A Risk Mitigation Plan Might Include

Question: The type of member expertise needed on almost all DSMBs includes:

Answer: Statistics

Question: The only type of trial for which FDA regulations mandate a DMC is:

Answer: A trial of emergency research using an exception from the informed consent requirement

Question: DSMB members should have

Answer: No significant conflicts of interest

Question: A DSMB’s operational procedures are written down in a:

Answer: Charter

Question: Which of the following statements about IRBs and DSMBs is true?

Answer: They have overlapping responsibilities for trial oversight

Question: Confidentiality of the interim results of a randomized trial is important because:

Answer: Revealing interim results may affect the conduct of the study and lead to biased results

Question: The optimal size of a DSMB depends on:

Answer: The study’s complexity

Question: : A DSMP includes a safety monitoring plan and what other component?

Answer: Data management plan

Question: A risk mitigation plan might include

Answer: Criteria for reducing a subject’s medication dose

Question: A DSMB’s operational procedures are written down in a:

Answer: Charter