French Cohort of People with Schizophrenia: Assessment of Different Stages of Illness Severity and Recovery

['Research will be regulated according to sponsor standard operating procedures. Research conducted at investigation centres and management of subjects will be in accordance with the Declaration of Helsinki and existing good practices. 9.1 Monitoring procedures. The CRA representing the sponsor shall conduct investigation centre visits scheduled according to the patient follow-up scheme in the protocol, at baseline within the various centres and at the designated research risk level. – Initiation visit at each centre: before enrolment of patient in study in order to implement the protocol and familiarisation with the various biomedical research stakeholders. – Case report forms will be reviewed by the CRA as the research advances during subsequent visits. The investigators undertake to receive the CRA at regular intervals. The following items will be reviewed during on-site visits and in accordance with good clinical practice: Adherence to defined research protocol and procedures; verification of patient informed consent; review of source documents and comparison with data recorded in the case report form for accuracy, missing data and data consistency according to the rules set forth by the Fondation FondaMental procedures. The accuracy and consistency of the data exclusively filled out in eCRFs by the expert centres are directly verified on the FACE BD database by a data manager. Checks will be carried out at several levels: Validation of online entry; consistency check of entries followed by a more complex consistency control procedure, generating requests issued by the clinician. Audit trail; back-up and archiving of databases will be automated. – Final visit: Recovery of clinical report form; verification of research documents; archiving; verification of sample transfer to the centralised laboratory. Data directly entered in the eCRF will be verified on the database and archived on the server in an automated manner. 9.2 Definition of collected clinical data. All data contained in the clinical report form or entered online by the clinician are entered in the database managed by the Fondation FondaMental. 9.3 Description of data circuit before online entry. 9.3.1 Data from the expert centre clinical report form. All phenotypic, clinical, biochemical and neuropsychological data will be collected systematically and either collected in a clinical report form in the subject expert centre and then entered in an online e-CRF (bioinformatics manager from the Fondation FondaMental) or entered directly online by the clinician. 9.3.2 Data from the specific module (§3.3.2.1). All data (environmental factors, health economics and quality of life) collected in the CIC will be reported in a specific form that will be sent to the coordinating expert centre and entered by a clinical research associate. 9.4 Electronic data entry. Database management and the generation of data files for conducting analyses will be carried out by the Fondation FondaMental IT team in accordance with the specifications sent by the coordinating centre. Data will either be collected through a web interface or sent directly to the Fondation FondaMental (for large-scale genotype files, for example). Clinical research forms will be completed by the clinician online or on paper, then followed-up and entered. Checks will be carried out at several levels: Validation of online entry; consistency check for entries followed by a more complex consistency control procedure; generating requests issued by the clinician. Audit trail; back-up and archiving of databases will be automated. All CRFs will be returned after being entered in the investigating departments. The generated variables (scale scores; sub-scores; variable combinations) will be dynamically published during analysis file creation. Electronic data on file will be declared to the CNIL. 9.5 Quality control by audit team. Studies may be audited by the sponsor at any time. The investigator and his/her team shall make themselves available during auditor visits, as well as allowing auditors access technical facilities, study material and patient records. Patient anonymity must be respected and information verified during these tests shall 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.']