Common Serious Adverse Events (SAE) Fields Solutions

Introduction

The Common SAE Fields Initiative is a TransCelerate-led project designed to increase the quality and comprehensiveness of serious adverse event (SAE) reports. The project focused on the assessment of the common core fields collected and reported following a serious adverse event. Upon completion of this assessment, the team proposed a list of SAE fields that would better support a complete clinical picture of a serious adverse event. As of September 2021, this initiative is complete. No new solutions or updates are planned.

Common SAE Fields Assets

Industry Standard Development

CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health.

The TransCelerate Common SAE Fields team transitioned its work to CDISC’s CDASH SAE Standard team who proceeded with the development of an industry standard surrounding SAE data collection. This SAE standard serves as an update to the existing CDASH SAE Supplement v1.0. Information concerning CDISC’s standard development process is detailed in the table below.

The CDASH SAE Supplement V2.0 can be found here.