DSMB means the Data Safety Monitoring Board for the clinical trial that is the subject of the Project;
DSMB means a group of individuals with pertinent expertise that have oversight of and reviews on a regular basis accumulating data from one or more ongoing clinical trials and that advise the Sponsor regarding the continuing safety of Clinical Trial Subjects and those to be recruited to the Clinical Trial, as well as the continuing validity and scientific merit of the Clinical Trial.
DSMB means an independent group that reviews and evaluates clinical study data for participant safety and makes recommendations concerning the continuation, modification, or termination of a study.
Examples of DSMB in a sentence
All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well.
Studies that involve clinical trials must include a general description of the plan for data and safety monitoring of the clinical trials and adverse event reporting to the IRB, the DSMB (if one has been established for the trial), the EPA and others, as appropriate, to ensure the safety of subjects.
At this time, each data element that the DSMB needs to assess will be clearly defined.
Working committees include but are not limited to the Data and Safety Monitoring Board (DSMB), Steering Committee and Executive Committee.
Note: Phase III Clinical Trials generally require both a DSMB and a Plan.
More Definitions of DSMB
DSMB means the drug safety monitoring board for the Xxxxxxx Study. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
DSMB means an independent Data Safety Monitoring Board.
DSMB means the data safety monitoring board for the Clinical Trial;
DSMB has the meaning described in Clause 7.5.2.
DSMB means a delayed surface marker buoy (i.e.an inflatable buoy that can be deployed from depth to provide a warning to surface users and their cover boat that they are ascending or require assistance).
DSMB means the Data Safety Monitoring Board, an independent board appointed by IC to monitor the conduct and safety of NeuroNEXT clinical studies.