Bayer commits to sharing upon request from qualified scientific and medical researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the United States (US) and European Union (EU) as necessary for conducting legitimate research.

For products that have not received market approval in either US or EU before Jan 01, 2014, data will be shared if they have been approved on or after Jan 01, 2014 by only one of the agencies, provided clinical trials are not part of an ongoing review or are going to be part of a planned submission to a highly regulated regulatory authority such as EMA or FDA.

Bayer may not be able to share data in case of substantial practical constraints to provide technical data access. For example, there may be issues related to the size of databases from genetic studies.

Where clinical data were collected subject to legal, contractual or consent provisions that prohibit transfer to third parties, or in case of substantial conflicts of interest, data access under this policy may be precluded.

For partnered compounds data access will be provided if the development partner agrees to data access and to related data sharing agreements with the requesting third party. Data Access can be provided when it has been technically implemented (planned by Dec 2014).

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 study.

Analysis-ready dataset. This is the dataset used for Bayer’s analysis.

Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical study.

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 Bayer used for the study.

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

Clinical study report. This is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices that contain no patient relevant data (e.g. audit certificates or manuals from providers of various diagnostic services) as well as individual patient level data (e.g. narratives) are not included. The data from narratives will of course be contained – in aggregated fashion – in the datasets provided by Bayer.

Documents will be redacted to protect personal data of study participants, study personnel, and Bayer employees, and to protect Bayer’s commercially confidential information, including intellectual property rights.