Serious Adverse Events

How do we handle serious adverse events in REDCap?

Reporting Requirements

When conducting Health Canada regulated clinical trials involving a drug, medical device or natural health product, investigators are required to report serious and unanticipated adverse events to the local REB, study sponsor and Health Canada. Guidance, can usually be obtained from the study site's local REB. For University of Alberta investigators guidance can found on HREB's web page.

What about REDCap?

Since SAEs are not typically analyzed in academic clinical trials we do not generally collect additional data for SAEs. The standard adverse event form in the study database should be adequate since it collects all the data required for determining the reporting requirements (serious, expected, relationship to study intervention). However, SAE reports should be reconciled with the adverse event data in the study database in order to ensure that the adverse event data is accurate. For example, SAE reports may include an outcome, signs and symptoms, or a final diagnosis, that is not available at the time the adverse event is entered into the study database.

Some investigators like to include SAE details in the study database because it can be used to track reporting compliance. This may be acceptable for some studies but, since an SAE is typically followed to conclusion, it would mean that the study database cannot be locked until the follow-up of all SAEs is complete.