DSMB (Data and Safety Monitoring Board Flashcards
Regulations provide which of the following guidelines regarding data monitoring?
a) Specific guidelines for data and safety monitoring board
b) Describes the need of a DSMB in the review of serious adverse events
c) Guidelines that the IRB may substitute for a DSMB if the conditions require it.
d) Ensure that the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
d) Ensure that the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
An independent DSMB for a clinical trial reaches a decision communicated in its report that the clinical trial be stopped for safety. The DSMB report should be sent to?
a) FDA
b) IRB
c) Sponsor
d) OHRP
c) Sponsor
DSMB’s primary responsibility is to review?
a) Protocol deviations
b) The informed consent
c) Safety and efficacy at defined intervals
d) Monitoring data quality and integrity
c) Safety and efficacy at defined intervals
The decision to stop a Phase 2 or Phase 3 trial at all sites is the responsibility of?
a) FDA
b) IRB
c) DSMB
d) The investigator at the coordinating center
c) DSMB
Which of the following statements about the relationship of the IRB to the DSMB is NOT ACCURATE?
a) The IRB is not a DSMB because it only reviews serious adverse events at the institutional site whereas the DSMB reviews serious adverse events from all sites
b) The IRB is not a DSMB because it does not have the authority to unblind a subject’s identity in a clinical trial to analyze a serious adverse event whereas the DSMB does
c) The IRB can suspend a clinical trial at its own site regardless of the DSMB but the
DSMB can stop the clinical trial at all sites
d) The relative duties of the DSMB and the IRB are described in regulations
d) The relative duties of the DSMB and the IRB are described in regulations
The sponsor in a phase 2 clinical trial may?
a) Choose to delegate evaluations of safety at the site to the principal investigator
b) Carry out all evaluations of SAEs itself
c) Delegate the evaluation of SAEs to the CRO
d) Choose not to report an SAE to the FDA
a) Choose to delegate evaluations of safety at the site to the principal investigator
The frequency of meetings of the DSMB may be:
a) Based on a specified frequency in time (every six or twelve months for example)
b) Based on the number of serious adverse events observed
c) Based on the number of patients enrolled
d) All of the above.
d) All of the above
a) Based on a specified frequency in time (every six or twelve months for example)
b) Based on the number of serious adverse events observed
c) Based on the number of patients enrolled
The FDA guidance on an independent DSMB states that the sponsor should consider one for a clinical trial if the trial is?
a) Multisite and phase 3
b) Involves a vulnerable population
c) Has a complex design
d) Is pivotal for study outcome
e) All of the above.
e) All of the above
a) Multisite and phase 3
b) Involves a vulnerable population
c) Has a complex design
d) Is pivotal for study outcome
A major problem in the DSMBs for a sponsor- investigator clinical trial is?
a) Conflict of interest with the principal investigator
b) Unavailability of qualified members
c) Difficulty in IRB approval of the DSMB members
d) Difficulty in convening the DSMB and keeping minutes
a) Conflict of interest with the principal investigator
In a sponsored clinical trial, the path to reporting serious adverse events is?
a) Pl to CRO to sponsor to DSMB
b) Pl to CRO to DSMB
c) PI to DSMB
d) Pl to IRB to DSMB
a) Pl to CRO to sponsor to DSMB
If the DSMB suspends a clinical trial, the IRB:
a) Must suspend the clinical trial at its site
b) May still keep the trial open if it deems the trial is important
c) May postpone the decision to suspend until it observes what the DSMB has observed
d) May suspend new enrollment but permit continued treatment of current subjects.
a) Must suspend the clinical trial at its site
When the DSMB suspends a clinical trial it is customary for the principal investigator?
a) To keep the commitment to treat new enrollees because they have signed the informed consent
b) Keep the treatment schedule for currently enrolled subjects
c) Stop new enrollment and treatments and keep the study open only for long term follow up of existing subjects
d) Ignore the dictates of the DSMB as it does not know the events at the site in any detail.
c) Stop new enrollment and treatments and keep the study open only for long term follow up of existing subjects
