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.

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

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.

Similar Initiatives

eSource

The eSource Initiative seeks to assist TransCelerate Member Companies, and ultimately other trial sponsors, in overcoming real and perceived challenges to influence more efficient data gathering practices to benefit patients, sites and sponsors.