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

The decision of the Patient and Scientific Review Board will be communicated by the secretariat of LEO Pharma to the researcher within 15 working days of the Board meeting.

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.

The Data Sharing Agreement template is provided here. Note that there may be minor modifications to the actual agreement.

It is estimated that it will take up to 30 working days to provide anonymised patient-level data after signing of the data sharing agreement.