education, guidance and support. Information learned from the reviews is also used to develop wider educational offerings, provide feedback to the IRB and improve institutional research policies and procedures. EVALUATION Program evaluation: the Program is monitored internally by two groups: the PAM Working Group and the IRB PAM Subcommittee. Each group meets once per month. The membership of the PAM Working Group consists of the two post-approval monitors, the UVA School of Medicine Clinical Trials Office Educator and Director, the IRB Educators, IRB Director and Associate Director, and the Associate Vice President for Research. This group reads and evaluates each PAM report for consistency, as well as appropriateness of recommendations made by the monitor and may make additional educational requests if appropriate. The PAM Working Group also reviews overall educational needs among UVA researchers, evaluates trends and recommends PAM and ED and/or IRB policy and procedure changes. The IRB PAM Subcommittee reviews PAM reports and PAM Working Group meeting minutes. Investigator evaluation: the monitor assigns one of three review categories to every PAM report that is generated. The first review category is “exceptional” which means the researcher has demonstrated compliance with federal regulations and good clinical practice guidelines for their research. The second review category is “satisfactory” which can mean at least one minor deviation was noted during the PAM review. Follow-up education and a second review of the same investigator may be recommended. The third category is “marginal” with at least one major (or several minor) deviations noted. Education is usually required, and re-review will occur three to six months following the initial review. These three review categories are used for internal purposes only and are not shared with the research team. PAM report generated F/U or tailored education may be recommended Response required to any findings in the report Reviews PAM and ED reports and PI response (if applicable) May make additional recommendations (education and/or follow up) Compliance Monitor Principal Investigator & Study Team Post Approval Monitoring Working Group Post Approval Monitoring IRB Subcommittee Conducts Review School of Medicine Educator IRB Educators Education one-on-one at time of the review Conducts tailored education and mentoring at the monitor’s request, writes education report Reviews PAM report, PI response, education report (if applicable) and minutes of PAM Working Group May make additional recommendations (education and/or follow-up) Acts on any IRB issues related to report Generate letter to PI and the PI’s Department Chair thanking them for participation and notifying them of any additional IRB recommendations Global education, policy and process change Human Research Protection Programs (HRPP): Implementation of Post Approval Monitoring and Education at Your Institution To implement this program, institutions must staff the program with experienced and respected professionals, establish and adhere to Standard Operating Procedures, and ensure cooperation and financial support from the institution with emphasis on the service and educational aspects. We believe the most important resource required for an institution interested in adapting a Post Approval Monitoring and Education program are dedicated full-time monitors who are neither researchers nor administrators working for the IRB, and the ability to provide customized education. The UVa Post Approval Monitors and Educators are happy to answer questions or offer advice for implementing a similar program at your institution. Contact information and Standard Operating Procedures can be found at http://www.virginia.edu/vprgs/pam/index.html Jane Lehmbeck, RN, BSN, CCRCKaren Parks, RN, BSN, CCRCPost Approval Compliance Monitor Ph: 434-924-8660Ph: 434-982-4311 Fax: 434-924-1992Fax: 434-924-1992 Email: jff7c@virginia.edu Email: knp@virginia.edu Authors wish to thank the following people for their contribution to the development of the PAM and Ed Program at UVa: Dr. David Hudson, Dr. Karen Schwenzer, Susie Hoffman and Lori Elder Office of the Vice President for Research & Graduate Studies (VPRGS) School of Medicine (SOM) PAM Program IRB for Health Sciences Research Education Program’s Organizational Framework IRB for Social & Behavioral Research Education PROCESS RESULTS In 2006, there were 200 principal investigators of clinical research at the University of Virginia that had one or more studies eligible for a PAM review. Of these, reviews were conducted for 120 (60%) investigators. Exceptional Satisfactory Marginal Evidence of compliance and Understanding of good clinical practice. Few minor deviations noted. Education or follow-up might be recommended. At least one major or several minor deviations noted. Education likely to be required. A second review of the same protocol will occur in 3-6 months. Investigators receiving a PAM review in 2006 n=200 investigators For the 120 PI’s, a total of 143 studies were reviewed in the PAM Program last year at the University of Virginia. Of these, 60 (42%) were rated exceptional, 58 (41%) satisfactory and 25 (17%) marginal. n=143 studies reviewed 60 25 58 PAM IRB Education HRPP