How Vivli meets the NIH ‘Desirable Characteristics for Data Repositories’

The NIH policy for Data Management and Sharing (effective January 2023) includes the supplemental information Selecting a repository for data resulting from NIH-Supporting Research (NOT-OD-21-016), which outlines the data repository characteristics that researchers should seek out to share their NIH-funded research. Vivli meets all the Desirable Characteristics for Data Repositories, including the additional characteristics for storing human subjects data.

Vivli is a well-established repository for researchers to store their clinical research data from NIH-funded research and to cite in their NIH Data Management and Sharing Plans. The Vivli platform focuses on helping researchers securely archive, access and analyze individual participant-level data (IPD) from completed clinical research studies to serve the international research community. Vivli makes it easy to share data in a way that is citable and reusable while also protecting the privacy of participants involved in the clinical research. Vivli is listed on the National Library of Medicine’s Data Sharing resources list of Generalist repositories. Find out more about how Vivli meets the characteristics as set out by the NIH by toggling on the information about each characteristic below.

Persistent Identifiers

All clinical research that is available for search and request on the Vivli platform is assigned a DataCite Digital Object Identifier (DOI) at the time the metadata for the clinical research data appears in the Vivli search and is available for request. If the data or supporting documents are ever updated, this is chronicled and tracked and is noted in the version control within the persistent identifier. If a dataset is de-accessioned or no longer available, Vivli follows the Datacite best practice and sets up a landing page for that unique and persistent identifier so it is transparent that the dataset is no longer available. Data Contributors and Data Requests have the option to add their Orcid ID.

Sustainability

Vivli is a US-based non-profit, registered as a 501c3 entity in Massachusetts. Our mission is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the creation and implementation of a sustainable global data-sharing enterprise. To date, we have a global membership of more than 40 institutional members who have multi-year, long-term memberships with Vivli. Membership fees cover our operating costs. Additional funding also provides for Vivli to take part in specific projects through grants and contracts. See https://vivli.org/annualreport/ for a current breakdown of our funding.

Data Preservation and Retention

Vivli preserves the data for its useful lifetime, which we define as a minimum of 10 years, unless there is a different contractual lifespan. 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.

Metadata

To include clinical research studies on Vivli, the following minimal mandatory metadata needs to be included: Sponsor Name, Sponsor ID or clinicaltrials.gov identifier, study title, medicine, condition, phase (if applicable). If a clinicaltrials.gov identifier is provided, Vivli will use the clinicaltrials.gov API to include additional metadata that is already required for researchers when registering their studies.

The link between data and metadata is explicit by stating the globally unique and persistent identifier in the metadata that relates to the data. Vivli does this in Schema.org which is used to ensure indexing of Vivli content on Google, Google Scholar, and Google Dataset Search.

Data Quality and Metadata Curation

Vivli uses the metadata supplied by its data contributors to list information about the study on its platform. If possible, we use the information provided by each data contributor on Clinicaltrials.gov. The study registry has an API which Vivli can link to and receive automatic updates if any information on the study listing changes. If a study is not registered on clinicaltrials.gov, we ask the data contributor to provide this information. This metadata is supplied and proceeds through a curation process overseen by our partner, the Cochrane Collaboration. The accuracy and integrity of the data being provided is the responsibility of the data contributor due to the need for a data contributor to comply with global regulations, including privacy. Vivli does have specialist partners who can help data contributors meet those regulations.

Free and Easy Access

Access to metadata and data hosted by Vivli is free and accessible to all, subject to meeting a data contributor’s data sharing policies, which are publicly stated on our website.

Broad and Measured Reuse

Every two months Vivli’s metrics are updated including all approved proposals for its data as well as aggregated metrics for submitted proposals, approved, denials (by data contributor and by reason) as well all public disclosures that result from research proposals. In addition, Vivli has implemented the Counter Code of Practice (Make Data Count) to measure views and access at the study level.

Clear Use Guidance

Researchers and their institutions need to sign the Vivli Data Use Agreement. To date, more than 250 agreements have been signed with institutions from around the world. In addition, the Vivli team maintains a rich set of how-to guides. Vivli also has chat system on the platform as well as a support email address support@vivli.org to answer any questions by a researcher who wishes to contribute or request data. The Vivli team follows up and supports researchers through every stage of the process.

Security, Integrity and Confidentiality

Vivli is audited to the Soc 2, Type 2 audit standard which is the industry standard for the sharing of anonymized data from completed clinical trials. This audit standard covers all aspects of logical, physical and technical security policy and practice of an organization and includes questions about prevention of unauthorized access to, modification of, or release of data, with appropriate levels of security for anonymized individual-level participant-level data. It also covers documentation of administrative, technical and physical safeguards that are employed to comply with applicable confidentiality, risk management and continuous monitoring for sensitive data. This audit includes a yearly penetration test and disaster recovery test. Vivli has been audited to this standard for the past three years and has never had an audit exception.

Common Format

Vivli’s metadata follows the DataCite metadata schema and is supplemented by information from Clinicaltrials.gov. The metadata is available via Datacite as well on Google Dataset search following Schema.org for our metadata via JSON array where it can be saved and exported for further use.

Data held on the Vivli platform can be accessed via download or the secure research environment (an isolated, cloud-based remote desktop). Anonymized individual patient-level data (IPD) accessed via the secure research environment cannot be removed, but the analysis of the data can be requested for removal.

Vivli accepts all formats for data, but we have a preference for data in the SDTM format. See FAQs “What are the specific standardization requirements and file formats for datasets contributed to Vivli?” https://vivli.org/resources/faqs/

Provenance

All Vivli datasets and metadata have a full audit trail which records the metadata curation process, when the study was first listed in the Vivli search, when the data sets were requested, and by whom, and accessed, by whom, as part of a data request, and what version of the data was accessed.

How Vivli meets the Additional Considerations for Repositories Storing Human Data (even if de-identified)

Fidelity to Consent

Vivli data contributors ascertain upfront if the data they are providing has any restrictions to sharing based upon the participant consent language (such as for use only within a certain disease population or condition).

Restricted Use Complaint

Researchers and their institutions need to sign the Vivli Data Use Agreement. In addition, a user accessing the data in Vivli secure research environment must agree to Vivli’s terms of use policy.

Privacy and Plan for Breach

Vivli is audited to the Soc 2, Type 2 audit standard which is the industry standard for the sharing of anonymized data from completed clinical trials. This audit standard covers all aspects of logical, physical and technical security policy and practice of an organization. This audit includes a yearly penetration test and disaster recovery test. Vivli has been audited to this standard for the past three years and has never had an audit exception. This audit includes a review of our policy and procedures to protect human subjects’ data from inappropriate access and a review of our policy and procedures for detected data breaches.

Download Control

Every action taken on the Vivli platform is recorded in an audit trail on the platform. Every time data is accessed either via the secure research environment or downloaded the action is recorded in the platform. For those datasets that are designated as “accessible via download”, Vivli requires a researcher to confirm that they have destroyed the data and documents once they have completed their research. This requirement is included as a term in the Vivli Data Use Agreement.

Violations

Vivli has clear procedures of the violations of terms of use and data mismanagement on the platform Terms of Use agreement.

Request Review

Vivli has a clear and transparent process for reviewing requests. An overview is available here. https://vivli.org/resources/requestdata/ under section “Data request review process”.

Each data contributor outlines their review process on our website and in the metadata of the study. An Independent Review Panel can be selected to make the final, scientific decision about a request.

If you or your organization has clinical research data to share, please get in touch with us by filling out the form below and we will respond shortly.