Status: Finalised First registered on: 07/04/2015
Last updated on: 18/02/2019
1. Study identification
EU PAS Register NumberEUPAS9312
Official titleStudy to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study
Study title acronym
Study typeObservational study
Brief description of the study
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
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 belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagewww.rtihs.org
Details of (Primary) lead investigator
Title Dr
Last name Andrews
First name Elizabeth
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?5
Countries in which this study is being conducted
International study

Austria
Czech Republic
France
Netherlands
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/08/201418/08/2014
Start date of data collection25/05/201526/06/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report30/06/201615/08/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer Pharm100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Andrews
First name Elizabeth
Address line 1RTI-Health Solutions
Address line 2200 Park Offices Drive 
Address line 3 
CityResearch Trangle Park 
Postcode 
CountryUnited States
Phone number (incl. country code)0119195415819 
Alternative phone number 
Fax number (incl. country code) 
Email address eandrews@rti.org
Public Enquiries
Title Professor 
Last name Bayer HealthCare AG 
First name CTP Team / Ref: "ENCePP"/ Bayer Pharma AG 
Address line 1Müllerstraße 178 
Address line 2 
Address line 3 
CityBerlin 
Postcode 
CountryGermany 
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-contact@bayerhealthcare.com 
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