Our Members

Johnson & Johnson

About	We believe transparency of clinical trial data advances science and medicine and is in the best interest of the people who use our pharmaceutical, medical device, and consumer products, as well as healthcare providers. As such, we support the overall principles of greater clinical trial data transparency, including registration and disclosure of clinical trial results in external registries, publication of results in peer-reviewed journals, and sharing of clinical study reports (CSRs) and de-identified participant-level data from clinical trials.
How we share on the Vivli Platform	We utilize our established process with the Yale University Open Data Access (YODA) Project to review all research requests for clinical trial data from the Johnson & Johnson Family of Companies via the Vivli platform. Upon review, it may be determined that a research request is able to be fulfilled solely on the YODA Project platform and does not require sharing through Vivli. In that case, the data will be shared using the secure data environment provided by Johnson & Johnson. We appreciate and acknowledge that study participants (patients, investigators, and sites) who agree to participate in our clinical trials are members of the community of stakeholders who are involved in advancing medical knowledge. We are dedicated to protecting the commitments we have made with them, including patient privacy. The YODA Project serves as the independent review panel for evaluation of external requests by investigators and physicians for CSRs and de-identified participant-level data from our pharmaceutical, medical devices and consumer products sectors for scientific research that will advance medical knowledge and public health. For more information on this process or to make a request, please visit the YODA Project (http://yoda.yale.edu).
Studies listed for sharing	Available studies are listed on the YODA Project portal: https://yoda.yale.edu/jj-available-data as well as Vivli. Pharmaceutical Data Researchers may submit requests for full CSRs and/or de-identified participant-level data for pharmaceutical Phase II-IV clinical trials for which: The Janssen Pharmaceutical Companies of Johnson & Johnson is the market authorization holder; The product and relevant indication studied have been approved by regulators in the US and EU; and The study has been completed for 18 months. Medical Device Data Researchers may submit requests for full CSRs and/or de-identified participant-level data for “applicable” (as defined under FDAAA) medical device trials for which: A member company of the Johnson & Johnson Medical Devices Companies is the market authorization holder; The product and relevant indication studied have been approved by regulators in the US and EU in 2014 or later; The study was initiated in 2007 or later; and The study has been completed for 18 months.
Exceptions	Clinical trial data may not be provided in certain situations, including but not limited to: The privacy and confidentiality of research participant data cannot be protected (data cannot be fully anonymized in such a way as to guarantee the anonymity of the research participants); Studies of rare diseases may have too few participants to prevent their de-identification; The clinical trial informed consent does not allow the sharing of anonymized data; Where regulatory, legal, contractual, or other limitations exist; Limitations in data format and cannot be properly converted to electronic format; or Study data/documentation is not in English. The full policy is listed here Policies and Procedures
When Studies are available for sharing	See section on studies listed for sharing.
Additional Conditions for Access	Please refer to information on http://yoda.yale.edu.
What information will be provided	If available, the following anonymized/redacted participant-level data and documents will be provided for each clinical study: Individual Patient Data (raw/SDTM dataset)-This is the data collected for each patient in the clinical trial Annotated Case Report Forms (CRFs)-This is a blank case report form with descriptions of the data collected and how they are described in the dataset Dataset Specifications /Anonymization Report-This is the meta-data which describes the datasets (e.g., variable labels, variable descriptions, code lists, formats) Statistical Analysis Plan-This describes statistical analysis plans that include methods of analysis, procedures for data handling, and data displays (figures and tables) that were used for the trial Protocol-This describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial and information about all amendments Clinical Study Report-This is the report of efficacy and safety data from the trial. It forms the basis of submissions to regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
Questions or enquiries	Researchers can submit an inquiry if they don’t see a trial listed in which they are interested. Inquiry page: https://yoda.yale.edu/submit-inquiry
Review Criteria for Data Requests	The YODA Project will review proposals to ensure that the proposal has scientific merit, in that: the scientific purpose is clearly described; the data requested will be used to create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health; and the proposed research can be reasonably addressed using the requested data. Scientific review by peer experts and/or members of the YODA Project Steering Committee may be solicited if the YODA Project is unable to verify the scientific merit of the proposal. Please see the complete details regarding the YODA Project review process at this link: https://yoda.yale.edu/policies-procedures-guide-external-investigator-access-clinical-trial-data
Data Request Review Process	All requests for access to clinical trial data must proceed via the YODA Project process available at http://yoda.yale.edu
Access to study documents without participant-level data	Access to study documents without participant-level data may be provided (after the approval of the scientific proposal and completion of the Data Use Agreement).
Anonymization Standards	All data will be anonymized to protect the privacy of the individuals who participated in studies conducted by the Johnson & Johnson Family of Companies, in accordance with applicable laws and regulations and in compliance with the International Conference on Harmonization and Good Clinical Practice (ICH/GCP). In particular, clinical data anonymization follows the PHUSE De-identification Standard for SDTM 3.2.

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