CPHS - Adverse Events

Serious & Unexpected Adverse Events (SAE)

In order to adequately protect human subjects, the principal investigator must assist the CPHS in reviewing adverse events. We ask that before adverse event reports are submitted to our office, the investigator thoroughly assess the significance of the event in terms of risks and other human subject protection issues that will affect currently enrolled as well as future subjects.

To this end, CPHS has established new guidelines to aid investigators as to the types of adverse events that must be reported to our office and timelines for doing so.

We have also instituted the use of an adverse event log which should be maintained by the investigator and submitted annually with the Continuing Review form. For every AE reported to CPHS, please utilize only one entry or line on the AE log.

For other questions, please call us at 713-500-7942.

ANIMAL WELFARE