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. Complete the QI Service Request Form 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
Informed Consent Process Monitoring (new)
Compliance/Quality Assurance Assistance
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ClinicalTrials.gov Registration |
ROUTINE QUALITY IMPROVEMENT ON-SITE REVIEW
On-site reviews are conducted by one or more QI program staff and depending on the nature and complexity of the study may require two to four hours to complete. During the review, the QI staff routinely reviews regulatory documentation, reconciles IRB documentation, and reviews subject files including consent forms. 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. Written reports are distributed to Principal Investigators (PI) for quality improvement and educational purposes. The final report does not become part of the study record and is not shared with the IRB. If serious findings are identified and corrective actions are not taken appropriately in accordance with institutional policy (e.g. major noncompliance), the QI Program is obligated to report those specific findings to the IRB. Contact Stanley Estime at 617-424-4136 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.
INFORMED CONSENT PROCESS MONITORING
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The QI Program can assist you in ensuring that your consent process is being conducted in accordance with federal regulations and institutional policies. Informed consent is a vital part of the research process that involves more than obtaining a signature on a form. The consent process is essential to ensuring that subjects are making an informed decision about whether or not to participate in the research. The QI team is available to observe your consent process for the purpose of identifying strengths as well as deficiencies or omissions that may inadvertently occur. By observing the consent process, the QI team will be able to provide timely and relevant feedback to the research team. If you would like to take advantage of this service, please contact Cindy Monahan at (617) 424-4139. |
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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 Stanley Estime at 617-424-4136 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.
During the Summer, the QI Staff holds informal question, answer and discussion sessions relating to clinical research at Partners. These small sessions are designed for new study staff with 12 months or less experience. QI Program staff will present a brief overview of the session topic and provide practical tips and handouts. The remainder of the hour will be spent discussing specific questions participants may have.
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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 |
COMPLIANCE/QUALITY ASSURANCE ASSISTANCE
In order to stay current with the regulatory/compliance issues as required in the protection of human subjects and responsible conduct of research, the QI Program offers consultation and education for Clinical Trials Registration. In order to schedule a consultation/training session, please contact Vicki Mirabello at 617-424-4140.