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					                              INSTITUTIONAL REVIEW BOARD (IRB)


           REPORTING SERIOUS ADVERSE EVENTS (SAEs) AND UNANTICIPATED PROBLEMS (UPs)

A. INTRODUCTION

Federal regulations mandate that all adverse events and unanticipated problems that occur during an IRB-
approved research protocol must be reported to the IRB. In addition, the event may also need to be reported
to the study sponsor, OHRP, FDA, or other entities as applicable.

The following information provides investigators with instructions for reporting protocol specific serious
adverse events (SAEs) or unanticipated problems (UPs) during the course of a Florida Atlantic University
(FAU) research protocol. It is the responsibility of the principal investigator (PI) of any research study under
the jurisdiction of the FAU IRB to insure that these events are reported accordingly.

SAEs and UPs may affect the safety of a human subject involved in a research protocol. SAEs and UPs may
also trigger modifications to the research protocol and/or information presented to the research subjects. In
some cases, SAEs and UPs may even require that a study be halted or terminated. In order for the IRB to
make appropriate decisions concerning the protection of human subjects in research, the Board requires
sufficient reporting of research activity, including investigator’s brochures, reports from the data safety
monitoring committee, package inserts, and reports of SAEs and UPs .


B. DEFINITIONS

The definitions below are FAU IRB definitions of the terms and should be referenced when reporting adverse
events to the IRB.

      A Serious Adverse Event (SAE) is defined as an Adverse Event meeting one of the following
       conditions:
          o Results in death during the period of protocol defined surveillance.
          o Is life threatening (defined as a subject at immediate risk of death at the time of the event).
          o Requires inpatient hospitalization or prolongation of existing hospitalization during the period of
               protocol defined surveillance.
          o Results in a congenital anomaly or birth defect.
          o Results in a persistent or significant disability/incapacity.
          o Any other important medical event that may not result in death, be life threatening, or require
               hospitalization, may be considered an SAE based upon appropriate medical / psychological
               judgment, if the event may jeopardize the subject and may require medical or surgical
               intervention to prevent one of the outcomes listed above. (Examples of such medical events
               include allergic bronchospasm requiring intensive treatment in an emergency room or at home,
               blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the
               development of drug dependency or drug abuse.)

      An Unanticipated Problem (UP) is defined as any unanticipated and undesirable effect arising from
       participation in research that results in an increased risk of harm or injury to a subject or which
       suggests the possibility of increased risk to other subjects. As a simple rule of thumb, any reactions
       that are not described in the informed consent document should be considered unanticipated.
        Examples of UPs could include:
    o   Adverse emotional reactions to study procedures, such as depression or threat of harm to self or
        others.
    o   Emotional reactions that require medical, psychological or legal intervention to prevent depression,
        harm to self or others, etc.
    o   Major complaints by subjects about the safety or ethics of research procedures
    o   Failure of subject to follow approved protocol procedures which results in increased risks.

    Serious Adverse Events and Unanticipated Problems are events that represent an SAE and UP as
    defined above, occur within a study that has been approved by the FAU IRB, and must be reported to
    FAU’s IRB. Events can occur at a FAU site or at a different site conducting the same study.


C. REPORTING REQUIREMENTS
Please refer to the table below for guidance on what, when and how to submit SAE/UP reports to the FAU IRB.

             SERIOUS ADVERSE EVENTS (SAE) / UNANTICIPATED PROBLEM (UP) GUIDANCE TABLE
  Type of SAE or UP or Safety Information              When to Submit           Form to use
REPORTABLE SAEs and UPs

Any Serious Adverse Events or Unanticipated          Submit within 3
Problem (occurring within a study approved by        calendar days from        SAE / UP Form
the FAU IRB) resulting in death or a life            the date of the event
threatening experience


Any other SAE or UP occurring at an FAU site         Submit within 10
                                                     calendar days from
                                                     the date of the event


SAE or UP occurring at an external site, but         Submit within 10
within an FAU IRB approved protocol (multicenter     days of notification
trial)                                               from the sponsor

CHANGES TO STUDY MATERIALS

If SAE / UP merits changes to the protocol, Submit with the SAE /            Protocol Amendment
consent document, and/or any study related  UP request as listed             Form
materials (i.e. risks sections)             above
OTHER TYPES OF EVENTS OR SAFETY INFORMATION

Reports of Safety Alert, Data Safety Monitoring      Submit within 10        Protocol Amendment
Report, Protocol Violation / Deviation, or Audit     calendar days. See      Form
Report                                               Guidelines.

NON-REPORTABLE SAEs or UPs

Emergency Room (ER) visits unrelated to              DO NOT SUBMIT TO THE IRB
protocol intervention


Discontinuations from a study for medical            DO NOT SUBMIT TO THE IRB
reasons unrelated to protocol intervention


“For Information” only reports of AEs or UPs not     DO NOT SUBMIT TO THE IRB, unless the
related to a specific FAU protocol: Events that      report of SAE / UP merits a change in the
occur in non-protocol specific studies do not need   FAU protocol and/or consent document.
to be submitted to the IRB for review. These
events occur in studies that involve the same
investigational agent as that in a specific FAU
protocol, but occur in protocols different from
those being conducted at FAU under the
oversight of the FAU IRB.

* If a report is submitted beyond the timelines outlined by this policy, a written explanation of the delay must accompany
the adverse event form. Such explanation should include a statement describing the steps that are being taken to avoid
future delays in reporting adverse events.


D. TEMPORAL RELATIONSHIP BETWEEN SAE / UP AND A SUBJECT’S PARTICIPATION IN THE
STUDY:

                A SAE / UP is reportable if it occurs between the time that a subject is participating on a
                 protocol and for 30 days following the active intervention phase of the protocol.

                If the SAE / UP occurs more than 30 days after the active intervention has stopped, a report
                 may be necessary if there are more stringent reporting requirements set forth in the protocol or
                 mandated by the sponsor.

                The development of cancer or the identification of a congenital anomaly/birth defect in the
                 offspring of a subject who received a study drug is always reportable, even if the event occurs
                 more than 30 days after the end of the active intervention phase.
                The closing of a study does not terminate the obligation to report otherwise reportable serious
                 adverse events.



E. SPECIAL RULES FOR INVESTIGATOR INITIATED STUDIES

               All SAE and UP that occur during the performance of an investigator-initiated study (i.e., a study
                that originated with a FAU investigator) must be reported to the IRB and to the FDA if an IND
                (Investigational New Drug) or IDE (Investigational Device Exemption) has been obtained. The
                investigator assumes all responsibilities that might otherwise be assumed by an external
                sponsor (e.g. monitoring, labeling of the drug, shipping of materials, etc.). Note: NIH-funded
                studies can be investigator-initiated. Similarly, sponsors can provide funding to investigator-
                initiated studies in which the sponsor retains the IND/IDE.

               Multi-site Studies: If FAU faculty or staff coordinates a research study at multiple sites, an SAE /
                UP report (a copy of the SAE / UP form) must be sent to the IRBs at all performance sites in a
                timely fashion. Unless otherwise stated in the IRB-approved protocol, these reports should first
                be sent to the DSMB, if applicable.

               In multi-site studies being coordinated by a FAU investigator, SAE / UP report forms from
                external sites must be forwarded to the FAU investigator for submission and collation to the
                FAU IRB, unless the IRB-approved protocol stipulates that the DSMB will receive these reports
                to review prior to the report of the PI for any unanticipated problems.

               Protocol and consent modifications required for safety reasons must be communicated with the
                external sites as a “sponsor’s amendment.”

F. CONTINUING REVIEW REPORTS

               The IRB requires a cumulative report of all reportable SAE / UPs that occur within the context of
                this policy at the time of continuing review.
G. ROLE OF THE DATA SAFETY MONITORING BOARD

           Before research is approved and the first subject enrolled, the investigator(s) and the IRB
            should give careful consideration to the spectrum of adverse events that might occur in
            subjects.

           The IRB needs to receive and review significant information regarding the risk profile of the
            proposed research study. This includes the type, probability, and expected level of severity of
            the potential adverse events that may result from the study.

           The Data Safety Monitoring Board (DSMB) or an equivalent monitoring committee for an IRB-
            approved research protocol plays a significant part in the reporting of AEs / UPs. Because of the
            volume of adverse events, ranging from serious to relatively minor in nature, the DSMB is
            responsible for reviewing the AEs / UPs, determining the significance of the AEs / UPs , and
            recommending changes to be made to the approved research protocol and/or consent
            documents. If the DSMB receives an AE / UP or series of AEs / UPs that represent serious
            and/or unexpected events, the DSMB should send a report to the PIs and study sponsor in a
            prompt manner. At that time, it is the responsibility of the PI to review the report and submit an
            adverse event report to the IRB within the time frames appropriate and listed in this policy.

           If there is not a DSMB or equivalent monitoring committee for an IRB-approved research
            protocol, it is the responsibility of the PI to review adverse events and determine which adverse
            events should be reported to the IRB according to this policy.



        Approved 10/07
 this policy.


        Approved 10/07

				
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