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.

Consumer Data
Researchers may submit requests for full CSRs and/or de-identified participant-level data for interventional clinical studies in humans of consumer products that are regulated as medicinals or devices for which:

• A member company of Johnson & Johnson Consumer Inc. is the market authorization holder;
• The product and relevant indication studied have been initially authorized or cleared by the US FDA and EMA or by a health authority anywhere in the world if US FDA and EMA authorization or clearance are not required or sought to allow marketing in that region from 2014 going forward; and
• The study has been completed for 18 months.

• 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.

• 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)

1. the scientific purpose is clearly described;
2. the data requested will be used to create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health; and
3. the proposed research can be reasonably addressed using the requested data.