Value through Innovation27 July 2016

Boehringer Ingelheim provides redacted clinical study reports (incl. appendices, but without line listings) and related clinical documents on request, under the following conditions. Boehringer Ingelheim also provides bona fide, qualified scientific and medical researchers access to de-identified, analysable patient-level clinical study data, together with documentation describing the structure and content of the datasets, also under the following conditions.

1. Access is provided after regulatory review has been completed or after termination of the development program and once the primary manuscript describing the results has been accepted for publication.

2. In some cases, contractual obligations vis-à-vis third parties or other restrictions (e.g., copyright issues) may not allow sharing documents or data. In rare instances, Boehringer Ingelheim may also have to decline requests that would require excessive resources to provide documents or data compared to their scientific or medical importance. For requests that already have been answered by available clinical documents or are part of the Boehringer Ingelheim publication plan, we will provide the requestor available documents and prioritize related publications. Required redactions and de-identification of data may, in rare cases, have the effect that the scientific value of the documents and data will be reduced. Furthermore, the limitations of the informed consent of study participants might not allow data sharing. In such cases, Boehringer Ingelheim will try to address requests by providing summary data or otherwise.

3. Boehringer Ingelheim does not provide data and reports for pharmaceutical formulation studies and associated analytical methods, and for studies pertinent to pharmacokinetics using human biomaterials, since there is a general understanding that the reports and data for such studies primarily contain commercially confidential information (CCI) and intellectual property (IP).

4. These commitments apply to all documents and patient-level study data of clinical studies initiated after January 1st, 1998.

Prior to providing access, documents and data are being examined, and, if required, redacted, and de-identified to protect personal data of study participants, study personnel, and Boehringer Ingelheim employees, to respect the boundaries of the informed consent of study participants, and to protect Boehringer Ingelheim’s commercial confidential information, including intellectual property rights.

Please submit your request for Clinical Study Reports and Related Clinical Documents Here. Please note that your request will be governed by a Document Sharing Agreement.