{"doc_desc":{"title":"Observatoire des premi\u00e8res pouss\u00e9es survenant sous le premier traitement immunomodulateur (IMD) chez des patients souffrant de SEP-RR","idno":"FRESH-PEF92-fr","producers":[{"name":"Franck VIGNAL","affiliation":"SANOFI (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF92-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"92"},{"agency":"FReSH","code":"FRESH-PEF92"}]},"title":"Observatoire des premi\u00e8res pouss\u00e9es survenant sous le premier traitement immunomodulateur (IMD) chez des patients souffrant de SEP-RR","alternate_title":"OPISEP"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Franck;VIGNAL","PILabo":"Sanofi Aventis","affiliationName":"SANOFI (FRANCE)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"395030844","role":"organisation id"},{"title":"","uri":"","role":"labo 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pouss\u00e9e sous traitement IMD"}],"topics":[{"topic":"Neurologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"Scl\u00e9rose en plaques r\u00e9mittente-r\u00e9currente","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/799053936","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"D\u00e9crire les profils de patients souffrant de SEP-RR en fonction du d\u00e9lai d\u2019apparition de la premi\u00e8re pouss\u00e9e apr\u00e8s mise en route du premier traitement immunomodulateur.","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"\u2022Patient majeur (\u2265 18 ans) \u2022Patient souffrant de SEP-RR \u2022Patient pr\u00e9sentant, apr\u00e8s mise en route du premier traitement immunomodulateur, une premi\u00e8re pouss\u00e9e r\u00e9cente (moins de 10 jours)  \u2022Patient acceptant de participer \u00e0 l\u2019\u00e9tude \",\n    \"clusion_E\": \"\u2022Patient participant \u00e0 une recherche clinique (pr\u00e9-AMM)\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nAutres"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"Less than 500 individuals"},"method_notes":"Etude 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