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Summary of IRB / IEC

An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to make sure the protection of the rights, safety and well-being of human subjects involved during a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be employed in obtaining and documenting consent of the trial subjects.

The IRB/IEC reviews the subsequent documents: trial protocol(s)/amendment(s), written consent form(s) and consent form updates, subject recruitment procedures (e.g. advertisements), written information to be provided to subjects, investigator’s brochure, safety information, information about payments and compensation, investigator’s summary, and the other necessary documents.