Step 4: Preparation and provision of anonymised patient-level datasets

Following approval, LEO Pharma is responsible for preparing and providing the anonymised patient-level data. The following data can be released after approval of request:

• Anonymised raw data in the format they have been analysed by LEO Pharma and submitted to authorities
• Anonymised analysis data sets required to conduct the requesting researchers’ approved analysis plan
• Supporting documentation assisting the research group in understanding and interpreting the results of the analysis contained in the clinical study report, including:
  • Clinical study protocol
  • Clinical study report
  • LEO Pharma statistical analysis plan update, if available
  • Annotated Case Report Form for the raw data
  • Dataset specifications, if available.

As a prerequisite for getting access to data, the researcher must sign a Data Sharing Agreement with LEO Pharma. The Data Sharing Agreement covers the following terms:

• Data must only be used for the agreed purpose. In this respect, the researcher must also agree that that the analyses/research conducted will not at any point be used for commercial purposes.
• Acceptance to safeguard personal data and not to establish the identities of clinical trial participants.
• LEO Pharma must be informed immediately, and no later than within twenty-four (24) hours, of any potential safety concerns.
• The research/analyses must be completed within 24 months of access to data.
• The results of the analysis must be shared with LEO Pharma.
• Publication of the results in a peer-reviewed journal must be pursued or otherwise make the results publically available.
• Provide LEO Pharma with a copy of the manuscript at the time of journal submission.
• Disclose any potential conflicts of interest.

Timelines for providing the anonymised patient-level data after signing of the data sharing agreement will be agreed upon with the researcher.