Step 5: Receive the dataset

After the researcher has signed the Data Sharing Agreement, LEO Pharma will anonymize the requested data. Without anonymizing our clinical data, it is not possible to share data in compliance with the General Data Protection Regulation (GDPR). Risk-based anonymization aims to modify the dataset, to remove any identifiable information while preserving its statistical properties. Although the aim is to retain as much data utility as possible, anonymization requires some modification of the data, which might include masking or transformation. Not all variables will be available as original values in the anonymized dataset.

LEO Pharma will send the anonymized patient-level data to the researcher via a secured file transfer protocol (sFTP). Supporting documentation will also be provided to help understand the data, such as the study protocol, statistical analysis plan, annotated case report form and data recipient report. LEO Pharma can only provide limited statistical support.