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.

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. 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. 

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 developed a draft standard surrounding SAE reporting.

Complete

Public Review Period

After completing development of the draft SAE reporting standard, a public review period was held to gather industry feedback.

Complete 

Preparation for Release

Following the public review period, the CDASH Standards team finalized the industry standard and prepared for release.

Complete 

Standard Released to Industry

CDISC publishes the CDASH SAE Supplement V2.0.

Complete