A 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. What type of problem does this present

Question

Adeline Garrison

Business

24 September, 17:17

A 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. What type of problem does this present

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Gilbert Chavez · Answer 1

This can be classified as an unanticipated problem.

Explanation:

During an investigational drug study the rate of risk of expected adverse events is indicated to be greater than what was initially expected. The current subjects need to be reconsented and the consent form needs to be updated to include this higher rate

Since the rate of an expected adverse event is greater than what was anticipated in the beginning and puts subjects and others at risk, this poses an unanticipated problem.