IPD Archives - Page 2 of 2

Webinars, Publications & Presentations about Data Sharing

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.
	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

FAQs

Please see below for frequently asked questions regarding Vivli, including the general features of the Vivli Platform. For more specific questions, including any questions regarding a specific data request, please review the Vivli resources section for more detailed guidance or contact Vivli User Support directly at support@vivli.org.

Getting started with the Vivli platform

What license do I need to use to participate in the Vivli platform?

No license is needed. All users sign a Data Use Agreement specifying terms for use and re-use of the data. The DUA is the product of extensive negotiation with the organizations that contribute data to Vivli, and as such, the agreement is non-negotiable. More than 85 institutions from 25 countries have already signed this agreement.

Does Vivli comply with the General Data Protection Regulation (GDPR)?

Yes, Vivli does comply with GDPR. Please see Vivli’s privacy policy.

What support do you offer users?

Vivli has a dedicated, responsive support team available to answer any questions and help you through the process of submitting or requesting data. At any time, you may contact the Vivli support team at support@vivli.org. We aim to reply within 1-2 business days. For additional information about Vivli support options, check out our blog post on the topic: How our team supports users on the Vivli platform.

My organization is interested in becoming a member. How do I do that?

We’re delighted you’re interested in becoming an institutional member of Vivli. Learn more information about how to become a member here.

You do not have to be a member to request data using the Vivli platform. You can also share the data from your clinical research. You find out more about that by going to How to share data.

How do I create an account and log in to the Vivli platform?

Logging into the Vivli platform is easy! Check out our quick start guide to help you through the process.

What are benefits of data sharing?

Funders are increasingly mandating data sharing. The Gates Foundation, Wellcome Trust and many others are requiring that Individual Patient-Level Data from research they fund is shared. In addition, the updated NIH Data Sharing Policy went into effect January 2023. For many funders, data sharing costs are an allowable research expense and maybe built into future grant proposals and billed to current grants.
Top journals such as the NEJM, BMJ, Lancet and other ICMJE journals require that the data sharing statement is made at the time of trial registration. Journals are publishing the data sharing statement at the time of publication.
Moral obligations (owe it to trial participants). We owe it to participants of clinical trials who have volunteered to take part in this research for their data to be leveraged to maximize scientific knowledge. Surveys show that most participants want their data to be shared if adequate safeguards are in place.
Increase citations. Sharing detailed clinical research data is associated with increased citation rate.

What is the Vivli platform and how is it unique?

Vivli is an independent non-profit organization launched in 2016. Vivli evolved from a project of The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) to enhance access to clinical trials data by promoting data sharing and transparency. In 2013, the MRCT Center and a diverse group of global stakeholders embarked on a mission to define, design, and launch an innovative platform solution for global clinical trial data sharing.

Vivli’s mission is to promote, coordinate, and facilitate clinical research data sharing through the creation and implementation of a sustainable global data-sharing enterprise. Vivli serves to meet the needs of researchers in all parts of the clinical research ecosystem. For those requesting data, Vivli provides managed access to data from completed clinical trials around the globe and facilitates the ability to integrate data from existing platforms and data repositories. For those seeking to contribute data, Vivli provides a secure, flexible, and user-friendly platform to facilitate sharing clinical trial data with the research community.

The Vivli platform provides access to anonymized individual participant-level data (IPD) or the raw data that is collected during a clinical trial. The clinical trials represented in Vivli are global and contributed by a diverse group of data contributors. By serving as a global trusted platform, Vivli increases the discoverability of available data in the wider research ecosystem, and increases the overall capacity worldwide for effective data sharing, aggregation, re-use, and novel analysis of valuable clinical research data to advance science and improve public health. The Vivli platform is a cloud-based platform that consists of a dynamic search engine, a data repository, and a secure research environment.

For more information about Vivli and the Vivli platform, please visit our About page.

What types of data are currently available through the Vivli platform?

Vivli features data from completed interventional studies in a number of therapeutic areas for which anonymized Individual Participant-level Data (IPD) are available as well as data from observational studies.

Requesting access to data

What kind of requests are accepted on the Vivli platform?

The purpose of the Vivli platform is to support research utilizing available clinical data leading to published analysis of a concrete scientific hypothesis. For more information about our members’ data sharing policies, please visit each member’s page on our website.

How do I access data available in the Vivli platform?

Users either can access the data by downloading it or have access to a remote desktop workspace in a secure virtual research environment. On the member’s page, a member will share if the data is available by download or within the research environment. Find out more about the secure research environment.

Once I’ve submitted a data request, how long will it be before my request is approved and I have access?

On average it takes a few months to access data in the Vivli platform, but the timeline will vary depending on the number of data contributors, the number of studies, and your availability to respond to comments. Learn more about the data request process here. Once the proposal is final, the Vivli member(s) will prepare the data for sharing and then upload data to the platform. Additionally, you may find it helpful to review our blog post: 10 tips and tricks for drafting a successful data request.

Can I access studies not listed on the Vivli platform?

To enquire about a study not listed on Vivli or to obtain additional information not included in a study listing, please submit an enquiry through the Vivli Platform. To submit an enquiry or request access to study data, you will need to create a Vivli Platform account. Additional information on how to get started is available in our guide to requesting studies on Vivli.

For more information on Vivli Members, please visit the Member Page. Some Members may require that enquiries be submitted via their own portals. Enquiries will be answered at the discretion of the Member. Please note that most members do not share studies where the primary completion date has not yet been reached.

Have a question and need to get in touch with the Vivli team? Contact us.

How do I submit a request to access a particular study?

More information about how to submit a request is available in our quick start guide as well as our how-to guide for requesting studies, found here in our How To Guides.

How much does it cost to request data on the Vivli platform?

Vivli is a non-profit entity supported by both data contributors and data requestors who contribute to the administrative costs of running the platform. Requesting data is free and available to everyone. Data requestors who request data that are accessed through the secure research environment are charged a nominal cost for use of the secure research environment after a specified period of time, learn more here about that cost.

How can I find studies on the Vivli platform?

The Vivli platform allows users to search through listed studies using three search methods:

PICO Search,
Keyword Search,
Quick Study Look-up

For more information, see Searching for Studies on our website.

Who can use the platform and request data?

The search feature is open to all users. To request data, a researcher or team must first create an account on Vivli and submit a research proposal. You do not have to be a member to request data using Vivli.

Please see our quick start guide on how to request data.

What tools and software does Vivli provide for data analysis?

As a Vivli user, you have access to a secure research environment, a virtual work-space within the Vivli platform, which contains a bevy of the most popular tools for statistical analysis and manuscript preparation, including SAS, STATA, R, Python, Jupyter, the Microsoft Office suite and a full set of tools and scripts (available on Secure Research Environment page linked above). If your preferred tools are not included in the standard set, the Vivli team may be able to add them for you subject to having the appropriate license and security requirements. Contact support@vivli.org for any questions related to the uploading of additional tools, data and scripts.

Sharing data on the Vivli platform

Can I embargo my data set?

You can upload your data on Vivli before it is shared with others. The study would be listed on Vivli’s platform and would make note of the date when the study data will be available. Researchers can still request the data and it will be shared when the embargo period has ended.

Can I delete data I contributed to the Vivli platform?

You may update your data or request that your data is deleted by contacting the Vivli team at support@vivli.org.

How long will Vivli store my research in the Vivli platform?

At a minimum, Vivli will make data available for researchers for 10 years, unless they are contractually unable to do so. On an ongoing basis, Vivli evaluates its data holdings with regard to maintaining access and reserves the right to discontinue the distribution of a data collections when deemed appropriate.
When materials are deaccessioned, the data are no longer publicly accessible at Vivli, although they may still be preserved in Vivli’s storage vault. Because digital files are assigned a persistent digital object identifier (DOI), the study description is still available to view, but is not searchable through Vivli. Web crawlers are instructed to ignore the descriptions (via the robots exclusion protocol).

For more information about Vivli’s policy, please contact Vivli at support@vivli.org

Does my data need to be related to a published article?

No, the data you share does not have to be published. However, the data must be affiliated with completed clinical research. We can meet publication requirements by sharing underlying data.

What is the maximum file size?

Vivli data contributors can share files up to 500 MB. Larger sizes of up to 100T can be accommodated. If your file is larger than 1T, please contact Vivli Support at support@vivli.org.

Does submission to the Vivli platform satisfy publisher requirements for availability of data?

Yes. The Vivli platform meets ICMJE requirements which includes many of the leading journals. This blog provides sample language for how answer the questions about data sharing as part of the journal requirements.

How do researchers discover my data in the Vivli platform?

All data sets are assigned a unique Digital Object Identifier (DOI), which helps make data sets easily discoverable and easy to trace when cited.

How is data reviewed or curated?

Vivli offers curation of the study metadata through a process overseen by Cochrane. It also has specialist vendors who can help with anonymization. If you need help with anonymization, contact our support team at support@vivli.org to discuss your options.

Is data shared on the Vivli platform public or private?

Vivli offers a secure platform for storing data. The list of studies available via Vivli’s platform is public, however, users must request access to the data for a specific research proposal, and all requests must be approved before access is granted. For more information, see Share Data.

How much does it cost to share my data on the Vivli platform?

Learn about the the fee breakdown for sharing your data here: Share Data

How do I share data on the Vivli platform?

Learn more and how to share data on the Vivli platform.

Our team is available to answer any questions you might have about the process (support@vivli.org).

Who can share data?

Any individual or group with clinical trial data who has permission to share that data can list studies for sharing on the Vivli platform. All data contributors must sign and conform to the Data Contributor Agreement. For more information, please contact us at support@vivli.org.

What kind of studies may data contributors share on Vivli?

Data contributors may share all completed trials, including phase I-IV interventional studies and observational studies. Additionally, Vivli accepts qualified studies from any investigator, whether funded or sponsored by industry, an academic institution, or non-profit organization.

Do I need to anonymize my data set prior to contribution to Vivli?

Yes, Vivli will only host anonymized data in its system. To assist in this process, Vivli partners with d-wise and Privacy Analytics, industry leaders in health data-sharing methods and technologies, data security and de-identification. Our partners offer anonymization services to individuals and organizations who wish to share clinical research data on the Vivli platform. For more information, contact support@vivli.org.

What are the specific standardization requirements and file formats for datasets contributed to Vivli?

Files contributed should be provided in a format that can be used by the standard statistical packages (SAS, STATA, Excel) used for analysis. Data sets are not required to be standardized; however, we highly recommend that data sets be made available in CDISC SDTM (Standard Data Tabulation Model) format to support the most efficient data aggregation, re-use, and sharing.

What decisions over data governance should I make prior to making a data contribution in Vivli?

See Share Data on our website.

News & Events

Tag: IPD