ABSTRACT

An administrative staff member will review the submission for completeness and will pass the documents to the appropriate board members for review.

B. Review of Serious Adverse Events, Including Deaths

The IRE3 will require that Investigators report all deaths that occur while the subject is participating in a research study to the IRE3 Chairperson. This must be accomplished orally within 24 hours after the death and in writing within five (5) days of the death.