FRESH-PEF73248-en
Cohort Belonging to The National Network of Schizophrenia Expert Centres
FACE-SZ
| Name | Country code |
|---|---|
| France | fr |
['Clinical data','Participant-reported health data','Biological data']
Individuals
| 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 |
{
"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": ""
}
| Name |
|---|
| Marion;LEBOYER |
| Pierre-Michel;LLORCA |
| Name |
|---|
| FONDATION FONDAMENTAL |
| Name |
|---|
| AGENCE NATIONALE DE LA RECHERCHE (ANR) |
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access on specific project only
Observational Study
| Start |
|---|
| 2009-01-01 |
['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.']
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.
{"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}
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.
| Name | |
|---|---|
| Marion;LEBOYER | marion.leboyer@inserm.fr |
| Pierre-Michel;LLORCA | pmllorca@chu-clermontferrand.fr |
FRESH-PEF73248-en