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Novo Nordisk A/S

About Novo Nordisk supports secondary use of data from Novo Nordisk-sponsored clinical studies for conducting further legitimate scientific research as set out in the joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing.
How we share on the Vivli Platform As a data access requestor, you can submit a scientific research proposal which documents the legitimacy of your research project and the qualifications of your research team using the Vivli request form.

More information is available on Novo Nordisk Trials.
Anonymization Standards   The following data protection procedures for personally identifiable information are performed by Novo Nordisk prior to data sharing:

  • 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.): Suppressed
  • Site ID: Replaced by a new site ID or suppressed
  • Date of birth: Suppressed
  • Sex: Retained or suppressed
  • Age: Replaced with age group or suppressed
  • Race and Ethnicity: Suppressed or retained
  • Country: Replaced with continent or retained or suppressed
  • BMI: Replaced with groups or suppressed
  • Height/Weight: Suppressed or replaced with groups
  • Dates/Times related to study subject: Dates shifted by randomized date offset, time left unchanged
  • Comments, free text, variables containing personally identifiable information (PII), e.g., names, initials: Suppressed
  • Verbatim term of adverse events and medical history: Verbatim terms are suppressed; some dictionary coded terms are retained while others are suppressed
  • Verbatim term of concomitant medications: Verbatim terms are suppressed; dictionary coded terms are mostly retained

Where multiple options are available, the choice of rules to be applied is determined by the risk assessment to achieve the required risk threshold while retaining maximum utility of data. For further details regarding the anonymization process, please write to DataAccess@novonordisk.com.
Studies Listed for Sharing Access to anonymized individual participant‑level data and redacted study documents may be requested for Novo Nordisk‑sponsored phase 2–4 studies with study start after January 2014, provided the product’s indications are approved for marketing in both the EU and the US.

Studies not found in the Vivli search list can still be requested via the Vivli Platform, sharing of these will be considered on a case-by-case basis.
Exceptions Novo Nordisk may choose to reject data access requests if:

  • Data cannot be anonymized sufficiently.
  • The studied product/indication has not obtained marketing approval in the EU and the US.
  • There is a potential conflict of interest, or there is an actual or potential competitive risk.
  • Data is intended to be used for a commercial purpose.
Questions or enquiries Questions and enquiries can be sent to the Novo Nordisk Data Access Team at DataAccess@novonordisk.com.
When studies are available for sharing Novo Nordisk will review the list of studies bi-annually and add studies which meet the above-mentioned criteria as they become available.
Review Criteria for Data Requests All data sharing requests are reviewed to ensure that data sharing is lawful and ethical according to Novo Nordisk internal guidance, e.g.:

  • There is a legal basis for sharing the data for secondary purposes.
  • Anonymization is feasible, e.g., size of the dataset, special populations, rare diseases.
  • Vulnerable populations can be protected.
  • The proposed research does not have a commercial purpose.
  • Commercially confidential information can be protected.
  • The request proposal does not conflict with internal business critical research activities.
Additional Conditions for Access Research teams should have relevant qualifications to conduct the proposed research project and include a biostatistician.
Data Request Review Process Data requests will be reviewed internally and must be approved according to established Novo Nordisk governance frameworks. Upon approval by Novo Nordisk, data sharing requests and research proposals will be reviewed by the Vivli Independent Review Panel.
What information will be provided Novo Nordisk will share anonymized study participant-level data, redacted study protocols, and a description of the data set.

Upon specific request, Novo Nordisk can provide redacted CSRs and empty CRFs.
Access to study documents without participant-level data Novo Nordisk makes CSR Synopses available on our clinical study website. Additionally, Clinical Document Packages per Health Canada’s PRCI and EMA’s Policy 0070 are disclosed on agency-controlled websites.
Clinical Study Register or Website https://www.novonordisk-trials.com/
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