Data and Safety Monitoring Board an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination. The Contractor may be required to use an established BARDA DSMB or to organize an independent DSMB. All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy. The Government retains the right to place a nonvoting member on the DSMB. When a monitor or monitoring board is organized, a description of it, its charter or operating procedures (including a proposed meeting schedule and plan for review of adverse events), and roster and curriculum vitae from all members must be submitted to and approved by the Government before enrollment starts. Additionally, the Contractor must submit written summaries of all reviews conducted by the monitoring group to the Government within 30 days of reviews or meetings.
Data and Safety Monitoring Board. (DSMB) & Ethical Advisory board
Data and Safety Monitoring Board. A duly constituted Data and Safety Monitoring Board (hereinafter DSMB) has the authority and responsibility to review accumulating data from clinical investigations conducted at NIDA. The clinical investigation that is the subject of this Agreement shall be reviewed by the DSMB. The DSMB will meet on a regular basis and will review safety and efficacy data. The Principal Investigators must report all adverse drug experiences regardless of severity and must present a brief progress statement on the Study to each regularly scheduled meeting of the DSMB. The progress statement should contain an assurance that there is no evidence of safety or toxicity issues that should be addressed by the DSMB. The DSMB shall report early evidence of pre-specified or unanticipated benefit or harm to participants in the trial that may be attributable to the Agent or the treatments under evaluation in the clinical investigation. The DSMB shall conduct an independent, objective review of all accumulated data in such a manner as to maximize the benefits to the trial participants and to the research effort. The DSMB shall consider whether or not a Protocol modification is indicated based on this review, and the DSMB shall advise NIDA on the appropriateness of continuing the Study as designed. It is understood and agreed that NIDA and Collaborator shall provide clinical trial data to the DSMB, in the format specified by the DSMB, three (3) weeks prior to the meeting dates established and specified by the DSMB. It is further understood and agreed that NIDA will format the data for submission to the DSMB through the statistical center contracted by NIDA, as supplied by participating clinical trial sites on a schedule to be specified by the statistical center. It is further understood and agreed that both Collaborator and NIDA will have key trial personnel available to meet with the DSMB and provide information, if so requested, and agree to abide by final decisions of the DSMB.
Data and Safety Monitoring Board. To ensure that appropriate ethical consideration is given to the welfare of the patients enrolled in the study, NINDS-NIH has appointed a Data and Safety Monitoring Board (DSMB) to oversee the trial. The DSMB will review the incidences and circumstances of adverse events that occur during the course of the trial. Formal interim analyses will occur after 25%, 50%, and 75% of patients have been enrolled. The members of the DSMB are: Xxxxx Xxxxxxx, MD (Chair) - Professor and Chair of Neurology, University of Texas, San Antonio, Stroke Neurologist Xxxxx Xxxxxxxx, MD - Associate Professor of Neurology and Health Evaluation Sciences, University of Virginia, Stroke Neurologist and Health Outcomes Specialist Xxxxxx Xxxxxx, MD - Assistant Professor of Neurology, Xxxx Xxxxxxx, Stroke Neurologist Xxxxx Xxxxxxxxx, MD - Associate Professor of Neurology, University of Texas, San Antonio, Stroke Neurologist Xxxxxxx Xxxxxx, PhD - Professor of Biomathematics, University of Iowa, Statistician
Data and Safety Monitoring Board. This award is subject to the NIDA Guidelines for Establishing and Operating a Data and Safety Monitoring Board.
