Instructions Local Adverse Event Form (Initial)

Definitions:

An adverse event (AE) is defined as any occurrence in the health or well being of a research participant who is administered an investigational product (drug, natural health product, or device) or any other procedure(s) involved in the research or participates in a research activity that may or may not be caused by the administration of an investigational product or any procedure(s) involved in research

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

  • Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the REB-approved research protocol and informed consent document, or the Investigator Brochure; and (b) the characteristics of the research participant population being studied; and
  • Related or possibly related to participation in the research, (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the investigational product(s) or procedures involved in the research); and
  • Suggests that the research places research participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

A serious adverse event (SAE) is an adverse event that:

  • Results in death; or
  • Is life threatening; or
  • Requires in-patient hospitalization or prolongation of existing hospitalization; or
  • Results in persistent or significant disability or incapacity; or
  • Causes congenital malformation/ birth defect; or
  • Any other adverse event that, based upon appropriate medical judgment, is an important medical event that may jeopardize the health (physical, psychological, economic, or social) of the research participant or may require medical intervention to prevent one of the outcomes listed above.

Local (Internal) adverse event:  local adverse events are those adverse events experienced by research participants enrolled by the investigator(s) at one or more centers under the jurisdiction of the University of Manitoba REB.  In context of a single-centre clinical trial, all adverse events would be considered local adverse events.

Criteria and Submitting Instructions:

  • Report only those local adverse events that are considered unanticipated problems (i.e. unexpected, related or possibly related and places participants at greater risk).
  • The reporting requirements apply to non-intervention trials as well as intervention (clinical) trials.
  • Complete and submit two (2) copies of the Bannatyne Campus Local Adverse/Unanticipated Problems Form (Initial) to the REB office.  Include a self addressed (postage attached for external mail) returned envelope.
  • Submit all fatal or life-threatening adverse events that are unexpected and related or possibly related (i.e. unanticipated problems) to the REB within seven (7) days of becoming aware of the event.
  • Submit all other unanticipated problems (local) and reportable adverse events to the REB within fifteen (15) days of becoming aware of the event.
  • Serious adverse events must also be reported to the study sponsor as the sponsor is responsible for submitting safety information to applicable regulatory authorities.
  • When the study is funded by the US Department of Health and Human Services (e.g. NIH, CDC, etc) the sponsor or lead PI is also responsible to report the unanticipated local adverse event and other local unanticipated problems to the applicable agency head (or designee) and the Office of Human Research Protections within one (1) month of becoming aware of the event on behalf of the University of Manitoba or applicable institution.
  • Incomplete submissions/documents or submissions that do not meet the criteria listed above will not be processed and will be returned to the sender.
  • Changes required to the protocol or consent form as result of the unanticipated problem/ adverse event(s) must be submitted using the Bannatyne Campus Amendment Form.
  • Do not include a cover letter with the submission.
  • Faxed or e-mail submissions are not accepted.