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.

• Patient identifiers (subject number): Replaced by a new patient ID, consistently across all datasets to keep the patient-record relationship.
• Further unique identifiers (kit numbers, devices, etc.): Removed.
• Site ID: Option1: Replaced by a new site ID, retaining the site-groups. Option 2: Removed.
• Date of birth: Removed. Replaced with age at screening.
• Sex: Retained.
• Age: Option 1: Retained. Option 2: Replaced with age group (5-year, 10-year groups, etc.). In all scenarios: Aggregation of Age >89.
• Race and Ethnicity: Option 1: Retained. Option 2: Low-frequency values pooled (e.g. WHITE, OTHER). Option 3: Removed.
• Country: Option 1: Retained. Option 2: Replaced with regions. Option3: Countries with small numbers of participants pooled together. Option 4: Removed.
• Dates/Times related to study subject: Dates shifted by random shift factor. Same factor for all dates of a patient, however different factor per patient. Time left unchanged.
• Comments, free text, variables containing personally identifiable information (PII), e.g. names, initials: Removed.
• Verbatim term of adverse events and medical history: Verbatim term replaced by coded dictionary terms.
• Verbatim term of concomitant medications: Removed. No replacement by coded dictionary terms due to license restrictions.

Where multiple options are available, the choice of rules to be applied will be determined by the de-identification risk assessment to achieve the required risk threshold while retaining maximum utility of data. Risk is assessed for each request and takes into account study design, population, and request details.

• 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.
• Clinical trials where there are ongoing regulatory activities or publication plans.

Biogen does not generally share imaging data (e.g. DICOM files of images from x-rays, ultrasounds, MRI scans, etc.) and we will only share genomic data with explicit consent.

• There is a potential conflict of interest, or an actual or potential competitive risk
• The data requested is unavailable, not collected, or is not appropriate for the research proposal
• The research proposal’s aim is considered commercial or litigious
• The research proposal lacks clear scientific merit

• The research objective can be met with the collected study data
• The Informed Consents do not prohibit the proposed research
• The data is not subject to legal, regulatory or contractual limitations
• There are no competing publication plans
• Study data and documents are in English
• The proposal does not have potential to produce information that will enable identification of individual research participants
• There are no practical constraints to providing the data (for example, issues related to the format of the databases or excessive operational costs preparing the data)
• 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
• The publication plan for the research
• The plain English summary is clear with sufficient detail to be understood by a non-specialist
• 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

• Data requests are initially reviewed by Vivli and Biogen for completeness and other parameters (relating to scope and meeting sponsor policies) and are then reviewed by an Independent Review Panel
• In certain circumstances, access to data may be declined by Biogen, for example, where there is a potential conflict of interest or an actual or potential competitive risk