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central

Cohort Belonging to The National Network of Schizophrenia Expert Centres

France, 2009
Reference ID
FRESH-PEF73248-en
Producer(s)
Marion;LEBOYER, Pierre-Michel;LLORCA
Metadata
DDI/XML JSON
Created on
Dec 18, 2025
Last modified
Dec 18, 2025
Page views
3
  • Study Description
  • Get Microdata
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access
  • Contacts
  • Metadata production
  • Identification

    Survey ID number

    FRESH-PEF73248-en

    Title

    Cohort Belonging to The National Network of Schizophrenia Expert Centres

    Abbreviation or Acronym

    FACE-SZ

    Country
    Name Country code
    France fr
    Kind of Data

    ['Clinical data','Participant-reported health data','Biological data']

    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary
    Psychiatry health theme
    Addiction medicine health theme
    Schizophrenia cim-11
    Behavioral determinants: Addiction health determinant
    Socio-demographic and economic determinants health determinant
    Biological determinants: Genetic predisposition health determinant
    Healthcare system determinants: Use of care health determinant
    Behavioral determinants health determinant
    Behavioral determinants: Eating habits health determinant
    Socio-demographic and economic determinants: Employment health determinant
    Biological determinants health determinant
    Healthcare system determinants health determinant
    Keywords
    DNA RNA serum toxoplasmosis schizophrenia monitoring clinical development staging biomarkers biobank neuropsychology biology vitamin D

    Coverage

    Universe

    {
    "level_sex_clusion_I": [
    {
    "value": "Male",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008297"
    }
    },
    {
    "value": "Female",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D005260"
    }
    }
    ],
    "level_age_clusion_I": [
    {
    "value": "Young Adult (19 to 24 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D055815"
    }
    },
    {
    "value": "Adult (25 to 44 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000328"
    }
    },
    {
    "value": "Middle Aged (45 to 64 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008875"
    }
    },
    {
    "value": "Aged (65 to 79 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000368"
    }
    }
    ],
    "level_type_clusion_I": "Patients population",
    "level_type_clusion_other": "",
    "clusion_I": "",
    "clusion_E": ""
    }

    Producers and sponsors

    Primary investigators
    Name
    Marion;LEBOYER
    Pierre-Michel;LLORCA
    Producers
    Name
    FONDATION FONDAMENTAL
    Funding Agency/Sponsor
    Name
    AGENCE NATIONALE DE LA RECHERCHE (ANR)

    Sampling

    Sampling Procedure

    ['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']

    Survey instrument

    Questionnaires

    Access on specific project only

    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start
    2009-01-01
    Mode of data collection
    • {"concept":{"vocabURI":"Transcription","vocab":"CESSDA"},"value":"Converting or copying information into a structured record"}

    Study activities

    Study activities
    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception

    Quality standards

    Other quality statement

    ['All studies may be audited by the sponsor at any time. The investigator and his/her team shall make themselves available during the auditor visits, as well as allowing auditors access to technical facilities, study material and patient records. Patient anonymity must be respected and information verified during these tests must remain confidential. 9.6. Quality control by health authorities. The following items may be checked during prospective inspections by the health authorities: – General organisation of the study – qualifications of the staff conducting the study – equipment quality – informed consent forms – CPP (Ethics Research Committee) approval – product delivery and storage methods – conduct of the study – archiving documentation related to the study. In the event of inspection by the authorities, the investigator shall notify the sponsor as the soon as the request is made.']

    Data Access

    Access conditions

    All requests from the public or private research body must be approved by the steering committee based on the submission of a project. 1. General Conditions. Access to clinical, neuropsychological and socioeconomic data, as well as biological samples, shall be possible for both private and public teams that participated in the creation of such collections and teams located in France or abroad. Requests for transferring data (clinical, neuropsychological or socioeconomic) and assigning biological samples will be validated by the scientific committee involved in the study, who will issue its decision based on: – the scientific relevance of the proposed study; – non-competition with research already begun by teams participating in creating the collection; – sample availability. It should be noted in this context that the requirements for obtaining available biological data by type and number shall differ from clinical, neuropsychological or socioeconomic data requirements. The ownership of results and potential terms of transfer (price, publications, etc.) will be drawn up in a contract. Samples will only be available by written request from the initiator throughout the duration of the study (Transfer Agreement). The Transfer Agreement authorises the release of certain samples according to specific conditions (recipient, transport cost, return of unused samples, publication requirements, etc.). All requests are approved in advance by the collection scientific committee, whose members include the head of the CRB in Mondor and the CRB in Pitié-Salpêtrière. Secondary use biological samples for research other than that initially planned is not possible without prior consent and following approval from the cohort scientific committee, as well as the establishment of a Transfer Agreement between the CRB. In the event of biomedical research organised by a public institution or private organisation, the use of human biological samples for research must involve drafting a Material Transfer Agreement (MTA); a contract that ensures the protection of intellectual property belonging to the Fondation FondaMental for research development and patent applications. 2. Access conditions for clinical data. The availability of clinical, neuropsychological or socioeconomic data will be finalised following approval by the steering committee. The requested items will be sent in the form of a database. 3. Access conditions for biological material. The availability of human biological materials kept at the biological resource centre (CRB) as part of the PSY-COHORTE SZ cohort will be finalised according to that set forth in the Research Collaboration Contract previously established between the Fondation FondaMental and heads from various organisations. The contract shall specify the beginning and end of the study; CRB obligations regarding the expected deliverables; guarantees regarding the quality and security of stored samples (preserving anonymity, monitoring temperature, etc.). The financial commitment terms should also be reiterated.

    Availability Status

    {"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}

    Restrictions

    Those with direct access in accordance with the laws and regulations in force, particularly Articles L.1121-3 and R.5121-13 of the Public Health Code (e.g. investigators, people in charge of quality control, monitors, clinical research assistants, auditors and all individuals duly authorised by the sponsor), shall take all necessary precautions to ensure the confidentiality of information related to experimental drugs, trials and participating individuals, particularly with regards to their identity and the results obtained. Data collected by these parties during quality control or auditing procedures shall be made anonymous.

    Contacts

    Contacts
    Name Email
    Marion;LEBOYER marion.leboyer@inserm.fr
    Pierre-Michel;LLORCA pmllorca@chu-clermontferrand.fr

    Metadata production

    DDI Document ID

    FRESH-PEF73248-en

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