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.
Medical Device Data
|Exceptions||Clinical trial data may not be provided in certain situations, including but not limited to:
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:
|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:
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.|