Status: Finalised First registered on: 07/12/2017
Last updated on: 05/02/2021
1. Study identification
EU PAS Register NumberEUPAS21920
Official titleSurvey to Evaluate the Effectiveness of Risk Minimisation Measures for Atezolizumab Use in the European Union
Study title acronym
Study typeOther: HCP survey
Brief description of the studyThis is a multi-country, one-wave, cross-sectional physician survey to evaluate the effectiveness of additional Risk Minimisation Measures (aRMM) for atezolizumab use, covering receipt of, understanding and use, knowledge and behavior among physicians, and in particular aRMM effectiveness in informing physicians to recognize and manage immune-related adverse drug reactions (irADRs). The online survey questionnaire, comprising multiple-choice and true/false questions, will be conducted in several European countries where atezolizumab has been launched.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOXON
Department/Research groupOXON Epidemiology
Organisation/affiliationOXON Epidemiology Ltd.
Website/Homepagewww.oxonepi.com
Details of (Primary) lead investigator
Title Dr
Last name Di Nucci
First name Flavia
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?300
Countries in which this study is being conducted
International study

Denmark
Germany
Italy
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed12/10/201812/10/2018
Start date of data collection29/04/201930/04/2019
Start date of data analysis
Date of interim report, if expected
Date of final study report06/07/202026/06/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesF. Hoffmann-La Roche Ltd100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Di Nucci
First name Flavia
Address line 11 DNA way
Address line 2 
Address line 3 
CitySan Francisco 
Postcode 
CountryUnited States
Phone number (incl. country code)16502438101 
Alternative phone number 
Fax number (incl. country code) 
Email address di-nucci.flavia@gene.com
Public Enquiries
Title Dr 
Last name TISL 
First name Trial Information Support Line 
Address line 1F. Hoffmann-La Roche Ltd 
Address line 2Grenzacherstrasse 124 
Address line 3 
CityBasel 
Postcode 
CountrySwitzerland 
Phone number (incl. country code)41616881111 
Alternative phone number 
Fax number (incl. country code) 
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