Unanticipated problems, serious adverse events, and emergencies involving human subjects protocols approved by the CPHS must be reported and reviewed by the CPHS Requirements for reporting them are summarized below.

Unanticipated Problems

Unanticipated problems are not synonymous with “adverse events”. Unanticipated problems refer to untoward events involving any aspect of a research study, not just subjects, and can occur in clinical and non-clinical research. Some examples of unanticipated problems include:

• An investigator loses a laptop that contains confidential information about participants.
  
• A principal investigator is charged with a felony.
  
• A lab reports that blood studies performed the previous week were in error.
  
• A man physically abuses his wife because she agreed to take part in a research study without his permission.
  
• Subjects in a group counseling session become unexpectedly violent.

All unanticipated problems must be promptly reported to CPHS via iRIS.

Serious Adverse Events (SAEs)

Definitions of Serious Adverse Events

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.

Reporting SAEs to the CPHS

Serious adverse events (SAEs) must be reported promptly since some may require modification of study procedures, research protocols, and/or the informed consent forms. Before reporting a SAE to the CPHS, the investigator should assess the significance of the event in terms of risks and other human subject protection issues that will affect currently enrolled participants and future participants.

• Any death occurring while a patient is on a study must be reported to the CPHS by phone (713 500-7942) or by email to the CPHS clinical research monitor within 24 hours and via iRIS within working five days.

• SAEs or unanticipated adverse events involving investigational drugs or devices must be reported to the CPHS via iRIS within 5 working days.

• SAEs that occur within 30 days after patient involvement in the protocol must also be reported to CPHS.
  
  
• Other AEs do not need to be reported if the PI determines the AE is expected or due to the natural progression of the patient’s underlying disease.

In times of doubt (e.g. 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.

Adverse Event Evaluation/Reporting Guide

1. As defined by CPHS is the adverse event serious and 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 should fall into the categories of either
   a) serious or non-serious and
   b) expected or not expected.

Data Safety Monitoring Boards

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

Correspondence with Outside Agencies

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

If the study sponsor requires submission of 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 the CPHS 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, an IND report form must be submitted for each individual safety report within 5 working days of receipt.