Adverse Event Information

Adverse Event Definition: An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Serious Adverse Event Definition: Any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Adverse Event Reporting
The Department of Health and Human Services (DHHS) has published regulations regarding reporting of adverse events under 45CFR46. This requires that the principle investigator follow written procedures in ensuring prompt reporting to the IRB, institutional officials, and the Department or Agency Head of any unanticipated problems involving risks to subjects. The GCRC Advisory Committee recommends that the investigator copy these reports (being sent to the funding institute and local IRB) to the GCRC RSA.

The IRB and the GCRC need to be notified promptly of any unanticipated SAE/UP that occurs with a subject enrolled in a GCRC protocol. This information will be reviewed to determine if it is safe to continue the protocol, whether protocol/consent changes are necessary, or if additional patient resources are required.

For information about Adverse Event Reporting, Forms, and Submission Requirements at Stony Brook visit the Committee on Research Involving Human Subjects (IRB) website at: http://www.research.sunysb.edu/research/humans/humansubjects.html

AE Grading/Classification
All adverse events should be categorized according to severity. Each protocol may have a unique approach to grading AEs and the P.I. should consult the master protocol and/or funding source for specific grading scales. Multi-center studies generally include such a table, sometimes called a toxicity table in the master protocol. A grading scale or toxicity table that will be used to grade AEs should be included in the Safety Monitoring Plan submitted to the GCRC with each protocol.

It is recommended that if a protocol does not already have a specific grading scale, the Common Toxicity Criteria (CTC) scale be utilized. The CTC scale may be viewed at http://ctep.cancer.gov/. Once at this website, click on Reporting Guidelines, next click on Common Toxicity Criteria, then click on Common Toxicity Criteria Document (PDF) for the actual CTC table.

Data and Safety Monitoring Boards (DSMB)
A DSMB will be required for multi-center trials and all phase III clinical (interventional) trials. A Study may require a DSMB if it involves vulnerable populations, is blinded, or is considered to be of high or significant risk. More information concerning protocols that may require a DSMB can be found in the Risk Assessment Guidelines.