Cardiovascular DDI Governance Framework
Comment Period: until 30th October 2026
*This is a draft document and is not for implementation. Submit comments using the email id
Cardiovascular DDI Governance Framework, Vol. 1
Draft Version 1.0 · April 2026 · Draft for Public Comment
This framework provides a specialized cardiovascular DDI governance methodology to support systematic safety assessment for the inclusion of people living with HIV (PLHIV) in cardiovascular clinical trials. It is Volume 1 of the SGMA Therapeutic Area DDI Governance Framework Series, companion to the HIV Inclusion Protocol Standard (SGMA-STD-HIV-001).
This framework defines how interaction findings are translated into protocol eligibility decisions, monitoring requirements, and documentation. It provides the governance layer between pharmacokinetic interaction evidence and clinical trial protocol design — covering five cardiovascular sub-indications: hypertension, ASCVD, heart failure, stroke and anticoagulation, and pulmonary arterial hypertension (PAH).
Open for Comments until 30th October 2026
| Document | Cardiovascular DDI Governance Framework, Vol. 1 |
| Standard Code | SGMA-GOV-HIV-CV-001 |
| Document Type | Therapeutic Area DDI Governance Framework |
| Series | Therapeutic Area DDI Governance Framework Series |
| Volume | Volume 1 of a planned series |
| Therapeutic Area | Cardiovascular |
| Sub-Indications | Hypertension · ASCVD · Heart Failure · Stroke / Anticoagulation · PAH |
| Version | Draft Version 1.0 (2026) |
| Publication Date | April 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 |
| Companion Standard | SGMA-STD-HIV-001 · HIV Inclusion Protocol Standard |
| Related Standards | SGMA-ARC-001 · SGMA-STD-001 · SGMA-STD-HIV-001 · SGMA-GOV-PP-001 |
Cite This Document
SGMA. Cardiovascular DDI Governance Framework, Vol. 1. SGMA-GOV-HIV-CV-001. Draft Version 1.0, 2026. sgmastandards.org/cardiovascular-ddi-governance-framework
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