Adverse Events, Unanticipated Problems and Protocol Deviation In Clinical Trials.

It is imperative that the investigator assess AE causality in terms of overall study participation and make an independent determination as to whether the AE was thought to be related to any study-related activity (i.e., study intervention, test article administration, study-related tests or procedures). Investigators are required by law to inform the IRB and other entities (such as governmental or other sponsors) of any AE or other safety-related information in accordance with each entity’s regulations, policies and guidelines. • Evaluate an AE’s impact on the risk/benefit ratio of the study • Evaluate whether new information may affect participants’ willingness to continue participation in the study, and if so, inform participants of new information according to a plan described to the HRPP • When appropriate make changes to the informed consent document and/or IRB Application/protocol resulting from an AE, and submit a modification to the IRB for review and approval • When appropriate, ask