Biogen

About	Biogen’s mission is to discover, develop and deliver innovative therapies that improve the lives of patients. We are grateful to the patients, healthy volunteers, families, hospitals and clinics that participate in the clinical trials for testing our potential therapies. Each individual’s participation contributes enormously to our understanding of disease and has the potential to benefit patients around the world. Biogen is committed to supporting clinical trial disclosure and responsible data sharing in compliance with global legal and regulatory requirements and in alignment with the biopharmaceutical industry’s principles.
Studies Listed for Sharing	Biogen-sponsored interventional clinical trials conducted in patients (phase I-IV) for products and indications submitted and approved, since 2004. Data will be provided to the researcher pending approval of a research proposal and a Data Use Agreement signed by the lead researcher and institution.
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 Biogen’s data package(s).
Exceptions	Clinical trials where there is a reasonable likelihood that the study participant could be re-identified, such as with trials of rare diseases and single-center studies. Clinical trials where data sharing is prohibited by the informed consent; or where regulatory, legal, contractual, or other limitations exist. Clinical trials where data/documents are not in English.
When Studies are available for sharing	Data from studies that meet the criteria are available 18 months after study completion. Biogen will routinely update the list of studies available.
Additional Conditions for Access
What information will be provided	We commit to share patient-level data, study-level data, CSRs, and protocols with qualified scientific researchers.
Questions or enquiries	DataSharing@biogen.com
Review Criteria for Data Requests	In determining whether a specific request for access to data and clinical trial information shall be granted, Biogen shall consider all relevant information, including: Data requested Hypothesis to be tested and the rationale for the proposed research Ethical Research Plan Sound Statistical Plan Publication and posting plan Qualifications and experience of requestor or intended researcher(s) and any potential conflicts of interests Source of any research funding Whether the Informed Consents prohibit the proposed research If the proposal has potential to produce information that will enable identification of individual research participants.
Data Request Review Process	Biogen reviews all data requests internally based on the criteria set forth in our Clinical Trial Transparency and Data Sharing Policy. Requests that are denied in whole or in part are then sent to an independent external review body, whose decision will be made transparent.
Access to study documents without participant-level data	Access to the Clinical Protocol and Clinical Study Report may be provided without participant level data, upon approval of the  research  proposal and execution of the Data Use Agreement.
Anonymization Standards	To be provided (in process).
Clinical Study Register or Website	http://clinicalresearch.biogen.com/

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