Step 1: Feasibility assessment by LEO Pharma
LEO Pharma initially assesses whether anonymised patient-level data can be shared from the requested trials, given the conditions of the informed consent agreement with the patients at the time the trial was initiated. Informed consent agreements have differed over time, and in respect of the boundaries of these agreements, a feasibility check must be performed.
To ensure transparency the Patient and Scientific Review Board will receive all Data Availability Forms. In cases where LEO Pharma has assessed that the requested data cannot be delivered within the boundaries of patients’ informed consent or cannot be sufficiently anonymised, the Board will also receive a copy of the informed consent form of the respective trials in an anonymised format, together with a clarification of the assessment made by LEO Pharma.