Manage monitoring requirements
- If you are working on an industry-sponsored drug, device or biologic study, your project will likely be monitored by the study sponsor on a regular basis.
- The Clinical Research Monitor 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 Clinical Research Monitor works closely with the clinical research team to ensure that protocols are adhered to and that all research is accurately completed and documented in a timely manner.
- PHRC Record Retention requirements state that Research records should be stored according to the Partners Human Research Committee (PHRC) Record Keeping and Record Retention Requirements 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 click here.
- 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. For instructions about how to access MORA please click here. For more information contact the MGH Clinical Research Program.
- 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 US Food and Drug Administration (FDA) may inspect your clinical research records. FDA inspections occur with little warning and without much time to prepare. It is vital that you let the Partners QI Program and the Partners Human Research Committee know as soon as you are notified that the FDA is coming as they can help prepare you for this visit.
▪ Introduction to Clinical Research at MGH
▪ An Overview of Monitor Online Record Access (MORA)
▪ Audit Time: Is your Site Prepared?
▪ Clinical Research Program Spotlight Series: Developing a Peer to Peer Auditing Program
▪ FDA Inspections, 483s and Warning Letters: How to Avoid and Survive Them
▪ Good Clinical Practice in Research at an Academic Research Institution
▪ Hands-on MORA Training: Managing Monitor Online Record Access