All clinical research projects submitted for IRB approval must have an appropriate plan for data and safety monitoring. In some cases, this will require periodic review of data pertaining to participant safety and study integrity by an independent review
Having a DSMB in place will ensure subject safety and data integrity, and it will speed up your IRB approval.
DSMBs are made up of multidisciplinary members knowledgeable in the conduct of research, including backgrounds in biostatistics, clinical trial methodology, bioethics and relevant medical and scientific specialties. These committees play a unique role in ensuring the safety of human subjects enrolled in trials. While many sponsoring agencies will provide such oversight committees, some projects will require, but do not have in place, an independent data and safety monitoring board.
Under the expert leadership of Dr. Barbara Hammack, one of the editors of the recently published DSMB Training Manual, the CCTSI will assist with the establishment and administration of the DSMB for your study. This resource alleviates the associated administrative burden and need to recruit individual board members.
Costs are handled on a case-by-case basis and are determined by the complexity of the study and the funding source.
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