Policy for Reporting Clinical Study Serious Adverse Events
National Heart, Lung, and Blood
Institute National Institutes of Health
Effective Date: May 1, 2002
Serious
adverse events
are currently reported
by the investigator to the Institutional Review Board (IRB), Data and
Safety Monitoring Board (DSMB), Food and Drug Administration (FDA), and to the
Office of Biotechnology Activities (OBA, for gene therapy), as
appropriate. Because the National Heart, Lung, and Blood Institute
(NHLBI) is especially concerned about the safety of patients in clinical
studies that it supports, it is instituting the additional reporting
requirements described in this document.
Policy
All investigators conducting clinical studies
supported by the NHLBI must report expected and unexpected serious adverse
events to the NHLBI, as described below. Serious adverse events that will be
reported to the investigator's IRB and to the study DSMB as applicable, must be
specifically defined for each protocol and the definition approved by the
IRB.
For studies with a Data Coordinating Center,
the investigator must forward
copies of all reports of serious adverse events that are
unexpected when they are submitted to the IRB, DSMB, FDA, or
OBA.
For studies without a Data Coordinating
Center, the investigator must forward copies of all reports of
serious adverse events (expected and unexpected)
when they are submitted to the IRB, DSMB, FDA, or OBA.
Expedited
reporting is required for serious adverse events that are unexpected.
- If the unexpected
events are life-threatening or fatal, they should be reported within 7 calendar
days.
- All other serious
adverse events that are unexpected should be reported within 15 calendar
days.
Copies of reports are sent to the NHLBI Program
or Project Officer responsible for the study.
Definitions
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
Serious Adverse Events include those which:
- Are fatal or life threatening;
- Result in significant or persistent disability;
- Require or prolong hospitalization;
- Result in a congenital anomaly/birth defect;
- Represent other significant hazards or
potentially serious harm to research subjects or others, in the opinion of the
investigators.
Unexpected Serious Adverse
Events are those that have not been described in the:
- Package insert for a given drug or investigator's
brochure (for FDA investigational agents);
- Protocol; or
- Informed consent document.
Contact
For additional information contact the NHLBI Program
or Project Official associated with your study.
|