IRB Adverse Event Reporting Form

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					                                              Institutional Review Board
                                             Adverse Event Reporting Form

      Adverse Event Reporting Guidelines:

      Since the IRB is responsible for the continued assessment of the risks versus benefits of research
      involving human subjects, investigators are required to notify the IRB of adverse events (AEs) that
      have been designated serious and unexpected.

      An Adverse Event is defined as any unfavorable and unintended sign (including abnormal laboratory
      finding), symptom, or disease temporally associated with the use of a medical treatment or procedure,
      regardless of whether it is considered related to the medical treatment or procedure.

      Serious Adverse Events (SAEs) are any adverse experiences occurring that result in any of the
      following outcomes: death, a life-threatening adverse experience, inpatient hospitalization or
      prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital
      anomaly/birth defect. Death is never expected.

      An Unexpected Adverse Event (UAE) means any adverse experience that is not identified in nature,
      severity or frequency in the current investigator brochure, study protocol, or consent form. (CFR
      312.32 (a)).

        Two types of SAEs are identified:

      Internal Adverse Event if the event is serious and unexpected and has occurred to a subject enrolled
      at AUB/AUBMC, and/or other research site under the jurisdiction of AUB and is associated with the
      research intervention. The PI is required to report the event directly to the IRB and to the Sponsor
      within 10 days of the PI’s knowledge of the event.

      External Adverse Event if the event is serious and unexpected and has occurred at an external site
      and is reported to the IRB or to the PI by external sponsors of multicenter studies and is associated
      with the research intervention. The PI typically receives notification of these events from the sponsor.

      The definition of an SAE may vary depending on whether the research involves a drug, investigational
      device or research-related invasive procedure.

      An investigator shall promptly report to the sponsor any adverse effect that may reasonably be
      regarded as caused by, or probably caused, by the drug. If the adverse effect is alarming, the
      investigator shall report the adverse effect immediately (CFR 312.65 (b), for drug related SAE).

      An investigator shall submit to the sponsor and to the IRB a report of any unanticipated adverse device
      effect occurring during an investigation as soon as possible, but not later than 10 working days after
      the investigator first learns of the effect (CFR 812.150 (a), for device related SAE).

      The IRB will review all serious adverse event reports to reevaluate the risks ad benefits of the
      research, need for changes, etc. Principal investigators will be notified of any action taken.

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      Please Complete the following information:

      Date of the report:
      Principal Investigator:                  Department:                          Phone #:

      Protocol Number:                         Protocol Title:

      Patient Number:                          Patient Initial:                     Case Number at
      (if applicable)                                                               AUBMC:
                                                                                    (if applicable)
      Subject’s Age:                           Gender:

      Date of the Event:             Is the Event continuing: — Yes              — No*
                                     *If No: Date of Event Termination:

      Is this a new Report? — Yes             — No* (it is a follow up report)
      * If No, Date of the First Report:

      Description of the Adverse Event:

      Briefly describe the adverse event. Include patient’s demographics and pertinent medical information
      (e.g., diagnosis, physical exam, lab values, concomitant medications, etc.), treatment the subject
      received before and after the event (if applicable), subject’s prognosis, and final outcome, including
      whether the subject remains on study.
      NB: If the event occurred to a subject at another site, the PI can attach the form provided by the
      sponsor in place of the description.

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      Treatment provided to the subject:

         Date of Treatment:
         Describe the treatment provided to the subject:

         Describe the outcome of treatment:

      The Event/problem was:

      —   Mild (transient or mild discomfort (< 48 hours); no medical intervention/therapy required)
      —   Moderate (mild to moderate limitation in activity; minimal medical intervention required)
      —   Severe (Marked limitation in activity; medical intervention/therapy required)
      —   Resulted in hospitalization or prolonged hospitalization
      —   Resulted in permanent disability
      —   Resulted in Death (Date of Death:                  )

      Relationship to Research intervention:

      — Highly probable (the AE has a timely relationship to the study procedures and follows a known
        pattern of response for which no alternative cause is present)
      — Probably related (the AE has a timely relationship to the study procedures and follows a known
        pattern of response for which a potential alternative cause may be present)
      — Possibly related (a causal relationship can not be eliminated)
      — Unlikely (there is a low probability that the research intervention caused the AE) or (another
        causative alternative exists to account for the AE)
      — Assessment not provided.

      Describe the suspected cause of the Adverse Event:

      — Underlying disease:
      — Concomitant medication/drug:
      — Disease progression:
      — Procedure:
      — Other. Specify:

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      Protocol Data:

           Is this a:     — Therapeutic protocol             — Non-Therapeutic protocol
           Is this AE (Adverse Event) listed in the investigator brochure? — Yes              — No
           Is this AE listed in the protocol?                              — Yes              — No
           Is this AE listed in the informed consent form?                 — Yes              — No
           Has this AE previously occurred on this protocol?               — Yes*             — No
            *If yes, how many times?
           Has the sponsor provided any data on the frequency of this AE? — Yes*               — No
            *If yes, please attach to this report.

      Changes necessitated by AE:

           Are any changes required in the informed consent/assent document(s) to better inform and protect
            the rights and welfare of subjects?

            — Yes*               — No (why? :                                                 ).
            *If yes, please attach a revised consent/assent form with changes highlighted.
           Is it necessary to inform subjects/legally authorized representatives who have already consented to
            participation in the study of the event or problem?
            — Yes. It will be done and documented (if a change has been made in the consent form, the new
            form must be signed)
            — No (why? :                                                                   ).


      Principal Investigator’s Signature                                      Date

                                                  IRB Comments

          — The IRB took note of the AE and did not request any action
          — The IRB requests modifications as follows:

          Chairman’s Name and Signature                                    Date

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