SOGI Business Case
Comprehensive Case for SOGI Data Collection in Clinical Research
Version 2.0 · 2026 · Active
SOGI data are not routinely collected in clinical research. This is more than an absent demographic field — it limits what trials can detect about safety and efficacy, what regulatory submissions can characterize, and what real-world practice can be informed by.
This document gives clinical research and healthcare professionals at pharmaceutical companies the consolidated scientific and operational case for SOGI data collection. Implementation specifications are set out in SGMA-STD-001 (SOGI Protocol Implementation Standards) and the controlled vocabulary in SGMA-STD-002 (Population Classification Standard).
| Document | Comprehensive Case for SOGI Data Collection in Clinical Research |
| Version | 2.0 (2026) |
| Status | Active |
| Publisher | SGMA (Scientific Governance and Measurement Authority) |
| License | Creative Commons Attribution 4.0 International (CC BY 4.0) |
| Companion Standards | SGMA-STD-001 · SGMA-STD-002 |
Cite This Document: SGMA. Comprehensive Case for SOGI Data Collection in Clinical Research. Version 2.0. SGMA; 2026. sgmastandards.org/sogi-business-case
Lauren B. Beach · Amanda Beasley · Craig Davenport · Terttu E. E. Haring · Jackie Kent · Garo Kiledjian · Evan Ko · Kelly McKee · Meghan McKenzie · Lisa Moneymaker · Madeline Ormand · Jirair Ratevosian · Donna Sattler · Kemi Williams · Benjamin Young
Authors listed alphabetically by surname. Authorship determined under SGMA-GOV-PP-001, applying ICMJE criteria.
