SOGI PROTOCOL IMPLEMENTATION STANDARDS
SOGI Protocol Implementation Standards
Draft Version 1.0 · 2026 · Draft for Public Comment
Binary demographic assumptions embedded in clinical trial protocols create structural data integrity failures — not gaps in representation, but failures in safety signal detection, adverse event coding, and regulatory submission accuracy.
This standard provides the execution-ready operational infrastructure to fix that. Protocol writers, data managers, biostatisticians, and regulatory teams can implement it directly, without translation.
Open for Comments until 31st August 2026
| Document | SOGI Protocol Implementation Standards |
| Standard Code | SGMA-STD-001 |
| Version | Draft Version 1.0 (2026) |
| Status | Draft for Public Comment |
| Publisher | SGMA (Scientific Governance and Measurement Authority) |
| License | Creative Commons Attribution 4.0 International (CC BY 4.0) |
| Standards Architecture | SGMA-ARC-001 |
| Related Standards | SGMA-STD-002 · SGMA-STD-HIV-001 · SGMA-GOV-HIV-CV-001 · SGMA-GOV-PP-001 |
Cite This Document
SGMA. SOGI Protocol Implementation Standards. SGMA-STD-001. Draft Version 1.0. 2026. sgmastandards.org/sogi-protocol-implementation-standards
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