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Step 4: Sign an agreement
Researchers must sign a data sharing agreement to ensure that the data is used responsibly, and clinical trial participants are protected.
The decision of the Patient and Scientific Review Board will be communicated by LEO Pharma to the researcher.
For approved research proposals, access is provided based on a Data Sharing Agreement that must be signed by the researcher and LEO Pharma. In the agreement the researcher must agree to certain terms including but not limited to:
- Data must only be used for the agreed purpose.
- Personal data must be safe-guarded, and no attempt must be made to establish the identities of clinical trial participants.
- LEO Pharma must be informed immediately, and no later than within 24 hours, of any potential safety concerns.
- Any potential conflicts of interest must be disclosed.
The non-negotiable Data Sharing Agreement must be signed by both the researcher and LEO Pharma, before LEO Pharma can initiate the preparation of the anonymized data.
Download the Data Sharing Agreement template
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