Review of application

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:

  • Eduard Vieta (chair), Professor of Psychiatry, Hospital Clinic at University of Barcelona, Spain
  • Michael Thase, Professor of Psychiatry, Perelman School of Psychiatry of the University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center. Director, Mood and Anxiety Disorders Treatment and Research Center,USA
  • Mary G. Baker, Dr, MBE President, European Brain Council, UK
  • Per Kragh Andersen, Professor, University of Copenhagen Dept. of Public Health, Denmark

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:

  • Text in the study's informed consent regarding sharing of information with others,  availaility of data and are other studies (IITs or alike) ongoing with the same objectives
  • Data requested
  • Hypothesis to be tested and the rationale for the proposed research
  • Statistical analysis plan
  • Publication and posting plan
  • Qualifications and experience of applicant and identified researchers of intererest, and any potential conflicts of interests
  • Source of any research funding

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).

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