Thus, findings from the respective data review have consequences, and these need to be clearly defined. Most commonly, findings from pharmacovigilance-related data review result in queries to the site to provide clarification and/or additional information, and in turn these data constitute a novel data status that needs to be checked in a respective time frame.
All of the above listed examples require many different eCRF and reporting functionalities. For instance, SAE information is usually forwarded in form of individual e-mail alerts for review. In contrast, non-serious events might be better monitored in an aggregated way e.g. by means of incremental and/or cumulative line listing. And yet again, the surveillance for “hidden” AE information might employ both approaches, i.e. real time alerts and aggregated listing review.
The important aspect here is that, especially with EDC projects, many steps need to be considered during the set-up of the study, which usually is prone to extensive time pressure.
We feel that for a smooth process and EDC set-up the following consideration check-list has proved helpful when applied early in the project: