- PGRx : Central demyelination

Head :
Grimaldi - Bensouda Lamiae

Last update : 06/18/2012 | Version : 2 | ID : 2383

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name PGRx : Central demyelination
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL : 907.069
General Aspects
Medical area Neurology
Others (details) First central demyelinating event, Demyelination, Multiple Sclerosis (MS)
Keywords pharmaco-epidemiology
Scientific investigator(s) (Contact)
Name of the director Grimaldi - Bensouda
Surname Lamiae
Address 10 place de Catalogne, 75014 Paris
Phone 01 55 42 53 00
Collaborations
Funding
Funding status Private
Details LA-SER
Governance of the database
Sponsor(s) or organisation(s) responsible LA-SER
Organisation status Private
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Case control study
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Cases of central demyelination are recruited by a network of neurology and pediatric centers and the referents by a network of general practitioners, distributed all across the territory.
Database objective
Main objective Surveillance and assessment of the risk of central demyelination associated with drug or vaccine use in real life situations.
Inclusion criteria For the cases: patients, males and females aged from 0 to 79 years, having a first central demyelinating event reported by the neurologist, for which the first symptoms of the episode occurred less than 12 months ago.
For the controls: patients, males and females aged from 0 to 79 years, having consulted a general practitioner.
Population type
Age Newborns (birth to 28 days)
Infant (28 days to 2 years)
Early childhood (2 to 5 years)
Childhood (6 to 13 years)
Adolescence (13 to 18 years)
Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Population covered General population
Gender Male
Woman
Geography area International
Detail of the geography area France, Italy, Spain, United Kingdom, Canada
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2007
Size of the database
Size of the database (number of individuals) [10 000-20 000[ individuals
Details of the number of individuals 517 cas et 11125 référents
Data
Database activity Current data collection
Type of data collected Clinical data
Declarative data
Clinical data (detail) Direct physical measures
Declarative data (detail) Phone interview
Presence of a biobank No
Health parameters studied Health event/morbidity
Procedures
Participant monitoring No
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Methods for accessing the database are currently being defined
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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