UCB

About	UCB is a global biopharmaceutical company focused on creating value for people living with severe diseases in immunology and neurology. Members of the UCB group of companies include: – Ra Pharmaceuticals, Inc. – Zogenix Inc.
How we share on the Vivli Platform	Available studies are listed and searchable on the Vivli Platform. Data requestors should use the Vivli Data request form to request UCB data package(s). If approved, requesters will need to sign a Data Use Agreement and the anonymized data will be shared in the Vivli secure research environment.
Studies listed for sharing	UCB will list UCB-sponsored interventional clinical trials from medicines and indications approved in the United States (US) and European Union (EU) in the following categories: To be eligible for sharing, all clinical trials must have been part of an approved Marketing Application in US and/or EU or a global discontinuation of product development by UCB has occurred. In addition, 18 months must have passed since the end of the trial. Phase 2, 3, or 4 global clinical trials in indications approved in both the US and EU with a first patient visit after 1 January 2007. Phase 2 or 3 clinical trials in indications approved in both the US and EU on or after 1 January 2015. Requests for access outside of the scope of the above will be considered on a case-by-case basis.
Exceptions	UCB cannot share clinical trial data if it cannot be anonymized or when there is a reasonable likelihood that the individual data could be used to re-identify a trial participant. This may include clinical trials of rare diseases, trials with a limited number of sites, or clinical trials with a small number of participants.
When Studies are available for sharing	Studies are available 6 months after the studied medicine and indication have been approved by regulators in the US and EU and 18 months after the clinical trial ends, whichever is later.
Additional Conditions for Access	A condition of providing the data to an external researcher is that the external researcher seeks publication of his/her research results in a peer-reviewed journal. UCB is to be provided with a copy of the manuscript for review prior to journal submission to prevent the unintended disclosure of UCB’s confidential information. In exceptional circumstances, access to data may be declined by UCB, for example, where there is a potential conflict of interest or an actual or potential competitive risk.
What information will be provided	Where available, the following anonymized patient level data and information is provided in English only for each clinical trial: Analysis-ready dataset. This is the dataset used for UCB’s analysis. Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial. Annotated case report form. This is 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. This describes methods of analysis and procedures for data handling UCB used for the trial. Dataset specifications (data dictionary). This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats. Clinical study report. This is the full report of efficacy and safety data from the trial. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices which include patient level data, confidential information, or investigator-specific information are redacted. To protect research participants’ privacy, case narratives are redacted. All clinical trial documents are redacted to protect the personally-identifiable information (PII) of trial participants as well as any commercially confidential information (CCI). All patient-level clinical trial datasets are anonymized to protect the privacy of trial participants.
Questions or enquiries	Researchers can enquire about the availability of data from UCB-sponsored clinical trials that are not listed on the site before they submit a research proposal.
Review Criteria for Data Requests	The data and studies are available to perform the analysis. The planned analysis can be conducted in the data access system. The scientific rationale and relevance of the proposed research to medical science or patient care. The ability of the proposed research plan (design, methods and analysis) to meet the scientific objectives. This is a high-level review. The publication plan for the research. Real or potential conflicts of interest that may impact the planning, conduct or interpretation of the research and proposals to manage these conflicts of interest. The qualifications and experience of the research team to conduct the proposed research (a statistician with a degree in statistics or a related discipline should be part of the research team).
Data Request Review Process	Data requests are initially reviewed by Vivli and UCB for completeness and other parameters (relating to scope, system-compatibility, and meeting sponsor policies) and are then reviewed by a fully Independent Review Panel.
Access to study documents without participant-level data	In addition, UCB accepts enquiries for clinical document-only access (consistent with the above data sharing policies) by completing the online Enquiry Form.
Anonymization Standards	Providing access to data in ways that allow further research while maintaining the privacy and confidentiality of research participants is critical. UCB prepares data for sharing with researchers in a way that: • Minimizes risks to the privacy and confidentiality of research participants • Ensures compliance with data privacy legal requirements From 2021, UCB has implemented a quantitative risk-based approach for the anonymization of clinical trial data and documents. Structured datasets will be anonymized by following reference industry practices such as rules and guidelines published by the Phuse and TransCelerate organizations. The best efforts will be made to maintain data utility while applying the anonymization rules. Consistent methodology will be applied to the study documents and an anonymized version of Clinical Study Report, Study Protocol, Study SAP will be shared alongside the datasets. An Anonymization Report may be provided for the description of the transformations applied to the study variables without releasing any sensitive or re-identifying information. Please note that a subset of studies posted earlier on Vivli may be anonymized by using an alternative validated methodology (such as rule based methodology for example). For those studies, the study companion documents will be redacted.
Clinical Study Registrar or Website	https://www.ucb.com/clinical-studies/clinical-studies-index

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