MUSC IRB Reporting Requirements for Adverse Events

Adverse Events On-line Form

Below is link to a statement from the IRB regarding changes in external adverse event reporting:
Statement of Change in Reporting External Adverse Events to the IRB

See Flow Charts for help:
Reportable Internal Events Chart
Reportable External Events Chart

Reportable Adverse Events and Unanticipated Problems

Internal Adverse Events

Internal events include Drugs, Biologics, Devices, Loss of Confidentiality, Privacy Issues or Harm to Others: An unanticipated and related or possibly related, serious or more prevalent event occurring during a research study. Report on-line as soon as possible but no later than 10 working days after the investigator first learns of the event.

Fatal - Internal: Report all that occur during the study or 30 days post termination from protocol. Report whether expected or unexpected, related, possibly related or unrelated. Reports must be submitted on-line as soon as possible, but no later than 10 working days after PI learns of the event.

External Adverse Events

External events include Drugs, Biologics, Devices, Loss of Confidentiality, Privacy Issues or Harm to Others: Report on-line as soon as possible but no later than 10 working days after the investigator first learns of the event.

The following conditions must be met for an external adverse event to be reportable to the IRB. 

1. The event has been reviewed by the Central Monitoring Entity (CME) for the study (e.g., a Data Safety Monitoring Board (DSMB) or a Data Monitoring Committee (DMC), a coordinating or statistical center, or other sponsor monitoring entity – see definition below). 
2. The central monitoring entity has determined that the particular adverse event or series of adverse events represent(s) an unanticipated problem which involves risks to subjects or changes the risk/benefit ratio for the study.
3. The external AE report includes the decision of the central monitoring entity regarding recommendations for action.  Examples of such recommendations might include modification of inclusion or exclusion criteria to mitigate the newly identified risks; implementation of additional monitoring procedures of subjects; termination of enrollment of new subjects; modification of informed consent documents to include a description of newly recognized risks; and provision of additional information about newly recognized risks to previously enrolled subjects. 

For any report of an external adverse event determined not to be an unanticipated problem, the local investigator maintains a copy of the external adverse event report and documentation of the basis for this determination.  Local investigators should document their analysis of all external AEs, and this documentation is subject to review or audit by the IRB or designated compliance arm.

See the following site for:

1. Examples of Adverse Events that Do Not Represent Unanticipated Problems and Do Not Need to be Reported (Appendix B), and
2. Examples of Adverse Events that Represent Unanticipated Problems and Need to be Reported (Appendix C).
   http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm

Fatal - External: Report all that occur during the study or 30 days post termination from protocol only if they meet reportable criteria above. 

Definitions:

Central Monitoring Entity (CME):  The group charged with reviewing the accumulated data to monitor safety, effectiveness, and trial conduct issues as the trial progresses.  This group receives and analyzes all adverse events and other reports for the purpose of identifying and communicating important new safety information. 

Clinical trials may identify a Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) as the central monitoring entity. 

MedWatch, the FDA Safety Information and Adverse Event Reporting Program, is not a central monitoring entity. 

Unanticipated Problem:  An unanticipated problem may be identified in various ways, one of which is an adverse event.  “Unanticipated problems involving risks to human subjects or others” include those events that (1) are not expected given the nature of the research procedures and the subject population being studied; and (2) suggest that the research places subjects or others at greater risk of harm or discomfort related to the research than was previous known or recognized. 

Unexpected / Unanticipated (adverse event): Not identified in nature, severity or frequency in the current protocol, informed consent, investigator brochure or with other current risk information.

Serious: Results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, cancer, overdose or causes a congenital anomaly/birth defect.

More Prevalent: Adverse events that occur more frequently than anticipated or are more prevalent than expected. Example: nausea noted in consent as occurring in 10% of subjects - if 35% of subjects experience nausea, then report as an adverse event.

All other (expected adverse events): Report as aggregate data at time of continuing review.

Related:There is a reasonable possibility that the adverse event may have been caused by the drug, device or intervention.

Possibly Related: The adverse event may have been caused by the drug, device or intervention, however there is insufficient information to determine the likelihood of this possibility.

To access the Adverse Event on-line form click here.

If you have questions or are experiencing difficulties regarding Averse Events, call the IRB Office at 792-4148.

Internal Use of Adverse Event Form (Only for IRB Office)