HSR Safety and Compliance 4

Question 1

Under the Common Rule IRB approval criteria, what must research plans include 'when appropriate'?

Accepted Answer

Adequate provision for monitoring the data collected to ensure the safety of subjects

Answer

45 CFR 46.111(a)(6) requires, when appropriate, adequate provisions for monitoring data to ensure subject safety.

Question 2

NIH policy generally requires a Data and Safety Monitoring Board (DSMB) for which type of study?

Accepted Answer

Multisite clinical trials involving interventions that entail potential risk

Answer

NIH requires DSMBs for multisite clinical trials with interventions posing potential risk to participants.

Question 3

Which characteristic is most important for DSMB members?

Accepted Answer

They are independent of the study and free of significant conflicts of interest

Answer

DSMB independence ensures objective review of accumulating safety and efficacy data.

Question 4

In a blinded randomized trial, who typically reviews unblinded interim safety and efficacy data?

Accepted Answer

The DSMB

Answer

The DSMB reviews unblinded interim data while investigators remain blinded to protect trial integrity.

Question 5

Prespecified stopping rules in a clinical trial protocol are used to:

Accepted Answer

Define criteria for terminating the trial early for harm, overwhelming benefit, or futility

Answer

Stopping rules give objective thresholds that trigger early termination to protect participants or avoid futile research.

HSR - Human Subjects Research Certification Practice Test