NIH Data Management and Sharing Policy
The policy requires applicable researchers to plan for management and sharing of scientific data and to comply with approved plans, subject to limitations and protections.
What the authority record establishes
The policy requires applicable researchers to plan for management and sharing of scientific data and to comply with approved plans, subject to limitations and protections.
Binding through applicable award terms and NIH policy
The exact official title, issuing body, jurisdiction, version or application record, and linked source define the scope of this page. Readers should not transfer the authority's status to a commercial product or infer transaction-, patient-, system-, site-, or organization-specific applicability from this summary.
Why it matters to this market
R&D platforms should make data identification, metadata, access, repository, retention, sharing, privacy, and stewardship responsibilities visible without implying that an ELN alone satisfies the plan.
Affected operating stages
- Planning
- Data Generation
- Documentation
- Storage
- Sharing
- Preservation
- Oversight
Capabilities to examine
ELN Experiment Authoring And Collaboration
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for ELN experiment authoring and collaboration.
Raw Scientific-File Capture And SDMS Archive
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for raw scientific-file capture and SDMS archive.
Scientific Data Models Ontology And Semantic Context
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for scientific data models ontology and semantic context.
Scientific Search Analytics And Data Reuse
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for scientific search analytics and data reuse.
Electronic Signatures Audit Trails And Record History
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for electronic signatures audit trails and record history.
Role Identity Access And Segregation-Of-Duties Controls
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for role identity access and segregation-of-duties controls.
API Integration And Enterprise Interoperability
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for API integration and enterprise interoperability.
Deployment Administration Change Control And Validation Support
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for deployment administration change control and validation support.
Affected buyer audiences
- research institutions
- principal investigators
- data stewards
- technology
- sponsored research
Implementation questions
- Which entities, products, populations, transactions, systems, sites, or jurisdictions are actually within scope?
- What is binding, what is guidance, and what is a technical or consensus standard?
- Which publication, adoption, effective, application, transition, and enforcement dates differ?
- Who owns legal, clinical, quality, regulatory, policy, or operational interpretation?
- How will a source revision affect open work and historical decisions?
Interpretation boundary
The policy does not select a product, determine what data should be shared in a specific study, or establish privacy, consent, scientific validity, or plan compliance.