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Clinical research studies at Massachusetts General Hospital are monitored on a regular basis to ensure that they are being conducted in compliance with both federal regulations and study protocols.
If you are working on an industry-sponsored drug, device or biologic study, your project is likely to be monitored by the study sponsor on a regular basis.
The clinical research monitor (CRM) is responsible for the timely and accurate monitoring of all research subject data and study-related information from source documents and research records.
Additionally, the CRM works closely with the clinical research team to ensure that federal regulations and study protocols are adhered to and that all research is properly completed and accurately documented in a timely manner.
According to the Record Keeping and Record Retention Requirements of the Partners Human Research Committee (PHRC)—the institutional review board (IRB) for Massachusetts General Hospital—research records should be stored for at least seven years after the completion of the research study or longer if required by the sponsor.
It is also important to remember that the PHRC Protocol Summary has a safety monitoring and quality assurance section that must be adhered to during all phases of study execution. This and all other aspects of your study will be reviewed during monitoring visits.
Regular site monitoring visits can be broken down into four types: pre-study visits, initiation visits, periodic monitoring visits and close-out visits. For more information about these types of visits and what is required during each, please review the Clinical Research Program’s (CRP) study procedures documentation.
Monitor Online Record Access (MORA) is a Partners-specific program which permits external monitors to review medical records of subjects enrolled in your clinical research study.
If you are the Principal Investigator on a federal/non-profit-funded study, you are considered the study sponsor. As such, you are required to monitor your study and should plan for this accordingly.
The United States Food and Drug Administration (FDA) may inspect your clinical research records. FDA inspections occur with little warning and without much time to prepare. The Partners Human Research Quality Improvement (QI) Program and the PHRC can help you prepare for an FDA visitation once you are notified that an inspection will take place.
The Division of Clinical Research (DCR) at Mass General helps to connect investigators and study staff members to a variety of courses, services and resources that provide assistance with every step of the clinical research process. These include offerings from the DCR itself, as well as associated research institutions and organizations. Mass General resources are listed first; DCR programs are noted in parentheses
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