In 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.
Routine Quality Improvement On-Site Review
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QI Program Initiated Review |
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Study Site Initiated Review |
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Preparation For External Audit |
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Assistance to Sponsor-Investigator |
Directed/For-Cause On-Site Review
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Onsite Monitoring |
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Online Monitoring |
ROUTINE QUALITY IMPROVEMENT ON-SITE REVIEW
On-site 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. 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 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.
Routine on-site reviews are initiated as a result of the following:
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The 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. The QI Program has conducted more than 700 routine on-site reviews since January 2000.
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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 issue.
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Preparation for External Audit |
The 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 regulatory/compliance agencies.
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Assistance to Sponsor-Investigator |
If you are the holder of an IND (a.k.a. Sponsor-Investigator), you assume the responsibilities of both an investigator AND a sponsor. The QI Program can assist you in ensuring compliance with FDA regulations governing sponsor-investigators. The QI Program has developed a checklist as well as other relevant tools that will help you to meet the FDA requirements and be ready for an unexpected audit. The best way for the QI Program to help you is through an on-site review, during which the QI staff will guide you through your responsibilities including setting up essential documents, data collection, record keeping, monitoring activities and FDA reporting requirements. This type of on-site review usually takes between 2 - 4 hours.
If you would like to schedule a review/consultation, or are interested in learning more about our service, please contact Sarah White at 617-424-4137.
DIRECTED / FOR-CAUSE ON-SITE REVIEW
Between January 2002 and April 2007, the QI Program conducted 107 for-cause reviews. Eighty-three of the 107 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).
Directed on-site reviews are conducted by one or more QI program staff and take approximately 2-4 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.
More than 300 investigators have utilized the QI Program's 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. Once the self-assessment checklist is completed, the study site may request an on-site review from the QI Program to provide on-site follow-up to the completed checklist. 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:
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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, FDA |
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Adequate subject records and source documents |
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Appropriate informed consent process |
The 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.
The QI Program offers the following two forms of monitoring:
| On-site Monitoring |
After initial 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.
After each monitoring visit, the QI staff will provide the PI/study site with written documentation of observations, queries and required corrective actions.
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On-line monitoring facilitates the monitoring process and minimize the amount of time required to conduct on-site monitoring. The on-line monitoring system allows remote oversight of study activity in conjunction with periodic on-site review. The on-line monitoring system's "Form-Builder" application can assist you with the development of data collection sheets/CRFs. For more information about on-line monitoring, please contact Stanley Estime at 617-424-4136. |
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Small Group QI In-service |
The 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.
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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 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.
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The QI Staff 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 here.
Starting Fall 2005, the QI Program offers quarterly lectures, known as "QI Program Roundtable Discussion Series" to the BWH and MGH research communities. During the Summer, the discussion topics are geared towards new research coordinator's and nurses. To register for upcoming Summer Series lectures, please click here .
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In 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.The half-day course covers the following topics:
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Overview of BWH/MGH clinical research system |
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Federal regulations and guidelines |
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Partners clinical research policies and guidelines |
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Record keeping and documentation |
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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. If you have any questions regarding intership opportunities, please contact Stanley Estime, Sr. QI/QA Specialist for more information.