Adverse events can be tricky to navigate! We have made additions to our Investigator Handbook that give more detail on adverse events to help. Please see the below information on adverse events that is included in the handbook you receive when you create your study in the Axiom Mentor System.
An Adverse Events is Any unforeseen occurrence with a research participant, including any abnormal sign, symptom, or raised level of risk, temporally associated with the participants’ involvement in the research, whether or not considered related to participation in the research.
A Serious Adverse Event is an adverse event where at least one of the following outcomes is a result of the research activities:
-Life threatening condition or event
-Persistent or significant disability, incapacity, or disruption of the subject’s ability to conduct normal life activities
-Condition that investigators deem to represent significant risk or hazard to the participant
Investigators are required to report any adverse event or serious adverse events that involves human subjects enrolled in the study that are determined to be unexpected and probably, possibly, or definitely related to the test article or research procedures. This should be reported to the IRB promptly, no more than 7 calendar days after the investigators learned of the event. The IRB will then make a determination as to the relation of the adverse event and any impact on human subjects, and if further action is required on the part of the investigator. Investigators are expected to take the findings from adverse events and make appropriate changes to the protocol to ensure safety of participants.
All greater than minimal risk studies will be required to maintain an ‘Adverse Event Table’ and submit it at each annual check-in. A table template will be provided at time of initial approval.