Adata 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.

It is considered as an unanticipated problem.

Explanation:

An unanticipated problem occurs when an investigation arises in a situation that was not considered in advance by the investigator.

In this investigation, which is a study with drugs, the risks rise, and an unforeseen event arises. Therefore the investigator must modify the informed consent, and the subjects must reaffirm the same to continue in the study.

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