This document summarizes an online meeting about resources available from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to support researchers in implementing the new 2023 NIH data management and sharing policy. It discusses the NIDDK Central Repository, which acquires, maintains and distributes data and biospecimens from NIDDK-funded clinical studies. Eligibility and requirements for submitting resources to the repository are also covered.

1. An NIDDK Resource dknet.org
dkNET Office Hours
Are You Ready for 2023?
New NIH Data Management and Sharing Mandates
Dr. Jeffrey Grethe, dkNET Co-PI
Dr. Rebecca Rodriquez, Repository Program Director, NIDDK
Ms. Reaya Reuss, Chief of Staff to the Deputy Director, NIDDK
The support team members, NIDDK Central Repository
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dkNET Services
• Support Rigor & Reproducibility
• Discover useful research resources
• Explore the Hypothesis Center
• Make your data FAIR and more

2. An NIDDK Resource dknet.org
Are you ready for 2023?
dkNET Office Hours: New Data Mandates
Jeffrey S. Grethe
PI, NIDDK Information Network
Co-Director, FAIR Data Informatics Laboratory, UCSD

3. An NIDDK Resource dknet.org

4. An NIDDK Resource dknet.org
Having trouble? Ask dkNET

5. An NIDDK Resource dknet.org
dkNET Collection of Information

6. dknet.org
An NIDDK Resource
Where Can I Deposit My Data?
• List of DK relevant
repositories,
recommended by NLM
and various journals
• Created in conjunction
with NIDDK
• Coming soon: FAIR data
wizard
● FAIR Standards
● Clinical Repositories
Information
● Data maintenance
● Data size limit and cost
● Dynamic database

7. dkNET Office Hour- March 3, 2023
NIDDK Resources to Support Implementation of the
2023 NIH DMS Policy

8. Policy Requirements
2023 NIH DMS Policy
Submission of Data Management &
Sharing Plan with all applications for
funding beginning January 25, 2023
Compliance with the DMS plan
approved by the funding NIH Institute,
Center, or Office

9. NIH Sharing Website (sharing.nih.gov)
2023 NIH Resources

10. https://www.niddk.nih.gov/research-funding/research-resources
NIDDK Website

11. https://www.niddk.nih.gov/research-funding/research-resources/data-management-sharing
• Walk through of stages for
developing a DMS Plan
• NIDDK-specific guidance for each
DMS element
• Aides for Repository Selection
• Example DMS Plans
• Data and Metadata Standards
• Glossary of DMS terms
• FAQ
Guidance & Tools/Resources

12. Considerations for Selecting a Repository
• Intended to assist researchers in selecting an appropriate data repository with
desired characteristics (NOT-OD-21-016) to deposit their data and maximize
sharing
• Domain-specific, data type-specific, institution/community based, and generalist
repositories

13. dkNET Office Hour- March 3, 2023
NIDDK Central Repository
Submitting Resources to the

14. Planning Phase
/
NIDDK Data Sharing Ecosystem
Additional resources
Central Repository
NIDDK
Genomics
Proteomics
Clinical
Metadata
Biological
Imaging

15. NIDDK Central Repository
• Rapidly growing number of collections
– Impressive number of collections available to the external community
– Equal impressive number of investigators accessing resources
• Centralized biospecimen inventory
– Vial level visibility
– Rich and comprehensive biospecimen metadata
• Streamlining to reduce (real | perceived) barriers to access
– Improving metrics to better monitor progress and compliance
Embracing flexibility to continue to support NIDDK’s evolving mission

16. • Established to expand the usefulness of extramurally NIDDK-funded
multi-center clinical studies’ generated resources by providing access
to a wider research community beyond the end of the study
• Support receipt and distribution of data and biospecimens in a manner
that is ethical, equitable, and efficient
• Enable investigators not involved with the original work to test new
hypotheses without the need to collect new data and biospecimens
14GB
Clinical Data
437GB
Imaging Data
15.6M
Biospecimens
175
Available Studies
1230*
Requests
122*
Public Releases
*2018-2022
NIDDK Central Repository

17. Services
• Assist during project planning stages
before data are collected
• Acquire, curate, maintain, and
distribute resources from NIDDK-
funded clinical studies
• Resources for Research (R4R)
platform to submit and access NIDDK-
CR resources
Features
• Domain-specific
• Sustainable support model
• Controlled-access cloud-based
environment
• Well characterized and expertly curated
data available in common formats
• Data package version control and
Unique Persistent Identifiers (DataCite
DOI)
11
NIDDK Central Repository

18. NIDDK Central Repository
1. NIDDK extramurally supported clinical studies with significant NIDDK
programmatic involvement
– Including but not limited to clinical trials, prevention and control trials, and epidemiological studies
2. Other NIDDK supported clinical studies
– Including but not limited to ancillary studies to NIDDK supported studies eligible to deposit
3. Secondary research resulting from the use of resources
4. Non-NIDDK funded clinical studies within NIDDK research mission of
significant benefit to the scientific community
Submitting Resources: Who is eligible? Per NIDDK Sharing Policy (2013)

19. NIDDK Central Repository
• Data and biospecimen sharing plans must be approved before first
participant enrolled
• Informed consent language must address future research use
• Expected to deposit all data/metadata and a representative specimen
archival set (as applicable)
• Submit data in Limited Data Set format via secure file transfer
• Provide required study documentation (e.g., protocol/MOP, codebook/data
dictionary, data collection instruments/CRFs) and supplemental
documentation (e.g., list of publications, SAS programs/formats)
Visit: https://repository.niddk.nih.gov/pages/archive_requirements/
Submitting Resources: Requirements Per NIDDK Sharing Policy (2013)

20. NIDDK Central Repository
Supporting non-eligible studies fulfill DMS Policy requirements
• NIDDK-CR supports federated data sharing for other repositories and resources
• Encourage use of Common Data Elements (CDEs), clinical standards, ontologies,
and terminologies to facilitate interoperability of datasets in other repositories
• Federated studies in NIDDK-CR have dedicated study pages containing study
metadata and attributes, study information, and study documentation
– Provide links for access to resources external to NIDDK-CR
– Requestors must follow the source repository’s policies and procedures to
access data stored outside of NIDDK-CR

21. THANK YOU
For Repository Program Administrative enquiries, email us at
NIDDK-CRadmin@niddk.nih.gov
For information on assigning permanent identifiers for your
NIDDK-funded research outputs contact us at
NIDDKDataCite@niddk.nih.gov
For more information on services and support visit our website at
https://repository.niddk.nih.gov or email us at
NIDDK-CRsupport@niddk.nih.gov
For NIDDK DMS Policy information, visit
https://www.niddk.nih.gov/research-funding/research-
resources/data-management-sharing and NIDDK Information
Network (dkNET) https://dknet.org/rin/research-data-
management

22. Repository Sharing Policy and Practices
Policy Purpose:
• Balance the interests of the study investigators with those of the larger
scientific community
• Defines proprietary periods to maximize contributions and decrease
duplicative efforts
• Increase impact and scientific value
Sharing timelines encourage timely analyses by study investigators, and increases likelihood
of secondary research while resources are still relevant