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
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’s Organizational Framework
Office of the Vice President for
Research & Graduate Studies
(VPRGS)
IRB for
Health
Sciences
Research
IRB for
Social &
Behavioral
Research
School of Medicine
(SOM)
Compliance
Monitor
Principal Investigator
& Study Team
School of Medicine
Educator
Post Approval Monitoring
Working Group
Post Approval Monitoring
IRB Subcommittee
IRB Educators
Conducts Review
Education
one-on-one
at time of the
review
Response required
to any findings
in the report
PAM report
generated
F/U or tailored
education
may be
recommended
Conducts
tailored
education and
mentoring at the
monitor’s
request, writes
education report
Global education,
policy and
process change
Reviews PAM and
ED reports and
PI response
(if applicable)
Reviews PAM report, PI
response, education report
(if applicable)
and minutes of PAM Working
Group
May make additional
recommendations
(education and/or follow-up)
May make
additional
recommendations
(education and/or
follow up)
Generate letter to
PI and the PI’s
Department Chair
thanking them for
participation and
notifying them of
any additional IRB
recommendations
PAM Program
Education
EVALUATION
PROCESS
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.
Acts on any IRB issues
related to report
Education
Exceptional
Evidence of compliance and
Understanding of good clinical practice.
Satisfactory
Few minor deviations noted.
Education or follow-up might be
recommended.
RESULTS
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
Investigators
receiving a PAM
review in 2006
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 IRBapproved 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.
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.
n=200
investigators
25
60
58
n=143 studies reviewed
Exceptional
Satisfactory
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.
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
Marginal
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.
PAM
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
HRPP
http://www.virginia.edu/vprgs/pam/index.html
Jane Lehmbeck, RN, BSN, CCRC
Post Approval Compliance Monitor
Ph: 434-924-8660
Fax: 434-924-1992
Email: jff7c@virginia.edu
Karen Parks, RN, BSN, CCRC
Post Approval Compliance Monitor
Ph: 434-982-4311
Fax: 434-924-1992
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
IRB
Education