{"doc_desc":{"title":"Etude longitudinale sur des patients atteints d'h\u00e9patite chronique C : \u00e9tude de l'utilisation de Pegasys\u00ae en milieu hospitalier et lib\u00e9ra","idno":"FRESH-PEF177-fr","producers":[{"name":"Alexandrina PINTA","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF177-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"177"},{"agency":"FReSH","code":"FRESH-PEF177"}]},"title":"Etude longitudinale sur des patients atteints d'h\u00e9patite chronique C : \u00e9tude de l'utilisation de Pegasys\u00ae en milieu hospitalier et lib\u00e9ra","alternate_title":"HEPATYS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Alexandrina;PINTA","firstname":"Alexandrina","lastname":"PINTA","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01mqmer16","role":"organisation id"},{"title":"SIREN","uri":"775752140","role":"organisation id"}],"email":"alexandrina.pinta@roche.com","affiliationName":"F. HOFFMANN-LA ROCHE AG","PILabo":"ROCHE","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140"}]}]},"distribution_statement":{"contact":[{"name":"Alexandrina;PINTA","lastname":"PINTA","firstname":"Alexandrina","type":"contact","email":"alexandrina.pinta@roche.com","affiliationName":"F. HOFFMANN-LA ROCHE AG","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01mqmer16","role":"organisation id","title":"ROR"},{"uri":"775752140","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"h\u00e9patite chronique C"},{"keyword":"Pegasys"}],"topics":[{"topic":"H\u00e9patologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/27c456a1-051a-42f6-b52a-3beff0487da7"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"D\u00e9crire l'utilisation de Pegasys en \"situation r\u00e9elle\", chez des patients atteint d'h\u00e9patite chronique 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{\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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients atteints d'h\u00e9patite chronique C pour lesquels un traitement par Pagasys a \u00e9t\u00e9 d\u00e9cid\u00e9 puis initi\u00e9, suivis en milieu 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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":"[1000-10000[ individus","response_rate":"2155"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s 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