Status: Planned First registered on: 03/02/2021
Last updated on: 01/03/2021
1. Study identification
EU PAS Register NumberEUPAS39322
Official titleStrengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability
Study title acronymMINERVA
Study typeOther: EMA Big Data Initiative
Brief description of the studyIdentification of appropriate data sources is becoming an increasing need for regulatory decision making. Metadata are descriptive data that characterise other data to create a clearer understanding of their meaning and achieve greater reliability and quality of information. Access to a standard and electronic set of complete and accurate metadata information can contribute to identifying the datasources that are most suitable for a specific study, describe the datasources planned to be used in a study protocol or research proposal, and contribute to assessing the evidentiary value of the results of a multidatabase observational study submitted in a study report or publication. The objective of this study is to define and collect a set of metadata for a selected number of real-world (RW) datasources. The study consists in the preparatory step for the development and population of a publicly available catalogue of sources of RW data characterised with a common set of metadata. The catalogue will serve as a proof of concept for a metadata inventory with searchability, dynamic dashboards, visualisation capabilities, and integration of different levels of access (public vs. confidential information). Specific objectives of this study are: 1.Define a list of criteria to identify relevant RW datasources from which the datasources to be included in this study will be selected 2.Identify a list of a minimum of 10 datasources for this study 3.Define a set of metadata that should be collected from RW datasources 4.Conduct an in-depth stakeholders’ consultation on the metadata identified 5.Define a process to collect the set of metadata for the datasources in the study 6.Collect the defined set of metadata for datasources in the study 7.Develop a tool enabling access to the metadata collected 8.Draft a good practice guide with the description of the metadata defined and recommendations on its use for the purpose of identifying RW datasources for specific studies
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 belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Details of (Primary) lead investigator
Title Dr
Last name Perez-Gutthann
First name Susana
Is this study being carried out with the collaboration of a research network?
Yes
EU PE&PV Research Network
SIGMA Consortium
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?17

ARS
University Medical Center Groningen, The Netherlands
Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO), Spain
The Spanish Working Group on Chron’s Disease and Ulcerative Colitis (GETECCU), Spain
University of Ljubljana Faculty of Pharmacy, Slovenia
European Society of Blood and Marrow Transplantation, Europe
Countries in which this study is being conducted
International study

Austria
Belgium
Czechia
Denmark
France
Germany
Italy
Netherlands
Slovenia
Spain
Sweden
Switzerland
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed04/01/202123/11/2020
Start date of data collection31/05/2021
Start date of data analysis
Date of interim report, if expected
Date of final study report15/12/2021
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 Perez-Gutthann
First name Susana
Address line 1Av. Diagonal, 605, 9-1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain
Phone number (incl. country code)34932417760 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address sperez@rti.org
Public Enquiries
Title Dr 
Last name Perez-Gutthann 
First name Susana 
Address line 1Av. Diagonal, 605, 9-1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain 
Phone number (incl. country code)34932417760 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address sperez@rti.org 
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