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Business, 16.07.2019 18:20 jellyangie1
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. what type of problem does this present
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