{"doc_desc":{"title":"Etude transversale sur le d\u00e9tection des \u00e9v\u00e8nements ind\u00e9sirables graves au d\u00e9cours d\u2019une chimioth\u00e9rapie","idno":"FRESH-PEF33496-fr","producers":[{"name":"Marie-Christine PERAULT-POCHAT","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF33496-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"33496"},{"agency":"FReSH","code":"FRESH-PEF33496"}]},"title":"Etude transversale sur le d\u00e9tection des \u00e9v\u00e8nements ind\u00e9sirables graves au d\u00e9cours d\u2019une chimioth\u00e9rapie","alternate_title":"SIRCADE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Marie-Christine;PERAULT-POCHAT","firstname":"Marie-Christine","lastname":"PERAULT-POCHAT","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/029s6hd13","role":"organisation id"},{"title":"SIREN","uri":"200055358","role":"organisation id"}],"email":"marie-christine.perault@chu-poitiers.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS","PILabo":"CHU of \/ CIC1402 CIC Poitiers Team\/activity: Multi-subject unit U1084 Experimental and clinical neuroscience laboratory Team\/activity: Neurobiology and neuropharmacology of dependence","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/029s6hd13","role":"sponsor id"},{"title":"SIREN","uri":"200055358","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01g80gk13"},{"title":"SIREN","uri":"180036113"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]}]},"distribution_statement":{"contact":[{"name":"Marie-Christine;PERAULT-POCHAT","lastname":"PERAULT-POCHAT","firstname":"Marie-Christine","type":"contact","email":"marie-christine.perault@chu-poitiers.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/029s6hd13","role":"organisation id","title":"ROR"},{"uri":"200055358","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"\u00c9tude qualitative"},{"keyword":"socio-anthropologique"},{"keyword":"\u00e9v\u00e8nement ind\u00e9sirable grave"}],"topics":[{"topic":"Oncologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"\u00c9valuer l\u2019incidence des \u00e9v\u00e8nements ind\u00e9sirables graves (EIG) cons\u00e9cutifs \u00e0 une chimioth\u00e9rapie et comprendre les obstacles \u00e0 la sous-notification des \u00e9v\u00e8nements ind\u00e9sirables graves par les professionnels de sant\u00e9.","abstract":"","coll_dates":[{"start":"2008-01-01"}],"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\": 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           \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\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\": \"Tous les cas de tumeurs malignes invasives (h\u00e9mopathies malignes et tumeurs solides en-dehors des carcinomes baso-cellulaires de la peau), les tumeurs in situ, les tumeurs borderline des ovaires, et les tumeurs b\u00e9nignes ou d\u2019\u00e9volution impr\u00e9visible du cerveau et de la vessie. Les ad\u00e9nomes avanc\u00e9s colorectaux font l\u2019objet d\u2019un enregistrement passif.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Qualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","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\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"1000"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"05-03-2015","lastUpdatedAuto":null,"lastUpdatedManual":"12-09-2017","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Recherche dans le dossier m\u00e9dical du patient les \u00e9v\u00e8nements susceptibles d\u2019\u00eatre des \u00e9v\u00e8nements ind\u00e9sirables graves (d\u00e9finis selon la directive europ\u00e9enne de 2010) sur une p\u00e9riode de 6 mois apr\u00e8s l\u2019initiation d\u2019une chimioth\u00e9rapie \u00b1 radioth\u00e9rapie.Enqu\u00eate aupr\u00e8s des professionnels de sant\u00e9 et des patients.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"R\u00e9gion Poitou-Charentes, soit quatre d\u00e9partements : 16 Charente, 17 Charente-Maritime, 79 Deux-S\u00e8vres et 86 Vienne"},"dataTypes":{"clinicalDataDetails":"- Socio-d\u00e9mographiques : sexe, \u00e2ge, mode de vie, niveau socioprofessionnel...- Morbidit\u00e9 : date et nature du diagnostic, poids, taille...- M\u00e9dicaments : nom, posologie, date de d\u00e9but et fin de traitement...- Lignes de traitement : 1\u00e8reintention, n\u00e9o-adjuvante- EIG identifi\u00e9s : date d\u2019apparition, signes cliniques et biologiques, \u00e9volution...","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}