Granhall, Charlotte
Donsmark, Morten
Blicher, Thalia M.
Golor, Georg
Søndergaard, Flemming L.
Thomsen, Mette
Bækdal, Tine A.
Funding for this research was provided by:
Novo Nordisk
Article History
First Online: 18 December 2018
Compliance with Ethical Standards
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the studies.
: This study was funded by Novo Nordisk.
: Charlotte Granhall, Morten Donsmark, Thalia M. Blicher, Flemming L. Søndergaard and Tine A. Bækdal are employees and shareholders of Novo Nordisk A/S. Mette Thomsen is an employee of Novo Nordisk A/S. Georg Golor declares no conflicts of interest.
: <i>Will individual participant data be available (including data dictionaries)?</i> Individual participant data will be shared in data sets in a de-identified/anonymised format. <i>What data in particular will be shared?</i> Data sets from Novo Nordisk sponsored clinical research completed after 2001 for product indications approved in both the EU and US. <i>What other documents will be available?</i> Study protocol and redacted Clinical Study Report (CSR) will be available according to Novo Nordisk data sharing commitments. <i>When will data be available (start and end dates)?</i> The data will be available permanently after research completion and approval of product and product use in both the EU and US. No end date. <i>With whom will data be shared?</i> With bona fide researchers submitting a research proposal requesting access to data. <i>For what types of analyses?</i> For use as approved by the Independent Review Board (IRB) according to the IRB Charter (see ExternalRef removed). <i>By what mechanism will data be made available?</i> Access request proposal form and the access criteria can be found at ExternalRef removed. The data will be made available on a specialised SAS data platform.