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Adverse Events



IRB continuing review responsibilities include reviewing reports of adverse reactions and unexpected events involving risks to subjects or others.

Per CBH policy, a prompt event must meet the following criteria:  

  • Serious or life-threatening AND Unanticipated AND Related to the study OR 
  • An unanticipated / anticipated death related to the research.


And a non-prompt event must meet the following criteria: 

  • Serious / life-threatening anticipated event  OR 
  • Not serious / life-threatening anticipated event  OR 
  • Unanticipated / anticipated death NOT related to the research.  

 

If the event meets the definition of prompt, the following are required reporting timelines:

1. All problems/adverse events that are serious or life-threatening (involving risk to subjects or others), AND unanticipated AND which are related* to the study procedures must be reported, using the iRIS Prompt Reporting Event Form, within the following timeframes:

1a. If the event involves unanticipated life-threatening experiences, the event must be reported within 10 business days of the investigator’s receipt of the information.

1b. All other serious and unanticipated events/problems must be reported within 30 calendar days of the investigator’s receipt of the information.

1c. Follow-up reports on serious or life-threatening and unanticipated and related* events should be reported within 30 calendar days of the investigator’s receipt of information.

2. All unanticipated deaths and anticipated deaths related* to the study procedures occurring during a research study must be reported using the iRIS CBH Prompt Reporting Event Form according to the following timeframes:

2a. If the death is related to the study procedures it should be reported within 48 hours) by the investigator upon receipt of the information. Email notification will be accepted.

2b. If the death is not related to the study procedures (i.e., due to underlying disease progression), the death must be included in the summary of problems/adverse events submitted to the IRB at the time of continuation review in a summary format (per the instructions provided in the Continuation Review Submission form).

3. If an event does not fall under the IRB’s prompt reporting requirements, but in the Principal Investigator or Sponsor’s judgment, prompt reporting of the event(s) is in the best interest of the subject(s) (e.g., because it may affect the safety and/or welfare of subjects; or it changes the risk level of the study; or the frequency of the same event significantly increases) the PI should submit the appropriate CBH Prompt Reporting Event Form according to the applicable timeline for prompt reporting.

Any problems/adverse events that were initially determined to not be related to the study procedures and are subsequently determined related must be reported according to the requirements listed in items 1-3 above.

* If there is insufficient information to determine if the internal event is related, it should be reported as if it is related. If there is insufficient information to determine if the external event is related, it does not need to be reported until the protocol’s Continuation Review time.

 

If the event meets the definition of non-prompt, the investigator will submit the event at the time of IRB Continuing Review in a summary format (Please use the non-prompt reporting spreadsheet).