Data & Safety Monitoring Board
Data & Safety Monitoring Board at PHMC
Objective: PHMC operates a standing Data and Safety Monitoring Board (DSMB) in accordance with the National Institute of Health (NIH) policy for data and safety monitoring. Monitoring by a DSMB is required by the NIH for some clinical trials or may be required by a funder when they feel it is appropriate. The purpose of PHMC’s DSMB is to assure that the safety of study participants is protected while the scientific goals of the project are being met. The DSMB also has the authority to prematurely terminate studies when overwhelming significant benefits or risks have been uncovered or when it appears that the clinical trial cannot be concluded successfully.
DSMB Members: The DSMB is comprised of four members, three of whom are unaffiliated with PHMC. The members are experts in clinical medicine, clinical trial methodology, biostatistics, and substance use disorders. The members are responsible for monitoring the study admission, safety, and efficacy data of all PHMC-led research that requires DSMB oversight.
DSMB Administration: DSMB operations are managed by an ex officio member who serves as the DSMB Coordinator. These responsibilities include, but are not limited to, ensuring institutional compliance; ensuring DSMB members complete human subjects research training; developing and implementing policies and procedures; and communicating the DSMB’s recommendations to research personnel.
Contact: For further information on PHMC’s DSMB, please email .