Status: Finalised First registered on: 24/01/2020
Last updated on: 21/04/2021
1. Study identification
EU PAS Register NumberEUPAS32408
Official titleImpact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: risk awareness and adherence
Study title acronymRetinoidRiskAware
Study typeOther: Cross-Sectional Study
Brief description of the studyThis is a multi-country study in eight European countries: Belgium, Denmark, Greece, Latvia, Portugal, The Netherlands, Slovenia and Spain. In each country a web-based questionnaire will be conducted among users and former users of oral retinoids, and among health care professionals. An electronic survey including questions on the influence of regulatory recommendations on HCP awareness about the teratogenic and neurodevelopment effects of oral retinoids will be used to gauge their perspective and to assess effects on knowledge, attitudes and practices. Similary a patient questionnaire will measure awareness about regulatory recommendations as well as uptake of pregnancy prevention measures, and investigate their effect on oral retinoid use. Data from the survey and questionnaire will be anonymised and analysed for differences between countries. Determinants for adherence to the measures implemented per country will be analysed. Additionally, in two countries (Netherlands and Portugal) semi-structured telephone interviews will be held with 6-8 patients with a range in age and varied educational background.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsUtrecht University Pharmacoepidemiology Center
Department/Research groupDivision of Pharmacoepidemiology & Clinical Pharmacology
Organisation/affiliationUtrecht Institute for Pharmaceutical Sciences
Website/Homepagewww.uu.nl/pecp
Details of (Primary) lead investigator
Title Dr
Last name Klungel
First name Olaf
Is this study being carried out with the collaboration of a research network?
Yes
Pharmacoepidemiology and Pharmacovigilance Network
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?9

Pharmaceutical Care Unit – Ghent University, Ghent, Belgium
University of Copenhagen, Faculty of Health and Medical Sciences, Department of Pharmacy (Social and Clinical Pharmacy)., Copenhagen, Denmark
The Institute of Public Health of Riga Stradins University, Riga, Latvia
University of Ljubljana, Faculty of pharmacy, Social Pharmacy., Ljubljana, Slovenia
Sección de Innovación y Organización, Servicio Navarro de Salud., Pamplona, Spain
Centre for Health Protection, National Institute for Public Health and the Environment, Bilthoven, The Netherlands
Countries in which this study is being conducted
International study

Belgium
Denmark
Greece
Latvia
Netherlands
Portugal
Slovenia
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed25/02/201925/02/2019
Start date of data collection25/10/201925/10/2019
Start date of data analysis20/12/2019
Date of interim report, if expected24/07/2020
Date of final study report23/08/201901/04/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherEuropean Medicines Agency100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Leonardo Alves
First name Teresa
Address line 1National Institute for Public Health and the Environment (RIVM)
Address line 2Centre for Health Protection (GZB) 
Address line 3Postbak 12, P.O.Box 1 
CityBilthoven 
Postcode3720 BA 
CountryNetherlands
Phone number (incl. country code)31-30-2743238 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Leonardo Alves 
First name Teresa 
Address line 1National Institute for Public Health and the Environment (RIVM) 
Address line 2Centre for Health Protection (GZB) 
Address line 3Postbak 12, P.O.Box 1 
CityBilthoven 
Postcode3720 BA 
CountryNetherlands 
Phone number (incl. country code)31-30-2743238 
Alternative phone number 
Fax number (incl. country code) 
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