de Vries, Sieta T. http://orcid.org/0000-0001-6090-2434
Denig, Petra http://orcid.org/0000-0002-7929-4739
Andrić, Adriana http://orcid.org/0000-0001-5295-1252
Dimov Di Giusti, Marina
Ptaszynska-Neophytou, Alicia
Härmark, Linda http://orcid.org/0000-0002-9314-9298
Mol, Peter G. M. http://orcid.org/0000-0002-4262-3180
,
Article History
Accepted: 4 July 2021
First Online: 8 August 2021
Declarations
:
: This work was a collaboration between the Web-RADR project and the SCOPE Joint Action. The Web-RADR project has received support from the IMI Joint Undertaking (www.imi.europa.eu) under Grant Agreement no. 115632, the resources of which are composed of a financial contribution from the European Union’s Seventh Framework Programme FP7/2007-2013 and European Federation of Pharmaceutical Industries and Associations (EFPIA) companies’ in kind contribution, UK (www.imi.europa.eu). The SCOPE Joint Action was sponsored by the European Commission. Any opinions, conclusions, and proposals in the text are those of the authors and do not necessarily represent the views of the European Commission.
: Sieta T. de Vries, Petra Denig, Adriana Andrić, Marina Dimov Di Giusti, Alicia Ptaszynska-Neophytou, Linda Härmark, and Peter G.M. Mol have no conflicts of interest that are directly relevant to the contents of this study.
: The data and syntaxes used for this study are available from the corresponding author on reasonable request.
: All authors contributed to the development and formulation of the research question. STdV, AA, MDDG, LH, and PGMM were involved in the distribution of the survey, and STdV and PGMM conducted the analyses. All authors contributed to the interpretation of the data. STdV, PD, and PGMM wrote the manuscript, and AA, MDDG, APN, and LH reviewed and edited the manuscript. All authors have read and approved the final version of the manuscript. This study was a collaboration between the SCOPE Joint Action and the Web-RADR project. The study objective was formulated by members of the SCOPE Work Package 4, and the survey questions were formulated in collaboration with members of the Web-RADR Work Package 3b who performed the survey study. SCOPE Work Package 4 focused on national schemes for the spontaneous reporting of ADRs.
: This study was part of a wider project among HCPs and patients in Europe. The study protocol for the project was submitted to (a member of) an Ethics Committee in the UK, The Netherlands, and Germany. In the UK, approval was obtained from the UCL Research Ethics Committee (project ID number 6855/001). In The Netherlands, the Medical Ethics Committee of the University Medical Center Groningen (METcUMCG) determined that ethical approval was not needed for this study (reference number M16.191043), and in Germany, a review by an Ethics Committee was not needed; therefore, no further approval was deemed necessary for the other countries, including Croatia.
: Participants gave their implied consent to participate in the study by voluntarily completing the survey.
: Not applicable.
: The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of, or reflecting the position of, the Medicines Evaluation Board or one of its committees.
: The authors would like to thank the HCPs and patients who responded to the survey. Acknowledgments go to the other Web-RADR Work Package 3b and SCOPE Joint Action Work Package 4 members.