MDR Data Sources

Introduction

This page lists the data sources used by the MDR and provides a very brief descriptive paragraph about each, as well as a link to the source's web site. In a few cases it also links to more detailed information about the data processing associated with a source. The main purpose of the page, however, is to list the published terms and conditions of use of each source and indicate how the MDR believes itself to be in compliance with them.

WHO

The mission of the WHO International Clinical Trials Registry Platform (WHO ICTRP) [1] is to ensure that a complete view of research is accessible to all those involved in health care decision making.
It does this by collecting and aggregating clinical trial registry records from all major registries, globally, and then making them all accessible through a single web portal. This ICTRP Search Portal therefore provides a searchable database containing the trial registration data sets made available by data providers around the world meeting criteria for content and quality control. There are currently 18 such providers.

Terms and conditions of use

The terms and conditions of data use are provided at https://www.who.int/ictrp/search/download/en/. The statements are listed below, together with a comment indicating the compliance, where necessary, of the ECRIN MDR.

1) "WHO ICTRP Database: The World Health Organization, through its International Clinical Trials Registry Platform, has developed the ICTRP database to provide patients, family members and members of the public current information about clinical research studies. The ICTRP database contains information about clinical trials being conducted throughout the world. This data is provided to the ICTRP by registries conforming to WHO standards. ICTRP is updated weekly. Trial data posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the data in the ICTRP database. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record."
Please note that ECRIN makes a similar disclaimer for all data displayed in the MDR.

2) "Availability: ICTRP data are publicly available to all requesters, at no charge."
The data is available on the web site (though in 04/20 the web site is not operating because of the demand caused by the COVID-19 pandemic), as XML files and as CSV files. The latter are freely available for download on the WHO ICTRP web site.

3) "Neither the WHO ICTRP, nor any of its data providers, make any warranties, expressed or implied, with respect to data contained in the database, and, furthermore, assume no liability for any party's use, or the results of such use, of any part of the database;"
Please note that, as in 1) above, ECRIN makes a similar disclaimer for all data displayed in the MDR.

4) "In any publication or distribution of these data (1) you should, to the extent possible and appropriate, attribute the source of the data as WHO ICTRP; (2) you should update the data such that they are current at all times; (3) you should clearly display the date the data were processed by WHO ICTRP;"
Please note that the intention is to provide a 'pop-up' over displayed data with provenance information, including source and date of data capture. This is planned for version 1.0 of the MDR.

5) "You shall not assert any proprietary rights to any portion of the ICTRP database."
We do not.

6) "You shall not use information extracted from the ICTRP database for marketing, promotional or commercial purposes."
We do not.

7) "You shall not use the name or emblem of WHO in association with the use of data from the ICTRP database."
We do not.

BioLINCC

The National Heart, Lung and Blood Institute (NHLBI) [2] is the coming together of two entities: the NHLBI Biologic Specimen Repository (NHLBI Biorepository), managed by the NHLBI, Division of Blood Diseases and Resources (DBDR), Transfusion Medicine and Cellular Therapeutics Branch, and the NHLBI Data Repository, managed by the NHLBI, Division of Cardiovascular Sciences (DCVS), Epidemiology Branch. These two programs have always had a similar mission, namely to enhance and facilitate further research in cardiovascular, pulmonary and hematologic conditions by providing access to qualified investigators to stored biospecimen and data collections.

Terms and conditions of use

Terms & conditions are summarised under Trademark, Branding, and Logo (see: https://www.nhlbi.nih.gov/about/contact/trademark-branding-and-logo). This states that:

1) "Most of the information on the NHLBI website is in the public domain and can be used without restriction. The NHLBI asks only that no changes be made to the publications, videos, images, or other formatted multimedia products and that the material, as well any NHLBI webpage links, not be used in any direct or indirect product endorsement or advertising. Although organizations may add their own logos to published NHLBI materials, organizations may not use the NHLBI logo on other print or digital materials without the Institute’s permission. (...)
Please use the following language to cite the source of the materials: Source: National Heart, Lung, and Blood Institute; National Institutes of Health; U.S. Department of Health and Human Services."
In compliance with this, the ECRIN MDR makes no changes to the data nor is involved in any 'direct or indirect product endorsement or advertising'. We do not include the NHLBI logo. Please note it is also the intention is to provide a 'pop-up' over displayed data with provenance information, including source and date of data capture. This is planned for version 1.0 of the MDR.

2) The same web page also states that:
"Unless noted otherwise, information posted on the NHLBI website within the nhlbi.nih.gov domain is considered to be in the public domain. You may link to the NHLBI website from your website without permission.
Other organizations are free to establish links to NHLBI online resources. When establishing links to the Institute’s website, you may not position or create the possible impression that the NHLBI is endorsing or promoting any particular organization, material, product, service, content, or information."
In compliance with this, the ECRIN MDR provides only simple links back to the relevant NHLBI page and adds no further comment or information, other than the provenance data to be added, as described above.

Yoda

The Yale University Open Data Access (YODA) Project is an effort by a group of academically-based clinical researchers to facilitate access to participant-level clinical research data and/or comprehensive reports of clinical research, such as full Clinical Study Reports (CSRs), a level of detail not customarily found in journal publications, with the aim of promoting scientific research that may advance science or lead to improvements in individual and public health and healthcare delivery. The YODA Project is guided by the following core principles, which reflect the overall mission of the project to promote open science by:

• Promoting the sharing of clinical research data to advance science and improve public health and healthcare
• Promoting the responsible conduct of research
• Ensuring good stewardship of clinical research data
• Protecting the rights of research participants

The YODA Project is currently collaborating with the following Data Partners to facilitate access to their clinical trial program data: Johnson & Johnson, Medtronic, Inc., Queen Mary University of London, SI-BONE, Inc.
To participate, each Data Partner must transfer full jurisdiction over data access to the YODA Project.

Terms and conditions of use

The Yoda website does not seem to include any general 'terms and conditions' about the use of the data displayed on the web site, although it has very full material about applying for and using the data described on the web site.
To ensure compliance with data usage policies, the Yoda project team were contacted directly, to check that the web scraping procedures in action were acceptable to them. Confirmation was received that this was the case.