Welcome to the Office of Sponsor and Regulatory Oversight (OSRO) Data and Safety Monitoring Board (DSMB) WIKI page!

OSRO is the Sponsor for CCR held INDs. Certain clinical protocols implemented under the CCR held INDs will have safety oversight by a Sponsor convened Data and Safety Monitoring Board (DSMB) or Safety Monitoring Committee (SMC) that is advisory to the CCR.  The committees will operate under a charter that describes the membership, responsibilities, and operations of data review and meeting conduct. 

Committee members will be independent and free of apparent significant conflict of interest (professional, proprietary, financial). The committees will include clinical trial experts, biostatisticians, and clinicians knowledgeable about the diseases and treatments under study. Members will be selected with expertise in disciplines and medical specialties required to interpret the data and evaluate participant safety for the studies under review.  Representatives of other clinical or laboratory specialties and the affected community may also serve as Members.  The Committee should reflect the commitment of NCI to diversity, as possible.

OSRO is supported by the Sponsor and Regulatory Oversight Support (SROS) contract.  The Safety Oversight Support (SOS), part of the SROS contract, serves as the Executive Secretary to the DSMB and facilitates all communication and activities related to the DSMB.

Meeting materials include the Meeting Agenda, DSMB Reports, and required Study documents and presentations. These materials and communications related to the DSMB meetings are provided by the OSRO Safety Oversight Committees support contractor including secure access to the Committee Management System. 

For more information regarding OSRO DSMBs, access the following:


If you have any questions, please contact SOS at SROS-SOS@tech-res.com or 202-830-2549. 
Last updated by Hestick, Jody (NIH/NCI) [E] on Feb 28, 2024