On November 9, 2026, the National Institutes of Health (NIH) Office of Research on Women’s Health (ORWH) issued notice NOT-OD-26-111, formally releasing a Request for Information (RFI) on developing standardized Menopause Common Data Elements (CDEs). The RFI solicits direct feedback from the biomedical research community, clinical trialists, biostatisticians, data stewards, healthcare professionals, and patient advocates through December 18, 2026. By establishing a harmonized repository of standard data definitions, clinical questions, and allowable response sets, the NIH aims to eliminate decades of fragmented data collection across midlife women’s health studies and improve cross-cohort interoperability.
Background and Drivers of Notice NOT-OD-26-111
Menopause and the perimenopausal transition represent critical physiological periods affecting cardiovascular risk, metabolic health, cognitive function, and bone density. Despite the universal nature of this life stage for half the population, biomedical research has long suffered from significant inconsistencies in how menopausal status, symptoms, and interventions are documented. Clinical trials, observational registries, and population-based epidemiological cohorts routinely deploy non-harmonized questionnaires, divergent diagnostic thresholds, and inconsistent terminology for vasomotor episodes and hormonal exposures.
This methodological fragmentation severely hinders cross-study pooling, meta-analyses, and secondary data reuse. Issued under the auspices of the NIH Office of Research on Women’s Health in coordination with multiple participating institutes and centers, notice NOT-OD-26-111 addresses these structural bottlenecks. The initiative aligns directly with broader federal commitments to expand women’s health research by creating formal, standardized tools that biomedical teams can deploy consistently in prospective studies and retrospective chart reviews.
Proposed Scope and Tiered Structure of Menopause CDEs
The NIH Common Data Elements initiative structures clinical data variables into standardized, machine-readable units hosted within the NIH CDE Repository managed by the National Library of Medicine. In NOT-OD-26-111, the agency invites expert perspectives on structuring menopause-related variables into three distinct operational tiers:
- Core CDEs: Universal, essential variables intended for collection across all studies enrolling midlife women, regardless of whether menopause is the primary outcome. These include standardized baseline metrics such as chronological age, self-reported menstrual history and cycle regularity, surgical history (including unilateral or bilateral oophorectomy and hysterectomy), last menstrual period timing, and current or past exposure to hormone replacement therapies.
- Supplemental CDEs: In-depth, domain-specific measures designed for studies focused explicitly on menopause pathophysiology or therapeutic interventions. Proposed domains encompass validated symptom severity scoring for vasomotor episodes (hot flashes and night sweats), sleep disruption scales, genitourinary syndrome of menopause (GSM), bone mineral density assessments, cardiovascular biomarkers, and standardized instruments for mood and cognitive changes.
- Exploratory CDEs: Emerging measures and novel modalities, including molecular omics profiling, continuous physiological monitoring through wearable sensors, neuroimaging paradigms, and comprehensive tracking of social determinants of health and environmental exposures.
The notice also explicitly requests feedback on capturing underrepresented clinical contexts. In particular, the agency is seeking standards to properly document premature ovarian insufficiency (POI), early menopause before age 45, and iatrogenic or medically induced menopause resulting from bilateral gonadectomy, pelvic radiation, or gonadotoxic cancer chemotherapy.
Implications for Study Design and NIH Data Sharing Compliance
The development of standardized Menopause CDEs directly alters how investigators design protocols, draft data dictionaries, and satisfy federal compliance requirements. Under the current NIH Data Management and Sharing (DMS) Policy, grant applicants must submit detailed plans demonstrating how prospective research data will adhere to the FAIR data principles of findability, accessibility, interoperability, and reusability.
Adopting officially endorsed CDEs satisfies one of the most rigorous expectations of the DMS Policy by embedding standardized controlled vocabularies and common variable representations at the point of data collection. When principal investigators structure case report forms (CRFs) around recognized CDEs, data harmonization between electronic data capture (EDC) systems like REDCap and hospital electronic health records (EHRs) becomes substantially more robust. Research teams deciding on repository ingestion and database architecture can consult established frameworks on how to choose a metadata schema for a dataset to map internal variable names to SNOMED CT, LOINC, and MedDRA standards.
Furthermore, standardized CDEs assist research offices in monitoring compliance with institutional NIH inclusion policies across the lifespan. As research groups determine protocol workflows, data stewards must also evaluate whether an observational registry or biomarker validation study crosses regulatory thresholds under the operational framework of what is a clinical trial under NIH definition, as interventional protocols face heightened prospective registration and result-reporting mandates.
Actionable Recommendations for Research Offices and Data Stewards
With public comments due on December 18, 2026, research administrators, clinical trial offices, and principal investigators should take proactive steps to evaluate their institutional readiness:
- Participate in the Public Comment Process: Institutional research offices should mobilize faculty in obstetrics and gynecology, cardiology, oncology, endocrinology, and epidemiology to review NOT-OD-26-111 and submit detailed responses regarding existing validated instruments and potential implementation hurdles.
- Balance Data Depth Against Participant Burden: Submissions should emphasize modular CRF designs that prevent excessive participant response fatigue while maintaining longitudinal validity in clinical trials and clinic-based cohorts.
- Audit Institutional Data Dictionaries: Informatics teams and data core facilities should audit current women’s health study templates in local REDCap instances to identify non-standard variables that will require prospective alignment when the NIH publishes the final CDE sets.
- Anticipate Future Funding Opportunity Requirements: Following the closure of the RFI and synthesis of community input, the NIH is expected to reference the finalized Menopause CDE collection in upcoming Notices of Funding Opportunity (NOFOs), making early familiarization a strategic advantage for grant applicants.
Responses to NOT-OD-26-111 must be submitted electronically through the designated NIH submission portal or official response email by December 18, 2026. Submissions are voluntary and will be reviewed by the ORWH to establish the definitive national collection.
Sources
- National Institutes of Health, Office of Research on Women’s Health. Notice of Request for Information (RFI): Developing Menopause Common Data Elements (NOT-OD-26-111). Released November 9, 2026. Checked 2026-11-14. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-26-111.html
- National Library of Medicine. NIH Common Data Elements (CDE) Repository. Checked 2026-11-14. https://cde.nlm.nih.gov
- National Institutes of Health. Final NIH Policy for Data Management and Sharing (NOT-OD-21-013). Checked 2026-11-14. https://sharing.nih.gov/data-management-and-sharing-policy
