Composition of the coordinating center and trial steering committee
adverse events/unanticipated problems
A copy of the protocol, proposed informed consent form, other written subject information, and any proposed advertising material must be submitted to the institutional review board (IRB) for the lead institution for each study site for written approval. The investigator will notify the IRB of deviations from the protocol or serious adverse events/unanticipated problems occurring in accordance with local procedures. The investigator is responsible for obtaining annual IRB approval/renewal throughout the duration of the study. The IRB will be notified of the completion or termination of this study and sent a copy of the study synopsis in accordance with applicable timelines.