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Adverse Events

 Introduction   Definitions    Grading Scale

Current federal regulations require ongoing oversight and monitoring of adverse events in order to ensure the safety of participants and the validity and integrity of data.  A description of the plan for reporting non-serious anticipated and unanticipated adverse events as well as serious adverse events to the IRB, GCRC, funding and regulatory bodies, should be included in a DSMP.

Any unanticipated problem involving “risk” that ultimately results in harm to the subject’s rights or well-being and that is related to a research intervention constitutes a reportable adverse event.  At UTMB, all adverse events that are unanticipated and/or serious require reporting within 24 hours.  All GCRC investigators must follow the UTMB IRB Adverse Event Policy.   In addition, serious adverse events associated with GCRC protocols must be reported orally and in writing immediately by the PI (or monitor in his/her absence) to:

                                    Dr. Don W. Powell , Program Director of the GCRC

                                    Professor of Internal Medicine and Neuroscience and Cell Biology

                                    Telephone: (409) 772-0752

The PI and/or the Data and Safety Monitoring Board will make an assessment of the relationship between the adverse event and the protocol/intervention for each adverse event occurrence.  Investigators should follow the IRB terminology if available.

Definitions:

 An Adverse Event (AE): is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an experimental medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.  An Adverse Event is any experience that has taken place during the course of a research project, which, in the opinion of the investigators, was harmful to a participant, increased the risk of harm, or had an unfavorable impact on the risk/benefit ratio of the study.

Anticipated (Expected) Adverse Events: these are risks or events reported in the Investigator’s Brochure and listed in the consent form. The UTMB IRB and the GCRC will consider an adverse event as “anticipated” or “expected” only if it is discussed in the protocol and included in the Informed Consent document.

Unanticipated (Unexpected) Adverse Events:  an unanticipated adverse event is any unexpected untoward event or medical occurrence in a study subject that is not consistent with the known, predicted possible effects of the research protocol.   An unanticipated adverse event can therefore be any unanticipated, unfavorable, and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study that was not listed in the protocol, consent form or investigator’s brochure.  This includes any experience that suggests a significant hazard, contraindication, side effect, or precaution.  In addition to this definition, the UTMB IRB and the GCRC interpret any adverse event not included in the Informed Consent document as a risk to be “unanticipated” or “unexpected."  [Adapted from HHS & FDA 21 CFR 312.62 (6), 21 CFR 50.27 (a), 21 CFR 312.32 (a), FDA Docket No. 93N-0181]. 

Serious Adverse Event (SAE):  Serious adverse events are defined by regulatory criteria and include any of the following:

·    Any hospital admission (unless hospitalization is preplanned).

• Unanticipated or life-threatening drug reaction including but not limited to one that necessitates     discontinuation of study participation or that results in death

·     Congenital anomaly occurring in the offspring of a research participant who had taken a study drug

·     Exceeding the nature, severity, or frequency described in the investigator’s brochure or protocol

• Prolongs a stay in a health care facility
• Significant, persistent, or permanent harm or disability, either physical or psychological
• Death

 The NIH Web site detailing serious adverse events/effects is at: http://www.nhlbi.nih.gov/funding/policies/adverse.htm

UTMB GCRC Adverse Event (AE)Grading Scale:

The following scale grades adverse events by common features, and is often appropriate for   use by GCRC investigators where such grading is indicated.

  Note:  Investigators may use other grading scales such as the National Cancer Institute Common Toxicity Criteria, available at http://ctep.info.nih.gov.

Updated: 01/26/05