TransCelerate Common Clinical Serious Adverse Events

Common Serious Adverse Events (SAE) Fields

The Common Serious Adverse Events (SAE) Fields Initiative conducted a feasibility assessment, developed best practices relating to
identifying the most critical SAE fields, and worked with an industry standard-setting organization to promulgate standards in this area, all with the intent of increasing the quality of what is reported and creating efficiencies for sites, CROs, and regulators. As of September 2021, this initiative is complete. No new solutions or updates are planned.

Rationale

The Common Serious Adverse Events (SAE) Fields Initiative conducted a feasibility assessment, developed best practices relating to
identifying the most critical SAE fields, and worked with an industry standard setting organization to promulgate standards in this area, all with the intent of increasing the quality of what is reported and creating efficiencies for sites, CROs and regulators.

Benefits

Supply Health Authorities and an industry standard-setting organization with a proposed common core list of SAE fields to help create an SAE data collection industry standard
Supports the complete clinical presentation of an SAE
Allows for independent clinical assessments
Positively impacts patient safety, investigators, health authorities and sponsors

Available Solutions

Initiative Solutions

Common SAE Fields Project Overview & Outputs–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.

Related Initiatives

eSource

The eSource Initiative aimed to assist sponsors in overcoming challenges in moving towards more efficient data gathering practices to benefit patients, sites and sponsors.