Status: Ongoing First registered on: 20/03/2018
Last updated on: 02/04/2018
1. Study identification
EU PAS Register NumberEUPAS23245
Official titleSystematic Review and meta-analysis of PASS Studies Assessing the Effectiveness of Risk Minimisation Measures
Study title acronym
Study typeOther: Systematic Review and Meta-analysis
Brief description of the studyRisk minimisation measures are designed to mitigate potentially manageable risks of medicines. The effectiveness of these measures is uncertain. This cumulative systematic review and meta-analysis of PASS studies conducted to evaluate the effectiveness of risk minimisation studies provides data upon which to assess the future role of these studies.
Was this study requested by a regulator?No
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 belongsOXON
Department/Research groupOXON Epidemiology
Organisation/affiliationOXON Epidemiology Ltd.
Website/Homepagewww.oxonepi.com
Details of (Primary) lead investigator
Title Dr
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.)
First name Nawab
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?3
Bayer Epidemiology, Berlin
Countries in which this study is being conducted
International study

Germany
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed28/03/2016
Start date of data collection28/03/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report25/05/2018
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
OtherOXON Epidemiology100
5. Contact details for enquiries
Scientific Enquiries
Title Miss
Last name Artime
First name Esther
Address line 1C/ DOCTOR FLEMING, 51 | 28036
Address line 2 
Address line 3 
CityMadrid 
Postcode 
CountrySpain
Phone number (incl. country code)34-810512330 
Alternative phone number 
Fax number (incl. country code) 
Email address esther.artime@oxonepi.com
Public Enquiries
Title Dr 
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.) 
First name Nawab 
Address line 1THE OFFICE GROUP EASTSIDE KING’S CROSS | LONDON N1C 4AX – UK 
Address line 2 
Address line 3 
CityLondon 
Postcode 
CountryUnited Kingdom 
Phone number (incl. country code)34-913459395 
Alternative phone number 
Fax number (incl. country code) 
Email address n.qizilbash@oxonepi.com 
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