BACKGROUND & AUTHORITY
ACTIVITIES/ SERVICES
NON-COMPLIANCE CITATIONS
INVESTIGATOR INFORMATION
COMMON FINDINGS
TOOLS
PUBLICATIONS/ PRESENTATIONS
STAFF CONTACTS
LINKS
HOME

ACTIVITIES AND SERVICES

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

 QI Program Initiated Review 

 Study Site Initiated Review 

 Preparation For External Audit

 

 Directed/For-Cause On-Site Review

 

 Investigator Self-Assessment

 

 Study Monitoring

 Onsite Monitoring 

 Online Monitoring

 

IRB Submission Assistance   Annotated Study Binder  Consultation and Education

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.  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.

Routine on-site reviews are initiated as a result of the following:

QI Program Initiated Review

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 500 routine on-site reviews since January 2000.

Study 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 issue.   

 

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.

Top of page

DIRECTED / FOR-CAUSE ON-SITE REVIEW

Between January 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). Directed on-site reviews are conducted by one or more QI program staff and take approximately four 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.

Top of page 

 

INVESTIGATOR SELF-ASSESSMENT

More 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 regulations, Good Clinical Practice (GCP) guidelines, and institutional guidelines are 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.

Top of page 

STUDY MONITORING

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:

Protocol adherence 

Accurate, complete, and current record keeping 

Accurate, complete and timely reporting to the IRB, FDA 

Adequate subject records and source documents 

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.

On-line Monitoring

The QI 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.

 

Top of page 

IRB SUBMISSION ASSISTANCE

To 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.   

Top of page 

ANNOTATED STUDY BINDER

To 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

Top of page 

CONSULTATION AND EDUCATION

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.

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.

Presentations

The 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 here

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

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:

Overview of BWH/MGH clinical research system

Federal regulations and guidelines

Partners clinical research policies and guidelines

Record keeping and documentation

Internship Opportunities

 

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 Delia Wolf, QI Program Director for more information.

 

Top of page