Adverse Event Reporting

How to report an adverse event

It is important to notify the study team about any adverse events.

An adverse event is any undesirable and unintended effect of research occurring in human subjects as a result of participating in the QuitAid program.

Adverse events can be related or not related to their participation.
• For example, someone could develop a skin reaction to the NRT patch. That would be considered related.
• Alternatively, someone could fall and break their leg, which would be deemed unrelated to their study participation.
• Someone could also suffer a mental health related adverse event, such as severe depression. This could be deemed related or not to their participation, but the study physician would arbitrate this decision.

All adverse events, whether related or not to their study participation, need to be documented in the REDCap database, and should be notified to the study team.

Adverse events can be reported both within and outside of QuitAid sessions.

If a patient reports an adverse event either during or outside of a QuitAid Session, use the repeatable adverse event form.

If there is confusion about how to enter and address an adverse event or multiple adverse events that are reported outside of a scheduled session, please contact the QuitAid team at 434-260-9517.

Instructions

Step 1: Login into REDCap and navigate to the ‘Record Status Dashboard’ found on the left-hand menu under ‘Data Collection’.

Step 2: Click the ‘RAE’ radio button under the ‘Repeatable Events’ heading on either Arm 3: QuitAid, Arm 5: QuitAid & Quitline, or Arm 6: No Counseling tabs depending on the treatment the participant was assigned to receive.

Step 3: Complete the form with the information that the patient has provided and inform QuitAid@virginia.edu that you have submitted an adverse event form in REDCap so that a study coordinator can call the participant for more information about the adverse event.

Step 4: From the drop-down menu next to ‘Complete?’ select either ‘Unverified’ or ‘Incomplete’

‘Unverified’
• Select ‘Unverified’ if you completed the AE form with the participant and are ready for the UVA staff to review.
• Selecting ‘Unverified’ will turn the radio button yellow and will alert the QuitAid staff to adjudicate the adverse event.
• You are now done with this adverse event.

‘Incomplete’
• If you need to gather more information from the participant, for instance if you heard about an AE from someone else but need to call the participant and discuss it with them, then select ‘Incomplete’.
• Selecting ‘Incomplete’ will turn the radio button red and alert you to go back and update the information once you are able to connect with the participant.
• To access that adverse event, you will need to click on the red radio button to edit that form.
• Once it’s complete, you will ‘Save and Exit’ as ‘Unverified’.

Step 5: Remember to ‘Save and Exit’ before exiting the page when changing the status of the AE.

How to Log Multiple Adverse Events

If multiple adverse events occur (e.g., a patient was hospitalized for a fall and stomach upset), you may complete multiple AE forms. There is no limit to the number of RAE forms under the Repeatable Events tab you can create for an individual in REDCap.

Step 1: Click the plus sign icon beside the ‘RAE’ radio button under the ‘Repeatable Events’ heading on either Arm 3: QuitAid, Arm 5: QuitAid & Quitline, or Arm 6: No Counseling tabs depending on the treatment the participant was assigned to receive. A plus sign icon will only appear if a prior AE has been entered.

Step 2: Complete the form with the information that the patient has provided and inform QuitAid@virginia.edu that you have submitted an adverse event form in REDCap so that a study coordinator can call the participant for more information about the adverse event.

Step 3: Complete Step 4 and Step 5 from the Reporting an Adverse Event section of this How To Guide.