Sponsor Specific Details: Grünenthal

Clinical trials conducted in patients that had first clinical study protocol approval after 15 July 2014, in support of authorized treatments in the EU and US only (unless submission is planned for only one of the two regions) and for which Grünenthal is responsible for the data. The data of these trials includes anonymized individual patient-level data only.

Further, Grünenthal will share redacted clinical study reports for clinical trials conducted in patients in support of authorized treatments in the EU and the US (unless submission is planned for only one of the two regions), that had first clinical study report approval from 2003 onwards and for which Grünenthal is responsible for the data.

Access to the clinical data will not be given if the Grünenthal Data Sharing Request Review Board considers any of the following:

• There is a reasonable likelihood that individual patients could be re-identified.
• Access would violate the patients' informed consent.
• Access might jeopardize incentives for future investment in biomedical research.
• There are contractual or legal or consent provisions that prohibit transfer to third parties. Where this applies, summary information will be offered instead where possible.
• Provision of the requested data would cause unacceptable costs.

There is no appeal process for rejected research proposals.

Documents and data of investigator initiated trials (IIT) will not be shared.

For clinical trials performed as part of programs together with development partners, deviations from the data sharing processes may be implemented if the following requirements are met:

• These deviations do not result in non-compliance with legal/regulatory requirements or requirements arising from data privacy laws.
• These deviations do not result in non-compliance with the EFPIA Principles for Responsible Clinical Trial Data Sharing.
• Any deviations from Grünenthal processes are approved by the Grünenthal Data Sharing Request Review Board.
• Suitable process documentation is filed according to Grünenthal's standard operating procedures.

Data will be shared no earlier than 30 months (Phase I trials) or 12 months (Phase II-III trials) after trial completion (i.e., the timepoint of last subject out).

When patients agreed to take part in Grünenthal clinical trials, they gave permission (through informed consent) to use their data to study the medicine or disease that Grünenthal was researching.

Further research must therefore study the medicine or disease that was researched in the original trials.

For future Grünenthal trials, patients will be asked to give permission for broader research beyond the original trial intent so other research may be possible with data from these trials.

Where available, the following anonymized patient level data and redacted documents are provided for clinical trials.

Analysis-ready dataset. This is the STDM dataset used for Grünenthal's analysis.

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 Food and Drug Administration (FDA), the European Medicines Agency (EMA), and any other local health authority. Appendices which include patient level data are not included or will be redacted. To protect research participants' privacy and confidentiality, case narratives are not routinely included. They may be provided where they are needed for a specific research proposal, provided research participants' privacy can be protected.

Further enquiries are not accepted. Please refer to the above sections "Studies listed" and "Exceptions."

Researchers can access further clinical trial documents on the Grünenthal Clinical Trial Portal.

Please see section above and refer to the sections "Studies listed" and "Exceptions".

For more information on Grünenthal clinical trials please visit the Grünenthal Clinical Trial Portal.