Data Safety Monitoring Board definition

Data Safety Monitoring Board means the group of individuals appointed to monitor safety issues relating to the Study.
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Data Safety Monitoring Board means an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.
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Data Safety Monitoring Board or “DSMB” is a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials. The DSMB advises the sponsor regarding the continuing safety of Human Subjects and those yet to be recruited to a clinical trial, as well as the continuing validity and scientific merit of the trial. The DSMB is appointed by the Sponsor.
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Examples of Data Safety Monitoring Board in a sentence

  • SPONSOR and Institution shall consider each Trial under a respective SOW to be complete and concluded at all sites at such time as the occurrence of final data lock or earlier termination by a Data Safety Monitoring Board (“Trial Conclusion”).

  • We could encounter delays if a clinical trial is suspended or terminated by us, by the Institutional Review Board or IRB of the institutions in which such trials are being conducted, by the Data Safety Monitoring Board, or DSMB, for such trial or by the FDA or other regulatory authorities.

  • An independent Data Safety Monitoring Board (DSMB) will be chartered to review safety data to make trial conduct recommendations.

  • This study will be overseen by an independent external Data Safety Monitoring Board (DSMB).

  • Close-out visits may be conducted at study completion or earlier in the case of study termination by the IRB, <insert appropriate Safety Oversight Group or other Regulatory Body: Data Safety Monitoring Board (DSMB), FDA, etc.>.

  • SPONSOR and Institution shall consider each Study under a respective SOW to be complete and concluded at all sites at such time as the occurrence of final data lock or earlier termination by a Data Safety Monitoring Board (“Study Conclusion”).

  • Data Safety Monitoring Board: An independent Data Safety Monitoring Board (DSMB) will review safety and/or efficacy data 4 times during this study.

  • AEs shall be reported in accordance with study institution requirements, local vigilance systems, 21CFR 803 21CFR 812.46, 21CFR 812.140, and 21CFR 812.150, and ISO 14155:2011, sections 8.2.5 and 9.8. Since this is a limited pilot study, there is no Data Safety Monitoring Board.

  • An independent Data Safety Monitoring Board (DSMB) will review safety data through one interim analysis during the Phase 2 portion of the study.

  • The ICF must include a statement that data will be shared with St. Jude as the overall operations center, and the Data Safety Monitoring Board, if applicable.

Related to Data Safety Monitoring Board

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