What is a DSMB charter?
Introduction. This Charter is for the Data and Safety Monitoring Board (DSMB) for the [insert protocol title, or Network title] The Charter is intended to be a living document. The DSMB may wish to review it at regular intervals to determine whether any changes in procedure are needed.
Does NIH require DSMB?
The NIH requires data and safety monitoring for all clinical trials. Multi-site clinical trials and most phase III clinical trials will require monitoring in the form of DSMBs. In June 2000, the NIH issued further guidance on data and safety monitoring for phase I and phase II trials.
What is a DSMB NIH?
The Data and Safety Monitoring Board (DSMB) is an independent group of experts that advises NIDCR. The members of the DSMB serve in an individual capacity and provide their expertise and recommendations.
Who makes up a DSMB?
DSMBs are either appointed by NIAAA and act as an independent advisory group to the NIAAA Director, or are appointed locally for investigator-initiated studies[2]. In general, the DSMB voting members are appointed by the clinical trial sponsor or by the Principal Investigator.
Do DSMB members get paid?
DSMB/OSMB members are paid an honorarium by the NIAMS for their participation in DSMB/OSMB meetings, which includes contributing their time and efforts to the review of the study materials and the ongoing review of safety reports, as well as other requests as needed.
What is a DSMB clinical?
A Data and Safety Monitoring Board (DSMB) is a committee of experts responsible for reviewing clinical trial data on an ongoing basis to ensure the safety of study subjects and validity and integrity of the data. Members should be independent, with no vested interest in a specific treatment.
What is the role of a DSMB?
A DSMB is a group of individuals with pertinent expertise that regularly reviews accumulating data from one or more ongoing clinical trials. A DSMB functions as a monitor of the trial to ensure the safety of study subjects and validity and integrity of the data. Independence is critical for DSMBs.
Who appoints DSMB?
Does my study need a DSMB?
Not all trials require an independent DSMB. Interventional research studies are prospective, human research studies that are designed to answer specific questions about the effects or impact of a particular biomedical or behavioral intervention, or are designed to answer specific questions about human physiology.
Who can be on a DSMB?
A DSMB is composed of at least three people (typically 3-10) who are not directly involved in the conduct of the study and have no financial links to the study.
Who appoints a DSMB?
Do all clinical trials require a DSMB?
Which of the following would not need to have a DSMB in place?
Studies investigating the most effective methods for the distribution of mosquito nets would not need to have a DSMB in place.
What study needs a DSMB?
As a general guideline, DSMBs are needed for clinical trials of diseases with high mortality or morbidity, for clinical trials involving high risks, and for large, multicenter clinical trials.
What is the purpose of the DSMB charter?
This Charter is for the Data and Safety Monitoring Board (DSMB) for the [insert protocol title, or Network title] The Charter is intended to be a living document. The DSMB may wish to review it at regular intervals to determine whether any changes in procedure are needed.
What happens at a DSMB meeting?
The initial DSMB meeting should occur preferably before the start of the trial or as soon thereafter as possible. At this meeting the DSMB should discuss the protocol and the DSMB Charter which includes triggers set for data review or analyses, definition of a quorum, and guidelines for monitoring the study.
Do I need a data and Safety Monitoring Board (DSMB)?
If you are conducting a multisite clinical trial involving interventions that pose more than a minimal risk to the participants, you must have a data and safety monitoring board (DSMB) to monitor the trial. For additional information, read the June 10, 1998, and June 5, 2000, Guide notices.
What does DSMB stand for?
DSMB Charter [Title of Study] [Grant or Contract Number] [PI name] [Grantee or Contract Institution] The Data and Safety Monitoring Board (DSMB) will act in an advisory capacity to the National Institute of Aging (NIA) Director to monitor participant safety, data quality and evaluate the progress of the study.