question 5\na data safety monitoring board report for an investigator - initiated investigational drug study…

question 5\na data safety monitoring board report for an investigator - initiated investigational drug study indicates a significantly higher than anticipated rate of an expected adverse event. this event required revision of the informed consent form to disclose the higher rate. a change in the eligibility criteria of the protocol to reduce the risk was implemented. current subjects would be reconsented.\nthis study was an investigator - initiated study. there is no need to report to the irb or any federal agency.\nthis is not an unanticipated problem because the adverse event was acknowledged in the consent form.\nthis is an unanticipated problem.\ncurrent subjects should never be reconsented.

question 5\na data safety monitoring board report for an investigator - initiated investigational drug study indicates a significantly higher than anticipated rate of an expected adverse event. this event required revision of the informed consent form to disclose the higher rate. a change in the eligibility criteria of the protocol to reduce the risk was implemented. current subjects would be reconsented.\nthis study was an investigator - initiated study. there is no need to report to the irb or any federal agency.\nthis is not an unanticipated problem because the adverse event was acknowledged in the consent form.\nthis is an unanticipated problem.\ncurrent subjects should never be reconsented.

Answer

Brief Explanations:

The adverse event had a higher - than - anticipated rate. Even though it was an expected event, the significant increase in rate makes it an unanticipated problem. Informed consent form needed revision and eligibility criteria were changed, and re - consenting current subjects is a proper step. Also, investigator - initiated studies still need to follow regulations and report to relevant bodies like IRB.

Answer:

This is an unanticipated problem.