Population Standards
There are currently no validated standards governing which populations are included in clinical research and healthcare — or how they are characterized and measured. SGMA exists to change that.
SGMA’s standards provide validated frameworks to define, include, and measure populations consistently — across therapeutic areas, geographies, and institutional settings. This methodology was first proven through SOGI data collection and the inclusion of people living with HIV in clinical research. It is designed to scale
Standards LIBRARY
Architecture & Governance 2 documents
How the Population Standards Program is structured, and the governance frameworks guiding how standards are developed, adopted, and maintained.
| SGMA-ARC-001 | Population Standards Architecture Forthcoming · Comment period opens soon | COMMENT |
| SGMA-GOV-PP-001 | Publications and Presentations Authorship Standards Forthcoming · Comment period opens soon | COMMENT |
Population Standards 3 documents
SGMA’s core standards. Validated frameworks defining how specific populations are identified, included, and measured across clinical research and healthcare.
| SGMA-STD-001 | SOGI Protocol Implementation Standards Open for structured commentary · Closes August 31, 2026 | COMMENT |
| SGMA-STD-HIV-001 | HIV Inclusion Protocol Standards Forthcoming · Comment period opens soon | COMMENT |
| SGMA-GOV-HIV-CV-001 | Cardiovascular DDI Governance Framework Forthcoming · Comment period opens soon | COMMENT |
Implementation 1 document
Adoption guidance, operational tools, and workflows for putting SGMA standards into practice at the site, sponsor, and institutional level.
| SGMA-IMP-STD | Sponsor Implementation Guide Forthcoming · Comment period opens soon | COMMENT |
Publications
Peer-reviewed work and flagship publications from SGMA’s research program.
View all publications →
How to comment
Every open standard can be reviewed and edited directly. Send your feedback as a tracked-changes Word file.
- Download the Word version of the standard you want to comment on, using the Download link on its row below.
- Turn on Track Changes for line edits. Use Word margin comments for broader points about scope or structure.
- Rename the file with your name and organization, for example SGMA-STD-001_LastName-(CompanyName).docx
- Email it to comments@sgma.global. Keep the standard’s ID in the subject line.
Comments may be used to revise the standards before publication.
A disciplined, six-stage development process.
SGMA standards are not position statements. They are methodological frameworks produced through a disciplined development process — the same rigor applied by established standards bodies across regulatory and clinical research ecosystems.
01
Field Gap Identification
Systematic review of participation gaps and methodological blind spots.
02
Method Development
Evidence synthesis, protocol design, and framework architecture.
03
Expert Review & Consensus
Multi-stakeholder review by clinical researchers, biostatisticians, sponsors, and regulators.
04
Standards Publication
Peer-reviewed publication and open-access release under CC BY 4.0.
05
Implementation Guidance
Adoption guides, training modules, protocol aids, and benchmark tools.
06
Continuous Update
Iterative review as science advances and adoption data informs refinement.
STANDARDS FAQs
Q: What are population standards?
Population standards are validated frameworks that define which populations are included in clinical research and healthcare — and how they are identified, characterized, and measured across systems. They provide the operational infrastructure to ensure population data is consistent, complete, and comparable.
Q: How are SGMA standards developed?:
Through a six-stage process: field gap identification, method development, expert review and consensus, standards publication, implementation guidance, and continuous update. All standards undergo structured commentary before publication.
Q: What does Under Structured Commentary mean?:
A formal review period where institutional stakeholders, advisors, and experts review drafts and provide feedback. Comparable to a public comment period in regulatory standards development. Documents may be revised based on feedback.
Q: How do I cite SGMA standards?:
Reference the document ID, full title, version, and publication date. For standards under commentary: [Document ID], [Title], SGMA, [Year], Under Structured Commentary. Formal citation guidelines published with each final standard.”
Q: What license are SGMA standards published under
Creative Commons Attribution 4.0 (CC BY 4.0) — free to download, adapt, share, and implement. Attribution to SGMA required.
Q: Are SGMA's standards about who gets included in trials, or how trial participants are characterized?
SGMA’s standards do not set representation requirements or enrollment quotas — that is regulatory territory. SGMA defines how populations are classified and operationalized across clinical research and healthcare: how they are identified across protocols and care settings, how they are consistently represented in studies, registries, and surveillance systems, and how that consistency is governed across global research and healthcare ecosystems. The goal is methodological consistency, not numerical targets.
Q: How are SGMA standards different from data standards?
Data standards define the format of clinical data — the structure of how information is recorded and exchanged. SGMA’s population standards address the classification and operational layer: how populations are defined and identified across protocols, eligibility logic, pharmacovigilance frameworks, and care delivery, and how that classification is governed consistently across global clinical research and healthcare systems. SGMA’s classification work is measure-agnostic — it can be applied to any validated SOGI instrument.
Q: What does it mean to implement a population standard?
Implementation means a sponsor, CRO, healthcare institution, or research network has integrated the standard into their operational infrastructure — protocol templates, eligibility criteria, case report forms, EMR phenotyping, safety monitoring, and analysis plans — in a way that produces consistent, auditable population data across studies, sites, and care settings.
Q: How do I participate in structured commentary?
Contact standards@sgma.global. Open to sponsors, CROs, regulatory professionals, academic researchers, and healthcare institutions.
