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.

Common SAE Fields Assets

Asset
Description
A set of slides detailing the initiative’s background, its methodology for creating a core list of Common SAE Fields, and overview of the initiative’s outputs

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. Eventually, this SAE standard will serve as an update to the existing CDASH SAE Supplement v1.0. Information concerning CDISC’s standard development process is detailed in the table below.

Development Stage
Description
Status
Standard Scoping & Pre-Work
The Common SAE Fields Team transitioned its assets to CDISC as part of its project plan. CDISC used these as inputs to better inform their project scope.
Complete
Draft Standard Development
The CDASH Standard Development team is currently developing a draft standard surrounding SAE reporting. Expected development time is 3 to 4 months.
In Progress
Public Review Period
After completing development of the draft SAE reporting standard, a public review period will be held to gather industry feedback.
Not Started
Preparation for Release
Following the public review period, the CDASH Standards team will finalize the industry standard and prepare for release.
Not Started
Standard Released to Industry
The SAE reporting standard has not yet been released. It is expected to be available in 2020.
Not Started