an effort to ensure optimal conduct of human research within the framework
of institutional policy and regulatory requirements, and to provide
educational resources to Partners investigators and their research teams,
the QI Program provides a variety of valuable services to the Partners
research community. All QI
Program services can be customized to meet the specific needs of an
investigator and study site. Contact
us to schedule a service that can benefit you and your research team.
Quality Improvement On-Site Review
Program Initiated Review
Site Initiated Review
For External Audit
IRB Submission Assistance Annotated Study Binder Consultation and Education
QUALITY IMPROVEMENT ON-SITE REVIEW
reviews are conducted by one or more QI program staff and can take from
two to four hours to complete based on the nature and complexity of the
study. Using a checklist,
the QI staff reviews regulatory documentation, reconciles IRB
documentation, and reviews subject files including consent forms.
Additional aspects of study conduct may also be reviewed.
All on-site reviews include an exit interview and written report,
both of which address all on-site observations, corrective actions and
quality improvement recommendations.
All findings are confidential peer-review information, which does
not become part of the study record, and is not shared with the IRB.
Written reports are distributed to Principal Investigators (PI) for
quality improvement and educational purposes. Contact Sarah White at 617-424-4137 if you are interested in any of the following on-site reviews.
on-site reviews are initiated as a result of the following:
QI Program periodically invites PIs to participate in on-site reviews of
their study records by the QI staff. The PI selection is random
and the selected PI has the option to defer or decline participation.
QI Program has conducted more
than 500 routine on-site reviews since January 2000.
Site Initiated Review
Comprehensive on-site reviews are also conducted at the
request of study sites. A
Principal Investigator or a member of the research team can request an
on-site review to ensure overall compliance or to address a specific
for External Audit
QI Program staff has the knowledge, expertise and experience to assist
study sites as they prepare for upcoming audits by the FDA, NIH,
sponsors or other external agencies. Upon receipt of an audit
notification, study staff may request an on-site review of all study
files. This internal
pre-audit provides the PI/study site the opportunity to identify
deficiencies, and take necessary corrective actions before an external
audit commences. This particular QI service has received
favorable comments from both investigators and outside
/ FOR-CAUSE ON-SITE REVIEW
2002 and September 2004, the QI Program conducted 35 for-cause reviews.
Twenty-six of the 35 reviews were conducted at the request of Partners
Continuing Review Committee(s) in order to facilitate the continuing
review and approval process, and to ensure good record keeping and a proper
informed consent process. These
directed reviews may be referred to as audits and can also be conducted in
response to subject or sponsor complaints, requests from Partners
institutional officials, or concerns from government agencies (e.g.,
FDA, NIH, OHRP).
on-site reviews are conducted by one or more QI program staff and take
hours to complete. All
directed/for-cause reviews include an exit interview and written report.
Information contained in the report is based on observations made
on-site as well as discussions with the investigator and research team.
The investigator is given an opportunity to discuss the preliminary
report with the QI staff and provide clarification where necessary. All reports are distributed to the PI,
and unlike routine on-site reviews,
also to the IRB. In addition,
the report may be shared with applicable parties such as Department
Chiefs, an institutional official, or a regulatory agency.
than 300 investigators have utilized the QI Programís self-assessment
checklist to review one of their studies.
This comprehensive checklist is used to identify areas that require
corrective action and to familiarize a study site with regulations and the
proper conduct of research. Direct links to applicable references
such as Federal
Clinical Practice (GCP) guidelines,
included in the checklist. Once the self-assessment checklist is
completed, the study site may request a written report from the QI
Program. This report provides comments and recommendations based on
information provided on the checklist. The study site may also
request an on-site review from the QI Program to assist them with the
completion of the checklist or to provide on-site follow-up to the written
report. If you have any questions regarding the self-assessment checklist, please contact Sarah White at 617-424-4137.
Proper study monitoring is necessary to assure adequate
protection of the rights and welfare of human subjects and the quality and
integrity of study data. In
addition, proper monitoring ensures:
Accurate, complete, and current record keeping
complete and timely reporting to the IRB, FDA
subject records and source documents
informed consent process
QI program offers study-specific monitoring services.
Contact Stanley Estime to schedule a consultation to discuss how our monitoring services
can best work for you and your research team.
QI Program offers the following two forms of monitoring:
consultation, the QI staff will conduct on-site monitoring at regularly
scheduled intervals throughout the duration of the study. Continuous
on-site monitoring activity includes, overseeing the progress of the
study, to ensure that it is conducted, recorded and reported in
accordance with the protocol. Monitoring activity includes but is not
limited to, review of consent forms, data collection, source
documentation and regulatory documents.
monitoring visit, the QI staff will provide the PI/study site with
written documentation of observations, queries and required corrective
program is currently developing an on-line monitoring system. This
exciting new service will be available in Spring 2006. On-line
monitoring will facilitate the monitoring process and minimize the
amount of time required to conduct on site monitoring. This on-line
system will allow remote oversight of study activity in conjunction
with periodic on-site review. For more information about on-line
monitoring, please contact Stanley Estime at 617-424-4136.
facilitate the IRB review and approval process, the QI Program offers
investigators assistance with their IRB submissions. This service
includes answering questions regarding submission requirements, navigating
forms, and identifying questions/concerns that reviewers may potentially
raise. The QI Program staff
will also use this opportunity to provide investigators and study staff
with practical tools and other relevant recommendations for improving
study site compliance and performance. Investigators are encouraged to contact Lucy Feild at 617-424-4139 for
assistance with initial and continuing review submissions.
assist investigators with study documentation, the QI Program provides study sites with an annotated study binder (now also available online via the QI Program website).
Binders can be customized for each specific study.
Study log templates, compliance checklists, and regulatory
requirements (in the form of
QI tips) are provided within the binder. To obtain a study binder,
please set up an appointment with Lucy Feild at 617-424-4139.
Small Group QI In-service
QI program offers small group in-services for investigators and study
staff. This service
provides the study site with an opportunity to ask questions, discuss
policies and address site-specific issues relating to the conduct of
research. These informal
sessions are planned at a time and place convenient to the attendees.
To set up an in-service please contact Sarah White at 617-424-4137.
Consultation for study start-up
QI Program can assist investigators with "study start-up."
Using the IRB-approved protocol, and working with the research team, the
QI staff can develop study-specific data collection forms to allow for
the capture, access, and management of study data.
In addition, QI staff members can offer assistance with study
coordination, including proper record keeping and study documentation. Please contact Sarah White at 617-424-4137 in order to set up a consultation.
QI Staff and the Program Director, Dr. Delia Wolf, have been invited to
present at local, regional, and national levels. Topics have included
research compliance, common violations in conducting clinical research,
monitoring/auditing research studies, and investigator
initiated/sponsored research. To access previous presentations click
Starting September 2004, the QI Program offers quarterly
lectures, known as "Quality Improvement Compliance And Knowledge ~
Bringing Information To Everyone (Quick Bite)"
to the BWH and MGH research communities.
Clinical Research Staff Orientation
collaboration with MGH
Clinical Research Program (CRP) and BWH
Center for Clinical Investigation (CCI), the QI Program gives
orientation lectures for new clinical research staff.
course covers the following topics:
of BWH/MGH clinical research system
regulations and guidelines
clinical research policies and guidelines
keeping and documentation
students in clinical research related programs benefit from the hands-on
experience provided by the QI Program as part of an Internship/Mentored
Field Experience. Under direct supervision by the Program
Director, students work closely with the QI staff, and are given the
opportunity to be involved in the full spectrum of human research
protection activities. If you have any questions regarding intership opportunities, please contact Delia Wolf, QI Program Director for more information.