Access can be granted to datasets from Novo Nordisk sponsored clinical studies completed after 2001 for product indications approved in both the EU and US, if Novo Nordisk assesses that they can be effectively de-identified to protect patient anonymity. Researchers can complete searches for studies of interest here.
In order to get access to a specific dataset, researchers must submit their research proposal. In doing so the researcher accepts a number of legal provisions, including without limitation:
Before the request is forwarded to the Independent Review Board, the Secretariat supporting the Independent Review Board checks whether all the mandatory elements of the research proposal have been included. The Secretariat also checks whether the request pertains to data from Novo Nordisk sponsored trials completed after 2001 on Novo Nordisk product indications approved in both the EU and US and whether the data is already listed in the Novo Nordisk data sharing system.
If the requested data is not already listed, the Secretariat will conduct an assessment of the practicalities and timelines for granting the access. More information about this is included in the Independent Review Board Charter.
The Independent Review Board assesses all complete requests and approves or rejects the proposal without any interference from Novo Nordisk. For the details of how the Independent Review Board operates, please see the Independent Review Board Charter.
The Independent Review Board meets every quarter, depending on whether any access requests have been received, to discuss and make decisions on access requests submitted until five weeks before the Independent Review Board meeting. The Independent Review Board communicates its final decisions directly to the requesters and to Novo Nordisk.
In case of approval, Novo Nordisk provides the trial dataset which is de-identified to protect patient anonymity together with the redacted Clinical Study Report, thus enabling the researcher to complete the proposed analysis. The data access is granted within a web-based system that includes a statistical computing environment. Access will be limited to data from the specific trial(s) noted in the request.
The researcher must then complete the study and notify the Independent Review Board Secretariat of any pending publications.
Complete access requests will be listed and their status tracked once the access has been granted.
The research team (list the team members with name, post/position and abbreviated CV)
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)
For each member of the research team please provide:
A signed copy of the Data Sharing Agreement (DSA) should be included. The Data Sharing Agreement is to be sent:
Novo Nordisk A/S
Att: IRB Secretariat, Clinical Transparency and Medical Writing Office
Vandtårnsvej 114, DK-2860 Søborg, Denmark, email@example.com
(Note: If you wish to receive a hard copy of the countersigned DSA for your own records, please submit two signed originals.)