How to access clinical trial datasets
  • No attempt to identify or contact research subjects.
  • Use the data only for the purposes described in the research proposal.
  • No dissemination or sharing of the data with any third parties not mentioned in the research proposal.
  • No use of the data for any commercial purposes.
  • Agreement that Novo Nordisk gets a fully paid-up, unrestricted non-exclusive license to any and all inventions that may result from the analysis of Novo Nordisk data.
  • Immediate notification of Novo Nordisk and relevant health authorities of any health or safety concerns that may have arisen from the analysis of Novo Nordisk data.
  • Declaration of the intent to publish findings of scientific and medical importance in relevant peer-reviewed journals.

 

Mandatory elements to be included in access requests

Data Sharing Agreement

A signed copy of the Data Sharing Agreement (DSA) should be included. The Data Sharing Agreement is to be sent:

• as a scanned copy in the access request email

• as a hard copy with the original signatures to the lRB Secretariat at the following address:

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

External Innovation & Stakeholder Relations – IRB Secretariat

ATT: Executive Assistant to CVP, External Innovation & Stakeholder Relations

(Note: If you wish to receive a hard copy of the countersigned DSA for your own records, please submit two signed originals.)

Potential conflicts of interest outside the funding of the proposed research

For each member of the research team please provide:

  • Financial relationships that could be perceived to influence the planning, conduct or interpretation of the research:
    • Board membership
    • Consultancies
    • Employments
    • Grants
    • Patents
    • Royalties
    • Stocks/shares
    • Non-financial real or potential conflict of interest that could be perceived to influence the planning, conduct or interpretation of the proposed research. For example potential biases based on pre-existing personal views, academic or commercial competition, personal relationships or institutional affiliation

Funding of the proposed research

Name the funding source (list grants from governments, agencies, donations, funding from employers, consultancies, honoraria and commercial funding from for profit organisations or other payments that will be used for the research)

Research team information

The research team (list the team members with name, post/position and abbreviated CV)

Research proposal information

  • Title of the proposed research
  • Scientific rationale and relevance of the proposed research describing the objectives and the hypotheses corresponding to the objectives of the research
  • Short lay summary of the proposed research intended for public disclosure
  • Research methodology and data (brief description of the intended method for the use of the requested data and a detailed description of the different data sources of the data that is intended to be included)
  • Statistical analysis plan (include a description of the endpoints and their time points and the planned statistical analyses including the analysis set, the analysis models (with factors and covariates), any transformation of data, plans for handling of missing data, plans for addressing multiplicity issues and plans for sensitivity analyses)
  • Publication plan (list the planned number of abstracts and manuscripts (i.e. ‘working title of these’) and the scientific congresses under consideration for presentation of the research findings. Include the anticipated timelines)