Guidance for researchers on preparing a DMSP and sharing NIH-funded data
The NIH has updated its policies on data management and sharing (DMS). Effective January 25, 2023, the NIH DMS policy applies to most research funding by the NIH, and requires all applicants planning to generate scientific data to prepare a DMS Plan (DMSP) that describes how they will manage and share data. An effective DMSP requires thoughtful planning, preparation, and execution. We’ve compiled information and resources here to support every step of the process.
How to prepare a DMSP
The DMSP is a set of principles and guidelines that outline requirements for sharing data generated by NIH-funded research. It includes six major elements:
- A description of the data type
- Related tools, software, and/or code
- Common data standard that will be applied to the data
- Information about data preservation, access, and associated timelines
- Factors affecting access, distribution, or reuse of data
- Overview of how compliance with plans for management and sharing will be managed
The DMSP should also include information about direct costs required to support the activities outlined in the Plan.
Vivli has a step-by-step guide to understanding each of these elements and items to consider when developing a DMSP. We also have a customizable DMSP exemplary language available for download and adaptation, which includes sample text as well as guidance on preparing and submitting a budget as part of the DMSP.
Fill out the form below to access all the DMSP Guidance provided by Vivli.
How to choose the right repository to share your data
To enable the implementation of the updated DMS policy, NIH has supported the establishment of the Generalist Repository Ecosystem Initiative (GREI). GREI is a collaboration of seven established generalist repositories who are working together to develop consistent standards and processes to facilitate sharing and reuse of data from NIH-funded studies. As part of preparing a DMSP, researchers will have the opportunity to review repository options and choose the one that best aligns with their needs. Vivli is part of the GREI initiative. The Vivli platform is the only GREI repository that focuses on sharing completed clinical research data at the individual participant level. To assist in considering these options, NIH has prepared guidance on selecting a data repository.
Once your grant is approved – what next?
How to submit studies to Vivli for data sharing
If you’ve decided that Vivli is the right repository for your study data, great! We’ve developed a straightforward and efficient submission process, and we’ve got detailed guidance on how to submit your data and a checklist when you’re ready to begin the process to share your data.
| Resource | Description | |
| Vivli Study Submission Guide | How to submit studies for sharing via the Vivli platform | Download PDF |
| Study Submission Checklist | A checklist of all information needed for the submission of a study | Download |
Further questions?
Email Vivli at support@vivli.org and we will be delighted to assist you.
The NIH Data Management and Sharing (DMS) policy went into effect in January 2023 to promote the sharing of scientific data.
Please watch Vivli’s recent webinar and find out more about how Vivli can help you navigate the NIH Data Management and Sharing policy. Hear from academic staff on their experiences in supporting researchers with their Data Management and Sharing Plans (DMSP).
During this webinar, we:
- Provide an overview of Vivli, including what types of data should be shared in Vivli
- Discuss the benefits of using Vivli to meet the data sharing requirements of your NIH grant
- Review the steps to completing the NIH DMSP and budget justification
- Hear views from academic staff on their experiences supporting researchers to complete the new NIH DMSP
Speakers include:
- Anne Seymour, Johns Hopkins University
- Amy Nurnberger, Massachusetts Institute of Technology
- John Borghi, Stanford University
- Rebecca Li and Julie Wood, Vivli
Participants had the opportunity to ask questions. This webinar is most useful for current or prospective NIH grantees or those who support them.
Vivli aims to advance human health through clinical research data sharing. One of the key ways we support this is through the Vivli platform, which facilitates data sharing. Vivli platform metrics as of 28 Feb 2025. The metrics will be updated every two months.
These tables provide details of approved research proposals that have published or presented their results.
Vivli works with many partners and funders to further its vision to advance human health through clinical research data sharing, to respect and honor the contributions of clinical research participants.
An experienced independent consultant acts as the secretariat for the Independent Review Panel (IRP). Data contributors can choose to have an independent, neutral party oversee the review of requests by accessing the esteemed Independent Review Panel who will review research proposals based on their merit.
For more information, please review the Independent Review Panel Charter. Read more about the IRP members.
Vivli provides the following resources to assist users of the Vivli Platform:
Data Request Guidance and Support
| Resource | Description | |
| Vivli User Account Quick Start guide | How to join the Vivli platform as a user so that you can submit a request for study data. | Download PDF |
| Vivli How To – Sign up for a Vivli Account | Video detailing how to sign up for a Vivli platform account | Watch Video |
| Vivli How To – Requesting Studies | How to request studies through the Vivli platform. | Download PDF |
| Vivli Data Request Quick Start (Video) | A 3-minute video showing how to submit a data request. | Watch video |
| Vivli Platform demo – How to search, request, and analyze data on Vivli | A short video showing how to request data on Vivli | Watch video |
| Vivli Lay Summary Training Video | Hints and tips for completing your Vivli Lay Summary as part of your data request. | Watch video
Download PDF |
| Vivli Data Request Form Worksheet | Worksheet of information needed to complete a Vivli data request | Download |
| Vivli Data Request Form Tips and Tricks | Hints and tips for completing your Vivli Data Request Form. | Download PDF |
| Data Request Form Sample | Example of fully completed Data Request Form | Download PDF |
| Vivli Policies in Brief | Synopsis of key policies governing interactions between researchers and data contributors during the lifecycle of a research proposal. | Download PDF |
| Software and R Packages Available in the Research Environment | Analytical and other software available in the research environment | Download PDF |
| Vivli AI/ML Model Requirements | Vivli's AI/ML policy outlines strict requirements for model data anonymization and limits export to traditional machine learning models. | Download PDF |
Study Submission Guidance and Support
| Resource | Description | |
| Vivli User Account Quick Start guide | How to join the Vivli platform as a user so that you can submit your study. | Download PDF |
| Vivli How To – Sign up for a Vivli Account | Video detailing how to sign up for a Vivli platform account | Watch Video |
| Vivli Study Submission Guide | How to submit studies for sharing via the Vivli platform | Download PDF |
| Vivli How To – Study submission | Data sharing instructional video | Watch Video |
| Study Submission Checklist | A checklist of all information needed for the submission of a study | Download |
| ICMJE Data Sharing Requirements | How to use Vivli to meet ICMJE data sharing requirements | Download PDF |
NIH DMSP Guidance
Fill out the form below to access all the DMSP Guidance provided by Vivli.
Vivli aims to advance human health through clinical research data sharing. One of the key ways we support this is through the Vivli platform, which facilitates data sharing. Vivli platform metrics as of 28 Feb 2025. The metrics will be updated every two months.
VIVLI WEBINARS
View Vivli’s webinars at your convenience by clicking on the links below:
| Date | Webinar | Speakers |
| January 2025 | Navigating Clinical Trial Data Sharing Under the New Declaration of Helsinki: Practical Steps for Instituting an Ethical and Effective Program | Rebecca Li, Vivli
Julie Wood, Vivli |
| April 2024 | The Potential Impact of Recent U.S. Legal Developments on Data Sharing with China and Other Countries of Concern | Rebecca Li, Vivli
David Peloquin, Ropes & Gray |
| April 2023 | Recent Developments in Data Privacy Laws and their Impact on Data Sharing | Rebecca Li, Vivli
David Peloquin, Ropes & Gray
Katherine Wang, Ropes & Gray |
| February 2023 | Submitting Your NIH Data Management and Sharing Plan using Vivli | Anne Seymour, Johns Hopkins University
Amy Nurnberger, Massachusetts Institute of Technology
John Borghi, Stanford University
Rebecca Li and Julie Wood, Vivli
|
| November 2022 | Applying the SAFE Data Standard to Securely Share Clinical Trial Data | Luk Arbuckle, Chief Methodologist, Privacy Analytics (an IQVIA company)
Stephen Bamford, Head of Clinical Data Standards & Transparency, Janssen Research and Development
Aaron Mann, CEO, Clinical Research Data Sharing Alliance
Moderated by:
Marcia Levenstein, Senior Advisor, Vivli |
| October 2022 | Mind the Data Sharing Gap: Navigating sponsor policies and data protection methodologies | Luk Arbuckle, Chief Methodologist, Privacy Analytics (an IQVIA company)
Liz Roberts, Senior Director, Data Policy and Privacy Lead, UCB
Moderated by:
Aaron Mann, CRDSA CEO |
| June 2022 | How Vivli Promotes Discoverability of Partner Platforms and Repositories | Ishwar Chandramouliswaran, NIH
Dawei Lin, ImmPORT
Ida Sim, UCSF and Vivli |
| June 2021 | Sharing Academic Clinical Research Data | Ida Sim, UCSF and Vivli
Dan Ford, Johns Hopkins University
Susanna Naggie, Duke University
Kim Serpico, Harvard T.H. Chan School of Public Health
Ara Tahmassian, Harvard University |
| March 2021 | Clinical Trial Data Sharing and Machine Learning Research | Ida Sim, UCSF and Vivli
Abigail Gregor, Ropes & Gray
Daniel Freshman, Ropes & Gray |
| September 2020 | Synthetic Data: How to preserve privacy of participants when sharing clinical data | Patrick Cullinan, Bluebird Bio
Khaled El Emam, Replica Analytics
Michael Lesh, Syntegra |
| July 2020 | Accelerating Science in the Age of COVID-19: Three Key Data Initiatives | Rebecca Li, Vivli
Elizabeth L. Ogburn, Dr. Barbara Bierer, COVID Collaboration Platform
Janice Chang, Cara Rinaldi, TransCelerate BioPharma, Inc |
| April 2020 | Data Sharing and Data Anonymization: the Vivli-Privacy Analytics Partnership | Rebecca Li
Niamh McGuinness |
| February 2020 | Future Directions: Real World Data, Real World Evidence and Clinical Trials | Dr. Ida Sim
Marcia Levenstein
Dr. Gregory Pappas
Dr. Jack Mardekian |
| November 2019 | Credit for Data Sharing | Dr. Barbara Bierer,
Ms. Heather Pierce |
| October 2019 | Why Data Sharing and Data Standardization Matters | Mr. David Bobbitt MSc, MBA
Dr. Ida Sim, MD, PhD
Dr. Rebecca Li |
| May 2019 | Top five questions small and mid-size companies should ask before embarking on a data sharing program | Dr. Rebecca Li |
| March 2019 | Keys to Submitting a Quality Research Proposal to a Data Sharing Platform | Ms. Cynthia Holas,
Dr. Sonali Kochhar,
Dr. Georgina Humphreys,
Dr. Joe Ross,
Ms. Ginger Gamble, MPH.
|
| February 2019 | Informed Consent and Data Sharing | Dr. Barbara Bierer ,
Dr. Rebecca Li ,
Mr. David Peloquin,
Dr. Stephen Rosenfeld |
| January 2019 | How to Share and Request Data on Vivli | Dr. Ida Sim, MD, PhD |
| November 2018 | IPD Meta-Analysis Webinar | Dr. Sarah Nevitt |
PUBLICATIONS ABOUT DATA SHARING
 | Health Data Sharing Platforms: Serving Researchers through Provision of Access to High-Quality Data for Reuse
Rebecca Li, Nina Hill, Catherine D’Arcy, Amrutha Baskaran, Patricia Bradford, "Health Data Sharing Platforms: Serving Researchers through Provision of Access to High-Quality Data for Reuse", Health Data Science, vol. 2022, Article ID 9768384, 3 pages, 2022 |
 | COVID-19 interventional trials: Analysis of data sharing intentions during a time of pandemic
Kristina Larson, Ida Sim, Megan von Isenburg, Marcia Levenstein, Frank Rockhold, Stan Neumann, Catherine D'Arcy, Elizabeth Graham, David Zuckerman, Rebecca Li. COVID-19 interventional trials: Analysis of data sharing intentions during a time of pandemic. Contemporary Clinical Trials. 2022. |
| Sharing Health Data: The Why, the Will, and the Way Forward A Special Publication from the National Academy of Medicine
Whicher, D., M. Ahmed, S. Siddiqi, I. Adams, M. Zirkle, C. Grossmann, and K. L. Carman, Editors. 2021. Health Data Sharing to Support Better Outcomes: Building a Foundation of Stakeholder Trust. NAM Special Publication.Washington, DC: National Academy of Medicine.
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| New NonProfit Aims To Bring Data Transparency To Researchers |
 | Move clinical trial data sharing from an option to an imperative |
 | Timely access to trial data in the context of a pandemic: the time is now.
Li R, Wood J, Baskaran A, et al. Timely access to trial data in the context of a pandemic: the time is now. BMJ Open 2020; 10:e039326. doi: 10.1136/bmjopen-2020-039326 |
 | COVID-19 trials: declarations of data sharing intentions at trial registration and at publication
Li, R., von Isenburg, M., Levenstein, M. et al. COVID-19 trials: declarations of data sharing intentions at trial registration and at publication. Trials 22, 153 (2021). https://doi.org/10.1186/s13063-021-05104-z |
 | Data Sharing Goals for Nonprofit Funders of Clinical Trials
Coetzee T, Ball M, Boutin M, Bronson A, Dexter DT, English RA, Furlong P, Goodman AD, Grossman C, Hernandez AF, Hinners JE, Hudson L, Kennedy A, Marchisotto MJ, Myers E, Nowell WB, Nosek BA, Sherer T, Shore C, Sim I, Smolensky L, Williams C, Wood J, Terry SF, Matrisian L
Data Sharing Goals for Nonprofit Funders of Clinical Trials J Particip Med 2021;13(1):e23011 doi: 10.2196/23011 PMID: 33779573 |
PRESENTATIONS
| May 10-11, 2021 | "Considerations for Sponsors when using a Data Sharing Platform" and panel, "Balancing Sharing Results and Data Whilst Protecting Participants Data Privacy" at InformaConnect Clinical Data Disclosure, Transparency & Plain Language Summaries | Julie Wood
Rebecca Li, PhD |
| May 5, 2021 | "Data Sharing in a Time of Pandemic", a webinar with Front Line Genomics | Rebecca Li, PhD |
| April 12, 2021 | "Implementation of Data Sharing platforms and How Researchers are Utilizing these Platforms to Further their Research.", a webinar with the HRB-Trials Methodology Research Network | Rebecca Li, PhD |
| March 26, 2021 | "Acceleration of Research and Implications for Research Transparency." Center for Biomedical Research Transparency Summit Series | Ida Sim, MD, PhD |
| January 19, 2021 | "Data Sharing of Rare Disease Data – Challenges and Rewards." PHUSE Data Transparency Winter Meeting | Rebecca Li, PhD |
| December 11, 2020 | "Vivli: A Global Clinical Trials Data Sharing Platform." dkNET webinar | Ida Sim, MD, PhD |
| November 6, 2020 | "Responsible Data-Sharing to Improve Research Integrity." European Medical Writers Association 2020 Virtual Symposium | Julie Wood |
| October 16, 2020 | "Privacy Incoherence in Medicines: The Confluence of Corporate Trade Secret, Government Non-Transparency, and AI Mediated Erosion of Patient Privacy." Northeastern University's Center for Law, Innovation and Creativity Annual Conference | Rebecca Li, PhD |
| August 18, 2020 | "Platform Analytics Tools to Support Rare Disease Drug Development." FDA convening hosted by the Duke-Margolis Center for Health Policy | Rebecca Li, PhD |
| April 24, 2020 | "Sharing, Discovering and Citing COVID-19 Data and Code." National Library of Medicine (NLM) at the National Institutes of Health (NIH)
| Ida Sim, MD, PhD |
| February 11, 2020 | "Vivli Clinical Research Data Sharing: Share. Discover. Innovate." NIH Workshop on the Role of Generalist Repositories to Enhance Data Discoverability and Reuse, Bethesda MD
| Ida Sim, MD, PhD |
| October 25, 2019 | “Finding New Solutions to Problems and Concerns in Clinical Data Sharing – Outcomes from Datathon."DIA Future of Evidence Workshop | Rebecca Li, PhD |
| October 10, 2019 | "Clinical Trial Data Sharing and Reuse: A New Reality for Researchers." Clinical Data Interchange Standards Consortium Webinar | Ida Sim, MD, PhD
Rebecca Li, PhD |
| September 27 2019 | "Preparing for clinical trial data sharing and re-use: the new reality for researchers." NIH Collaboratory Grand Rounds | Rebecca Li, PhD
Frank Rockhold, PhD |
| September 19, 2019 | “The Vivli Experience in Sharing Clinical Trial Data Globally.”OHRP Exploratory Workshop: Privacy & Health Research in a Data-Driven World | Rebecca Li, PhD |
| June 2019 | “Symposium SY13: Data sharing and responsible conduct of research: sharing industry experiences as part of the research transparency environment."World Conference in Research Integrity, Hong Kong | Rebecca Li, PhD |
| March 27, 2019 | “Vivli: A Global Secure Data-Sharing Platform for Participant-Level Clinical Trial Data." Medical Informatics Association Summit, San Francisco CA | Ida Sim, MD, PhD |
| January 30, 2019 | “The Disclosure and Data Sharing Lifecycle.” CBI Clinical Data Disclosure and Transparency Conference, Philadelphia PA | Julie Wood
Thomas Wicks (TrialScope) |
| October 25, 2018 | "Sharing and Using Deidentified Individual Participant Data (IPD)." DIA Global Clinical Trials Transparency Conference, London | Rebecca Li, PhD |
| March 13, 2018 | “Vivli: A Global Secure Data Sharing Platform for Participant-level Clinical Trial Data.” American Medical Informatics Association Summit, San Francisco CA | Ida Sim, MD, PhD |
| November 17, 2017 | “Acceleration of Innovation to Overcome Intractable Diseases." Academic Research Organization’s 2nd Global Network Workshop, Austin TX | Ida Sim, MD, PhD |
