- PGRx: Acute Liver Damage
Head :
Grimaldi - Bensouda Lamiae
Last update : 07/10/2014 | Version : 1 | ID : 3988
| General | |
| Identification | |
| Detailed name | PGRx: Acute Liver Damage |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | 908.025 |
| General Aspects | |
| Others (details) | Acute liver damage |
| Keywords | Pharmacoepidemiology |
| 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 |
| contact@la-ser.com | |
| 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 by an intermediary |
A selection of health care professionals |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Cases of acute liver damage are recruited by a network of hepatology or gastroenterology centres and by referrals from a network of general practitioners located throughout the territory. |
| Database objective | |
| Main objective | Surveillance and assessment of the risk of liver damage from drug exposure during actual treatment. |
| Inclusion criteria | Case subjects: patients, men or women over 18 years old, with acute liver damage confirmed by a specialist and followed-up for a maximum of 6 months before recruitment. Case-controls: patients (men and women over 18 years old) who have consulted a general practitioner |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | France, Germany |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | - 60 cas/cases - 13000 témoins/controls |
| 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 | |
| Link to the document | http://www.em-consulte.com/en/article/211579 |
| Link to the document | http://www.em-consulte.com/en/article/211579 |
| Link to the document | http://www.em-consulte.com/en/article/211579 |
| Link to the document | http://www.em-consulte.com/en/article/211579 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | To be defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
