NIDDK Data Repository Requirements

In addition to NIH-wide requirements, and specific requirements of the Notice of Funding Opportunity (NOFO) and/or Notice of Award (NoA), NIDDK expects recipients to follow applicable Institute-specific expectations for management, preservation, and sharing of scientific data, metadata, software, code, and associated specimens.

Use of the NIDDK Central Repository

For studies designated by NIDDK, recipients will be required to submit data and/or specimens to the NIDDK Central Repository in accordance with study-specific guidance and timelines approved by NIDDK. The NIDDK Central Repository supports long-term preservation and sharing of clinical study data, specimens, and associated documentation for secondary research use.

Recipients using the NIDDK Central Repository are expected to:

• Work with the Repository and NIDDK program staff early in the award period to establish data submission plans and timelines;
• Follow Repository requirements for documentation, data formatting, de-identification, quality control, and transmission;
• Ensure that informed consent and institutional review board approvals are consistent with future data and specimen sharing; and
• Use Repository submission procedures, templates, and standards as specified by the NIDDK Central Repository.

Use of Appropriate Repositories

When a domain-specific repository is identified by NIH policy, NIDDK program requirements or the funding opportunity, recipients should use that repository. Recipients are strongly encouraged to register their selected repositories, tools, and shared datasets with dkNET to enhance discoverability within the NIDDK research community.

Recommended Data Standards and Resources

To maximize interoperability, NIDDK expects investigators to utilize established data and metadata standards appropriate to their specific research domain. For research falling under core NIDDK mission areas (diabetes, endocrinology, kidney disease), the following specific standards are highly recommended or expected:

• TEDDY (The Environmental Determinants of Diabetes in the Young): Clinical data formats and structures developed for diabetes research.
• iCoDE (Integrated Continuous Glucose Monitoring Data Exchange): Consensus data formats, terminology standards, and workflows designed to support interoperability and reuse of continuous glucose monitoring (CGM) data.

For human subjects research, investigators are strongly encouraged to utilize Global Unique Identifiers (GUIDs) to safely link participant data across multiple studies without exposing Personally Identifiable Information (PII) or Protected Health Information (PHI).

Specimen Sharing

• NIDDK requires designated investigators to prospectively plan to set aside an appropriate portion of all collected specimens for later submission to an NIDDK approved repository, ensuring that specimen sharing is planned from the outset and reflected in the study’s consortium governance and documentation.
• NIDDK expects that once NIH data sharing timelines are met, designated NIDDK-funded studies may not continue exclusive use of study generated specimens and must make them publicly available through an NIDDK-approved repository or another NIDDK-approved public source.
• Ancillary studies that use data or specimens from an NIDDK funded parent study must adhere to both NIH and NIDDK sharing policies and remain subject to the parent study’s governance structure, ensuring that all specimen use and sharing complies with NIDDK’s specific oversight requirements.