According to federal regulations, the CPHS must review reports of serious and unexpected adverse events (SAEs) for subjects participating in studies approved by the CPHS. In addition to the CPHS, the obligation to review adverse event reports is also shared by the individual investigators, the sponsor's interim safety committee, the Data Safety Monitoring Board (DSMB), and/or the FDA.

Prompt reporting is required since some SAEs may require modification of study procedures, research protocols, and/or the informed consent forms. It is the responsibility of principal investigators to report in writing any serious adverse events or unanticipated adverse events associated with the use of either investigational drugs or devices to the CPHS within 5 working days.

Any death occurring while a patient is on a study must be reported by phone (713-500-7942) to the CPHS within 24 hours and in writing within working five days.

Other SAEs do not need to be reported if the investigator has determined that the SAE is expected or due to the natural progression of the patient’s underlying disease.

In times of doubt, for instance when at the time of the event it cannot be determined whether the SAE is a consequence of the study procedure, the SAE must be reported to the CPHS. If there is a clarification/change to any of the information initially submitted, provide a follow-up report.

A serious adverse event (SAE) is any adverse experience occurring during the course of the study or during planned follow-up. Any adverse event that meets any of the following criteria MUST be reported to the CPHS:

• results in death;
• is life-threatening (places the patient at immediate risk of death from the experience as it occurred);
• results in a persistent or significant disability/incapacity (substantial disruption of one’s ability   to carry out normal life functions)
• results in medical or surgical intervention
• results in OR prolongs an existing inpatient hospitalization (even if the hospitalization is a precautionary measure for observation);
• is a congenital anomaly/birth defect in offspring of subjects taking the product regardless of time to diagnosis;
• is a cancer;
• is the result of an overdose, whether intentional or accidental, including a breach of protocol;   or,
• is medically unexpected, regardless of severity

An unexpected adverse event is any adverse event that is not consistent with the currently approved research protocol, investigator brochure, or informed consent form, or one that is not part of the normal disease progression.

An expected adverse event may qualify as “unexpected” and therefore be reportable IF the expected adverse event occurs more frequently than normal.

Adverse events that have occurred at other sites must be reported only if they are both serious and unexpected and probably related to the research.

For research projects that have a DSMB, it is the responsibility of the principal investigator to provide the CPHS with any correspondence regarding an adverse event from the DSMB within 5 working days of its receipt by the PI.

All correspondence with outside agencies (FDA, NIH, etc.) regarding adverse event reports are required to be submitted to the CPHS within 5 working days.

If the study sponsor requires you to submit an adverse event report to the CPHS, please note that it is your responsibility as the investigator to review any and all reports and ONLY forward to this office those adverse events that are both serious and unexpected and are judged to be related or possibly related to the study drug. If this is the case, you must complete and submit one SAE form for each individual safety report within 5 working days of receipt.

CPHS does not accept adverse event reports of off-site subjects that are either expected or not serious.

CPHS now requires the use of an adverse event log which should be maintained by the investigator and submitted annually with the Continuing Review form. The form is available through iRIS system. A copy will also be attached to the Continuing Review forms in the future. For every AE reported to CPHS, please utilize only one entry or line on the AE log.

1. As defined by CPHS is the adverse event serious and/or unexpected?
   Yes=> Use the Report of Serious Adverse Event, Injury, or Unexpected Problem Form found in the iRIS system.
   No => Proceed to next question

2. As defined by CPHS is the adverse event serious but expected?
   Yes => Use the Report of Serious Adverse Event, Injury, or Unexpected Problem Form found in the iRIS system.
   No => Proceed to next question

3. As defined by CPHS is the adverse event expected and not serious?
   Yes => You do not have to report an expected and/or non-serious adverse event to the CPHS.
   No => If you are still not certain, please re-evaluate this adverse event to determine if it since it should fall into the categories of either
   a) serious or non-serious and
   b) expected or not expected.