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NIH Collaboratory
Living Textbook of
Pragmatic Clinical Trials

COVID-19 Resources

Access the latest information on COVID-19 for clinical researchers
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Rethinking Clinical Trials

A Living Textbook of Pragmatic Clinical Trials

  • Design
    • What is a Pragmatic Clinical Trial?
    • Decentralized Pragmatic Clinical Trials
    • Developing a Compelling Grant Application
    • Experimental Designs and Randomization Schemes
    • Endpoints and Outcomes
    • Analysis Plan
    • Using Electronic Health Record Data
    • Building Partnerships and Teams to Ensure a Successful Trial
    • Intervention Delivery and Complexity
    • Patient Engagement
  • Data, Tools & Conduct
    • Assessing Feasibility
    • Acquiring Real-World Data
    • Assessing Fitness-for-Use of Real-World Data
    • Study Startup
    • Participant Recruitment
    • Monitoring Intervention Fidelity and Adaptations
    • Patient-Reported Outcomes
    • Clinical Decision Support
    • Mobile Health
    • Electronic Health Records–Based Phenotyping
    • Navigating the Unknown
  • Dissemination & Implementation
    • Data Sharing and Embedded Research
    • Dissemination Approaches for Different Audiences
    • Implementation
    • End-of-Trial Decision-Making
  • Ethics & Regulatory
    • Privacy Considerations
    • Identifying Those Engaged in Research
    • Collateral Findings
    • Consent, Disclosure, and Non-Disclosure
    • Data and Safety Monitoring
    • Ethical Considerations of Data Sharing in Pragmatic Clinical Trials
    • Ethics for AI and ML
    • IRB Responsibilities and Procedures

Additional Resources

CHAPTER SECTIONS

Data Sharing and Embedded Research


Section 9


Additional Resources

Expand Contributors
Gregory E. Simon, MD, MPH
Gloria Coronado, PhD
Lynn L. DeBar, PhD, MPH
Laura M. Dember, MD
Beverly Green, MD, MPH
Susan S. Huang, MD, MPH
Jeffrey G. Jarvik, MD, MPH
Vincent Mor, PhD
Joakim Ramsberg, PhD
Edward J. Septimus, MD
Miguel A. Vazquez, MD
William M. Vollmer, PhD
Douglas Zatzick, MD
Adrian F. Hernandez, MD, MHS
Richard Platt, MD, MS

Contributing Editor
Karen Staman, MS

NIH Data Sharing Resources

National Institutes of Health (NIH) has services and platforms designed to help share, archive, and find products from research
  • Open NIH-supported domain-specific repositories that relate to a specific discipline
  • Other NIH-supported domain-specific resources, that have some limitations on depositing or accessing data
  • Generalist repositories including Dataverse, Dryad, Vivli, etc.

Grand Rounds

September 27, 2019 Preparing for Clinical Trial Data Sharing and Re-use: The New Reality for Researchers (Rebecca Li, PhD, Frank Rockhold, PhD)
September 28, 2018 Assessing and Reducing Risk of Re-identification When Sharing Sensitive Research Datasets (Greg Simon, MD, MPH, Deven McGraw, JD, MPH, Khaled El Emam, PhD)
July 13, 2018 Clinical Trial Data Sharing: Perspectives from Participants and PCORI (Michelle M. Mello, JD, PhD, Steven Goodman, MD, MHS, PhD)
September 28, 2017 Assessing and reducing risk of re-identification when sharing sensitive research datasets (Gregory Simon, MD)

Podcasts

October 1, 2019 Preparing for Clinical Trial Data Sharing and Re-use: The New Reality for Researchers (Rebecca Li, PhD, Frank Rockhold, PhD)
July 17, 2018 Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing (Michelle Mello, JD, PhD)

News

August 13, 2018 JAMA Commentary Highlights the Value of Data Enclaves and Distributed Data Networks

Previous Section Next Section

SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. Data Sharing Concerns
  3. Data Sharing Solutions for Embedded Research
  4. Patient Perspectives on Data Sharing
  5. Data-sharing Policy at the NIH, Collaboratory, and HEAL
  6. Incentive Structure and Citations for Data Sets
  7. Preparing for Data Sharing
  8. Moving Forward
  9. Additional Resources
  10. FAQ


Version History

April 4, 2021: Added Grand Rounds and information on NIH data sharing repositories (changes made by K. Staman).

Published December 17, 2018

current section :

Additional Resources

  1. Introduction
  2. Data Sharing Concerns
  3. Data Sharing Solutions for Embedded Research
  4. Patient Perspectives on Data Sharing
  5. Data-sharing Policy at the NIH, Collaboratory, and HEAL
  6. Incentive Structure and Citations for Data Sets
  7. Preparing for Data Sharing
  8. Moving Forward
  9. Additional Resources
  10. FAQ

Citation:

Data Sharing and Embedded Research: Additional Resources. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/dissemination/data-share-top/additional-resources/. Updated September 25, 2025. DOI: 10.28929/104.

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