An adverse event is any undue or unplanned harm to a research participant. There are several types of adverse events that can be reported: An event that in the opinion of the principal investigator (1) was unexpected and (2) was related to the research procedures; An event that requires prompt reporting according to the research sponsor (if any); An accidental or unintentional change to the IRB approved protocol that involves risks or has the potential to recur; A deviation from the protocol without prior IRB approval to eliminate any apparent immediate hazard to a research participant; A publication in the literature, safety monitoring report, interim result, or other finding that indicates an unexpected change to the risk/benefit ratio of the research; A breach in privacy/confidentiality/data security/loss of study data that may involve risk to participant(s); A complaint of a participant that indicates an unanticipated risk or cannot be resolved by the research staff. Reporting Adverse Events To report an adverse event, please complete the Unanticipated Problems/Adverse Event Report and immediately email it to the IRB at IRB@westcoastuniversity.edu
One original copy of the form must be mailed to:
IRB/University Research Compliance WEST COAST UNIVERSITY Center for Graduate Studies 590 North Vermont Los Angeles, CA 90004
Adverse Event Reporting
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