Sample of a protocol section that addresses adverse events (AE) and AE reporting plans for an investigational drug study.

Subject Safety Monitoring

A. Adverse Event:

An adverse event is any sign, symptom, illness or experience, which develops or worsens in a subject during the course of the clinical study. The term also includes any major alteration in laboratory findings and any apparently unrelated illness, accident, or unanticipated surgery, which occurs during participation in the study.

Some examples of adverse events are:

• A change in the nature, severity frequency, or duration of a preexisting condition present before the study start.
• A deterioration in the subject’s condition due to the subject’s primary disease or a pre-existing condition.
• Development of an intercurrent illness during the study.
• Development of symptoms which may or may not be related to the use of a concomitant medication or study drug.
• Appearance of abnormal laboratory results or significant shifts from baseline, but still within the reference range, following treatment with the study drug, which is considered clinically important.

Serious Adverse Drug Experience:

A serious adverse drug experience is any adverse drug experience occurring at any dose that results in any of the following outcomes:

• Death
• A life-threatening adverse drug experience
• Inpatient hospitalization or prolongation of existing hospitalization
• A persistent or significant disability/incapacity
• A congenital anomaly/birth defect

Unexpected Adverse Drug Experience:

An unexpected adverse drug experience is any adverse drug experience that has not been previously observed, e.g., included in the investigator brochure.

2. Recording of Adverse Events:

All adverse events, whether observed by the Investigator, elicited from the subject or volunteered by the subject will be recorded. This recording will commence with the institution of protocol specific procedures and continue until two weeks after the subject receives the last dose of study medication. All adverse events will be monitored to determine the outcome.

During the subject interview on each study visit, the subject will be questioned directly regarding the occurrence of any adverse events since their last visit.

All adverse events, whether ascribed to the drug or not, will be documented. The documentation will include a description of the event, the date of onset, the date of resolution, the duration of the event, the severity, contributing factors, and any action taken with respect to the study drug.

3. Reporting of Serious Adverse Events:

To FDA and NIH

Any adverse experiences associated with the use of the drug that are both serious and unexpected will be submitted to FDA in a written IND Safety report or submitted on FDA Form 3500A. Submissions to NIH will be in accordance with the funding Institutes/Centers (IC) required format. Additionally, the NIH will be copied on all FDA reports. This information will be submitted as soon as possible and in no event later than 15 calendar days after the information becomes available.

Any unexpected fatal or life-threatening experiences associated with the use of the drug will be reported to by telephone or fax as soon as possible but no later than 7 calendar days after the information becomes available.

To IRB

Adverse events that are serious and unexpected and are related (possibly or probably) to the study must be reported within 15 calendar days. Adverse events that are both unexpected and related that are either life-threatening or result in death must be reported to the IRB immediately.

To contact the RSRB/RSRBO call (716) 275-2398
or write to: RSRBO, Box 315, University of Rochester, 601 Elmwood Avenue, Rochester, NY 14642-8315

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