Cohort Belonging to The National Network of Schizophrenia Expert Centres FRESH-PEF73248-en Cohort Belonging to The National Network of Schizophrenia Expert Centres FACE-SZ FRESH-PEF73248-en 73248 FRESH-PEF73248 Marion LEBOYER Pierre-Michel LLORCA FONDATION FONDAMENTAL Epidemiology France Portal (PEF) AGENCE NATIONALE DE LA RECHERCHE (ANR) null Marion;LEBOYER Pierre-Michel;LLORCA DNA RNA serum toxoplasmosis schizophrenia monitoring clinical development staging biomarkers biobank neuropsychology biology vitamin D Psychiatry Addiction medicine Schizophrenia Behavioral determinants: Addiction Socio-demographic and economic determinants Biological determinants: Genetic predisposition Healthcare system determinants: Use of care Behavioral determinants Behavioral determinants: Eating habits Socio-demographic and economic determinants: Employment Biological determinants Healthcare system determinants The objective of the National Network of Schizophrenia Expert Centres is to offer diagnostic and therapeutic advice for patients with schizophrenic disorders and then monitor them for a period of three years. These patients will be thoroughly evaluated based on psychiatric (primary and related illnesses); psychological; somatic; cognitive and social assessment (impact of disease on functional outcome). null France Individuals Patients population Male Female Young Adult (19 to 24 years) Adult (25 to 44 years) Middle Aged (45 to 64 years) Aged (65 to 79 years) All patients with schizophrenia and related disorders (schizophreniform or brief psychotic disorder) may participate in cohort monitoring, with no exclusion criteria. These disorders are effectively heterogeneous in nature, from clinical manifestations to illness progression and associated pathologies. The data from this cohort may be the only tool for studying the trajectory of the disease in the long term in accordance with different clinical profiles, differences in treatment and identifying aggravating factors. Due to the clinical heterogeneity of schizophrenia, given the characteristics of the disorder, but also the frequency of related somatic and psychiatric illnesses, it is important to monitor these cohorts in order to identify new treatment strategies and to follow-up specific target subgroups. Clinical data Participant-reported health data Biological data 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. Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception Other [1000-10000[ individuals Converting or copying information into a structured record Medico-administrative database Observational Study Observational Study Cohort study The network of centres is intended to be a permanent structure where the number of assessed individuals is not restricted. Unknown Restricted access 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. 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. Access on specific project only