Conduct Routine Quality Assurance and Quality Improvement Onsite Reviews.
As
of January 2004, in an effort to improve the overall quality of human research
conducted at Partners Institutions; the QI Program has conducted more than 400 routine
internal QA/QI on-site reviews. These comprehensive on-site reviews are
conducted through:
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QA/QI projects where investigators are randomly selected to participate on a voluntary basis. |
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Not-for-cause mandatory internal on-site reviews by the QI Program. |
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Requests from investigators or study staff to ensure study site compliance. |
The
QA/QI checklist is the
primary tool used in conducting routine on-site reviews. The checklist was
developed by the QI Program to incorporate all the necessary elements required by Federal
regulations and Good Clinical Practice (GCP) guidelines as well as Partners
Institutional requirements. In most instances, a written report is
generated based on on-site observations. Reports
are distributed to the investigators for quality improvement purposes only. This confidential peer review
information does not become part of the study site file, and will not be
shared with the IRB.
Assist
Investigators and Study Staff in Conducting Self-Assessments
Over
the past two years, more than 300 Principal Investigators (PI) have received a self-assessment
checklist to review one of their studies. The use of this comprehensive checklist provides an
opportunity for the PI and study staff to identify areas that require corrective
action. Applicable references such as the FDA regulations, the Good Clinical Practice (GCP) guidelines,
and Partners
Institutional requirements are included in the checklist. 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 investigators/study staff may also request an on-site
review from the QI Program to assist them in the completion of the checklist.
Provide An Annotated Study Binder to Facilitate Proper Documentation
To assist investigators with study documentation, the QI Program provides study sites with an annotated study binder. This binder contains guidance and prompts for ensuring proper record keeping, and study maintenance of all study-specific information and regulatory documentation that must be maintained according to Federal regulations, ICH Good Clinical Practice (GCP) guidelines and Institutional policy. Documents may vary for each site so templates and accompanying information (in the form of QI tips) are also provided. To set up an appointment to meet with a member of QI staff, and obtain a study binder, please call 617-424-4144, or e-mail HumanResearchQI@partners.org.
On-site Review and Consultation for Study Start-up
The QI Program can assist investigators with "study start-up". Using the IRB-approved protocol, and working with the research team, the QI staff develops study-specific data collection forms and CRFs to allow for the capture, access, and management of study data.
Monitoring of On-going Studies
Proper monitoring is necessary to assure adequate protection of the rights and welfare of human subjects, and the quality and integrity of study data. The QI Program assists investigators with adherence to regulatory requirements, ICH Good Clinical Practice (GCP) guidelines, and Institutional policies by monitoring on-going studies. The QI staff conducts on-site monitoring at regularly scheduled intervals to assure:
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Protocol adherence |
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Accurate, complete, and current record keeping |
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Accurate, complete and timely reporting to the IRB |
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Adequate subject records and source documents |
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Appropriate informed consent process |
All QI Program activities can be customized to meet your study's specific needs. Contact us for a consultation to discuss how this monitoring service can best work for you and you research team.
Conduct Directed (for-cause) Audits
Directed
for-cause audits are conducted in response to:
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Requests from the Partners Institutional Review Board (IRB) |
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Subject complaints |
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Sponsor complaints |
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Requests from institutional officials |
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Requests/concerns from government agencies (e.g., FDA, NIH, OHRP) |
As
of June 2003, the QI Program has conducted about 40 for-cause audits. The
majority of such audits are requested by the IRB Continuing Review
Committee. A written report is usually generated at the completion of the
audit. This report is based on observations made on-site. The
investigator is given an opportunity to discuss the preliminary audit report
with QI staff and provide clarification where necessary. Investigator's
comments are incorporated into the final report as appropriate. All
reports generated as a result of a directed/for cause audit are distributed to
the investigator, the Department Chief, and the IRB. When applicable,
reports will also be distributed to an institutional official, or the regulatory
agency that requested the investigation.
Prepare
Study Sites for External Audits
The
QI Program staff has the expertise and experience to assist study sites as they
prepare for upcoming audits by FDA, NIH, or other external agencies.
The Principal Investigator (PI) or another individual may request an onsite
review of the study files, or a mock audit by the QI staff, as soon as they
receive an audit notification. Such internal pre-audit reviews help the
PI/study site to effectively identify deficiencies, and affords the PI an
opportunity to take corrective actions or make a
corrective action plan before an external audit commences. This
preparation has received favorable comments from both investigators and
outside regulatory/compliance agencies.
Assist Investigators with IRB Continuing Review Submission
As part of our efforts
to facilitate the IRB review and approval process, the QI Program offers
investigators assistance with their IRB continuing review submission. After
initial review and approval by the IRB, the investigator is responsible for
proper study conduct and appropriate communication of study activity with the
IRB. To avoid unnecessary delay due to an incomplete submission, investigators
are encouraged to seek assistance from the QI staff to smooth the IRB review and
approval process. The QI Program staff will also use this opportunity to provide
the investigators and study staff with practical tools and other relevant
recommendations for ensuring study site compliance and improving performance.
Provide Consultation and Continuing
Education for Investigators and Study Staff
The
QI Program recognizes the importance of continuing education for research staff,
and therefore offers various programs designed for the convenience and
knowledge level of all research staff.
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QI Round Table Discussion - Discussions are offered at study sites for investigators and study staff. These informal sessions are planned at a time and place convenient to the site. The QI Staff will answer questions, clarify policies, and discuss topics specific to the study. Each session provides a review of regulatory compliance issues and makes recommendations for improving study site performance. |
If you are interested in scheduling a Round Table Discussion, please contact the QI Staff, or call 617-424-4144.
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QI Presentations - The QI Program co-sponsors seminars and orientation lectures with BWH CCI and MGH CRP. Topics include Federal regulations and GCP guidelines, Partners clinical research guidelines, record keeping and documentation, and HIPAA Privacy Rule in research. |
Provide Internship Opportunities for Graduate Students in
Clinical Research Related Programs
Graduate 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.