Reporting unanticipated problems or study deviations
ADVERSE EVENT
Any protocol deviation or adverse event that meets reporting requirements of the Institutional Review Board (IRB) will be reported to the Johns Hopkins IRB, and a de-identified report will be submitted to the CDC. All deviations from the protocol will be addressed in the study participant source documents. The documentation will include the reason(s) for the deviation and all attempts made to prevent or correct the deviation. The study team will complete a Protocol Deviation Form documenting each protocol deviation. A complete copy of the Protocol Deviation Form will be maintained in the regulatory file as well as in the participant’s source documents.