• Patient identifiers (subject number): (*) Replaced by a new patient ID, consistently across all datasets to keep the patient-record relationship.
• Further unique identifiers: (*) Removal of identifiers such as kit numbers and devices.
• Site ID: (*) Removed.
• Date of birth: (*) Suppressed or generalized if age does not exist in the data.
• Age: Generalized.
• Country: may be suppressed entirely or selectively, or generalized into region.
• Dates/Times related to study subject: Date shifted with a random and individual offset same factor for all dates of a patient; however, different factor per patient (so called PhUSE shifted). Time remains unchanged.
• Comments, free text, variables containing personally identifiable information (PII), e.g., names, initials: Suppressed.
• Verbatim term of adverse events and medical history: Verbatim term replaced by coded dictionary terms.
• Verbatim term of concomitant medications: Verbatim term replaced by coded dictionary terms.

The following studies are eligible for data sharing:

1. Phase 2 and Phase 3 studies that are part of the submission package for a new medicine or new indication for regulatory approval of a previously approved medicine as of January 1, 2014, by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) (or is approved by one of these agencies if submitted to only one agency).
2. For Phase 2 and Phase 3 studies approved in the EU and US prior to 2014, and all phase 4 studies, research proposals requesting data from Novartis will be reviewed on an individual basis and data provided if materially possible (it may not be possible to provide data from studies that are more than ten years old).

The requested clinical studies should be for the approved indication and must have already been published.

For studies in which clinical data were collected subject to legal, contractual or consent provisions that prohibit transfer to third parties, data access may be precluded.

Novartis will not share data when there is a reasonable likelihood that individual patients could be re-identified, for example, in clinical studies of very rare diseases, single center studies, or studies with a very small number of patients.

Novartis will not share case narratives, documentation for adjudication, imaging data (e.g., x-rays, MRI scans, etc.), genetic data and exploratory biomarker data.

It is Novartis Policy not to share data from interim trial results, even if a Health Authority approval has been granted based only on interim trial data. Novartis will share data when the trial CSR is completed, and the results are published.

Studies supporting device registration or generic registration are not currently part of this data sharing commitment.

Access to data is determined by the Independent Review Panel based on the scientific merit of the research proposal.

In exceptional circumstances, access to data may be declined by the sponsor, for example, where there is a potential conflict of interest or an actual or potential competitive risk.

Raw dataset: This is the dataset collected for each patient in the clinical trial.

Analysis-ready dataset: This is the dataset Novartis used for analysis.

Protocol with any amendments: This describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial. The protocol is part of the appendices of the clinical study report.

Annotated case report form: This is a blank case report form with descriptions of the data collected and how they are described in the dataset.

Reporting and analysis plan: This describes methods of analysis, procedures for data handling and data displays (tables, listings and figures) Novartis used for the trial.

Dataset specifications: This is the meta-data that describes the datasets, e.g., variable labels and descriptions, code lists, formats.

Clinical study report: This is the report of efficacy data and safety data from the study. It forms the basis of submissions to regulatory authorities. Appendices that include patient-level data are not included, since these data are provided in the anonymized datasets. To protect research participants’ privacy and confidentiality, personally identifiable information will be redacted.

Redactions to this document will also be made to protect Novartis and study personnel personal data, and to protect Novartis’s commercially confidential information, including intellectual property rights.

Anonymization Reports: Data Anonymization Summary Reports will be provided for trial raw and analysis data sets anonymized after September 29, 2023. The reports summarize whether the data variable has been processed and details the outcome of the process.