POST APPROVAL MONITORING AND EDUCATION PROGRAM

1
POST APPROVAL MONITORING AND EDUCATION
PROGRAM Jane Lehmbeck1, Sarah Blackman1, Karen
Davenport2, Karen Parks1 Office of the Vice
President for Research Graduate Studies,
University of Virginia, Charlottesville, VA1,
Clinical Trials Office, School of Medicine,
University of Virginia, Charlottesville, VA 2
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.
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
Virginias 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.
PROCESS
Compliance Monitor
Principal Investigator Study Team
Post Approval Monitoring Working Group
Post Approval Monitoring IRB Subcommittee
School of Medicine Educator
IRB Educators
Conducts Review
Global education, policy and process change
Education one-on-one at time of the review
Conducts tailored education and mentoring at the
monitors request, writes education report
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)
Programs Organizational Framework
PAM report generated F/U or tailored
education may be recommended
Reviews PAM report, PI response, education
report (if applicable) and minutes of PAM Working
Group May make additional recommendations (educat
ion and/or follow-up)
School of Medicine (SOM)
Office of the Vice President for Research
Graduate Studies (VPRGS)
Generate letter to PI and the PIs Department
Chair thanking them for participation and
notifying them of any additional IRB
recommendations
PAM Program
IRB for Health Sciences Research
IRB for Social Behavioral Research
Acts on any IRB issues related to report
Evidence of compliance and Understanding of good
clinical practice.
Education
Exceptional
Education
RESULTS
Few minor deviations noted. Education or
follow-up might be recommended.

• 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

For the 120 PIs, 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.
Satisfactory
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.
25
Investigators receiving a PAM review in 2006

60
58
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.
Marginal
n143 studies reviewed
n200 investigators
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 Ja
ne Lehmbeck, RN, BSN, CCRC Karen Parks, RN,
BSN, CCRC Post Approval Compliance Monitor Post
Approval Compliance Monitor Ph
434-924-8660 Ph 434-982-4311 Fax
434-924-1992 Fax [phone] Email
jff7c_at_virginia.edu Email knp_at_virginia.edu
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.
PAM
HRPP
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
Education
IRB