Interactions between Lundbeck and applicants applying for access to data and information are intended to be collaborative. Lundbeck is charged with assisting applicants to submit access to data and information requests that can be granted, consistent with the foregoing principles.
All applications from researchers for access to Lundbeck data and information will be reviewed by the:
Scientific Review Board (SRB) which is responsible for assessing and deciding upon applications from qualified and medical researchers for access to anonymized individual patient data (“IPD”) or redacted clinical study reports (CSR) from clinical trials sponsored by Lundbeck or development partner. The charter for the SRB can be be viewed here and the composition of the SRB is:
Each member participates in a personal capacity, and does not represent any organisation or institution with which he or she may be affiliated. View the biographies here.
In determining whether a specific request for access to data and clinical trial information shall be granted, the SRB will consider all relevant information, including:
Researchers are responsible for gaining any other approvals that are required for the research (for example, from Ethics Committees, Institutional Review Boards, relevant research institutions or funding bodies).