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Definitions of Unanticipated Problem, Adverse Event, Serious Adverse Event and Attribution/Relatedness Scales for Defining a Study-specific DSMP

Unanticipated Problem:
Any incident, experience, or outcome that meets all of the following criteria:

    a. Unexpected in terms of nature, severity, or frequency, given a) the research procedures that are described in the protocol-related documents, such as the IRB –approved research protocol and informed consent document; and b) the characteristics of the subject population being studied;
    b. Related or possibly related to a subject’s participation in the research; and
    c. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) related to the research than was previously known or recognized” OR is SERIOUS.
    (Derived from OHRP Guidance on Unanticipated Problems and Adverse Events, Jan. 15, 2007.)
Adverse Event:
Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
(OHRP Guidance on Unanticipated Problems and Adverse Events, Jan. 15, 2007)

Serious Adverse Event:
Any adverse event that:

    - results in death;
    - is life-threatening (places the subject at immediate risk of death from the event as it occurred);
    - results in inpatient hospitalization or prolongation of existing hospitalization;
    - results in a persistent or significant disability/incapacity;
    - results in a congenital anomaly/birth defect; or
    - based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.>
    (OHRP Guidance on Unanticipated Problems and Adverse Events, Jan. 15, 2007)
Adverse Event Severity Grading Scale example:
Mild = not requiring treatment; Moderate = resolved with treatment;
Severe = inability to carry on normal activities and required professional medical attention

Other scales examples, see: World Health Organization Toxicity Criteria; Division of Cancer Therapy Evaluation Program (CTEP) Common Toxicity Criteria (CTC), version 2.0; AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events; NCI Common Terminology Criteria for Adverse Events (CTCAE, v. 3.0).

Attribution (relatedness/causality) Scale example:
The PI will determine the relationship of adverse events to the research intervention using the following scale:

    - Definite: AE is clearly related to the investigational agent/procedure/ intervention
    - Probable: AE is likely related to the investigational agent/procedure/ intervention
    - Possible: AE is possibly related to the investigational agent/procedure/ intervention
    - Unlikely: AE is doubtfully related to the investigational agent/procedure/ intervention
    - Unrelated: AE is clearly not related to the investigational agent/ procedure/intervention

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