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Clinical Studies Data Transparency Policy Access to Patient-Level Clinical Study Data
 

Access to Patient-Level Clinical Study Data

 

 

 

UCB believes that sharing data with other researchers will advance science, lead to new discoveries and treatments, and ultimately help patients.


UCB accepts requests from qualified researchers for access to anonymized patient-level data and redacted study documents via a multi-sponsor request management system, Vivli.org.


UCB’s Policy for Access to Patient-Level Clinical Study Data is:

Data may be requested:

From Phase 2-4 interventional clinical studies of EU and US approved products or indications that began after 1 January 2007

At least six months after EU and US approval or global discontinuation of development and 18 months after the end of the study

In addition, Phase 2-3 interventional clinical studies that were included in an approved marketing application in the US and EU after 01 January 2015 are also available for request.

The following information is available for request.

  • Raw dataset: data collected for each patient in the clinical study.
  • Analysis-ready dataset: datasets used for UCB's analysis.
  • Protocols with any amendments: a document describing the objectives, design, methodology, statistical considerations, and organization of a clinical study.
  • Annotated case report form: a blank case report form with descriptions of the data collected and how they are described in the dataset.
  • Statistical analysis plan with any amendments: a document describing the planned methods of statistical analysis and procedures for data handling UCB used for the clinical study.
  • Dataset specifications (data dictionary): a document listing the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, and formats.
  • Clinical study report: the full report of efficacy and safety data from the study. It forms the basis of marketing application submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices which include patient-level data, commercially confidential information, or investigator-specific information are redacted. To protect research participants' privacy, case narratives are redacted.

 

All clinical study documents are redacted to comply with data privacy laws as well as to protect any commercially confidential information. All patient-level clinical study datasets are anonymized to protect the privacy of study participants.
Data sharing requests