Adverse Events and Serious Adverse Events

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					                           Study No. _________ Phase______

Adverse Events and Serious Adverse Events
Expedited Reporting of Serious and Unexpected Adverse Events (AEs)
For questions regarding Serious Adverse Events (SAEs), contact:

Definitions of Different Types of Adverse Events
An AE is any untoward medical occurrence in a clinical investigation patient administered a
pharmaceutical product that does not necessarily have a causal relationship with this
treatment. An AE can therefore be any unfavorable and unintended sign, finding, symptom,
syndrome, or disease* temporally associated with the use of a medicinal (investigational)
product, whether or not related to the medicinal (investigational) product. Laboratory
abnormalities and changes in vital signs, 12-lead ECG, and telemetry are considered AEs
only if they result in withdrawal from the study, necessitate therapeutic intervention, and/or
the investigator considers them to be AEs.

   *   This definition will also include intercurrent diseases and accidents observed during
       the treatment and post-treatment periods.

SAEs include any untoward medical occurrence that at any dose:
    results in death
    is life-threateningA
    requires hospitalization or prolongation of existing hospitalizationB
    results in persistent or significant disability or incapacity
    is a congenital anomaly/birth defect, or
    is another medically important conditionC

   A The term "life-threatening" in the definition of "serious" refers to an event in which
     the patient is at risk of death at the time of the event; it does not refer to an event,
     which hypothetically might have caused death if it were more severe.
   B Hospitalization for convenience does not constitute an SAE.
   C Medically important conditions that may not result in death, be life-threatening, or
     require hospitalization may be considered as SAEs when, based upon appropriate
     medical judgment, they may jeopardize the patient or may require intervention to
     prevent one of the outcomes listed in the definition above. Examples of such events
     are intensive treatment in an emergency room or at home for allergic bronchospasm,
     blood dyscrasias, or convulsions that do not result in hospitalization, or development
     of drug dependency or drug abuse.

Please note: The term "severe" is often used to describe the intensity (severity) of an event
(as in mild, moderate, or severe pain); the event itself may be of relatively minor medical
significance (such as severe headache). This use of “severe” is not the same as "serious,"
which is based on patient/event outcome or action criteria usually associated with events

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                            Study No. _________ Phase______

that pose a threat to the patient’s life or vital functions. Seriousness (not severity) serves as a
guide for defining regulatory reporting obligations.

Disease-Related AEs
The potential SAEs given below are known complications following _________________
in this patient population. Reporting of these SAEs will be required on the CRF but will not
require expedited SAE reporting, unless in the investigator’s opinion, they are “possibly
related” to study drug. Fill in complications based on the protocol.

        Cardiac                                               Liver/Hepatic Failure
        IABP Insertion                                        Ileus
        Cardiogenic Shock                                     Nausea
        Shock                                                 Vomiting
        Congestive Heart Failure                              Constipation
        Ventricular Tachycardia
        Ventricular Arrhythmia                                Infectious Diseases
        Ventricular Fibrillation                              Leg Infection
        Atrial Fibrillation                                   Urinary Tract Infection
        Atrial Flutter                                        Mediastinitus
        Supraventricular Tachycardia                          Fever
        Heart Block
        Complete Heart Block
        Myocardial Infarction

        Pulmonary Edema

        Inability to Ambulate
        Mental Status Changes


        Liver Dysfunction

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Study No. _________ Phase______

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                           Study No. _________ Phase______

Procedures for Documentation of AEs
All AEs, whether spontaneously reported by the patient or noted by the investigator,
occurring during the study must be documented, regardless of the assumption of a causal
relationship, on the respective AE page of the CRF. All events that occur from the time of
the first dose of study drug through the completion of study participation should be
documented. The investigator should ensure that all events are recorded that occurred within
at least 30 days after the last exposure to the study drug as well as any reported during the
___ and ___month follow-up telephone questionnaires.

Documentation of AEs includes
      Date of onset and offset              Actions taken
      Duration                              Seriousness
      Severity                              Outcome

The investigator should also evaluate the probability of a causal relationship of the AE to the
study medication as “definite, probable, possible, unlikely, or unrelated.” Information
provided in the Clinical Investigator’s Brochure (CIB) may support this evaluation. The
severity of common toxicities should be graded on a scale of 1 to 5, according to the
Recommendations for Grading of Acute and Sub acute Toxicities

The investigator must immediately (within 24–48 hours) report SAEs occurring or observed
during the course of the study and within 30 days of last administration of the study drug to
the ________________________drug safety contract organization:
        Tel: ________________________
        (in the event of a Death or Life-Threatening Event)
        Tel: ________________________
        Fax: ________________________

Submit the "Serious Adverse Event Report" form by fax to ______________________
within 24 hours of observation or occurrence of the SAE, whether or not complete
information is available within this timeframe. In the case of incomplete information, the
investigator must provide follow-up information as soon as possible using the SAE report

In addition, in the case of immediately life-threatening SAEs or SAEs with fatal outcome,
the investigator must inform __________________________ by phone within 24 hours
of occurrence of the SAE.

Important:     The investigator must report any SAE to the ________________ drug
               safety group and to the local IRB (according to the local IRB
               requirements) regardless of its causality.

The ________________________ drug safety group will evaluate SAE reports. The FDA
and investigators will be informed by the _________________________ as required.

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