{"doc_desc":{"title":"Registre des malformations cong\u00e9nitales en Bretagne (registre qualifi\u00e9 2015-2020)","idno":"FRESH-PEF7517-fr","producers":[{"name":"Florence ROUGET","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF7517-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"7517"},{"agency":"FReSH","code":"FRESH-PEF7517"}]},"title":"Registre des malformations cong\u00e9nitales en Bretagne (registre qualifi\u00e9 2015-2020)","alternate_title":""},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"type":"investigator","name":"Florence;ROUGET","PILabo":"CHU de Rennes","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"13186632X","role":"pi id"},{"title":"ROR","uri":"https:\/\/ror.org\/05qec5a53","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"florence.rouget@chu-rennes.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"Centre Hospitalier Universitaire de Rennes","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05qec5a53","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ARS BRETAGNE","extlink":[{"title":"SIREN","uri":"130007966"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]},{"name":"CONSEIL DEPARTEMENTAL","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Florence;ROUGET","email":"florence.rouget@chu-rennes.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05qec5a53","role":"organisation id","title":"ROR"}]}]},"study_info":{"keywords":[{"keyword":"Malformations cong\u00e9nitales"}],"topics":[{"topic":"Anomalies du d\u00e9veloppement","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/223744320","title":"CIM-11"}]},{"topic":"Malformations cong\u00e9nitales du syst\u00e8me nerveux","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/215057274","title":"CIM-11"}]},{"topic":"Maladies de l'appareil circulatoire","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/426429380","title":"CIM-11"}]},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"}],"purpose":"R\u00e9aliser une veille sanitaire, une surveillance des pr\u00e9valences dans le temps et dans l\u2019espace, une identification de facteurs t\u00e9ratog\u00e8nes. \u00c9tudier les facteurs environnementaux et proc\u00e9der aux analyses g\u00e9ospatiales de certaines malformations, en lien avec les activit\u00e9s avoisinantes.","abstract":"","coll_dates":[{"start":"2010-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Bretagne']","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\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Personnes en situation de handicap\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" enfants n\u00e9s vivants, ou sans vie \u00e0 un terme \u2265 22 SA et les interruptions de grossesse pour motif m\u00e9dical (IMG) quel que soit le terme - n\u00e9s \u00e0 partir du 1er septembre 2010 - porteurs d\u2019une malformation cong\u00e9nitale (crit\u00e8res Eurocat) diagnostiqu\u00e9e au cours de la premi\u00e8re ann\u00e9e de vie - m\u00e8re domicili\u00e9e en Bretagne\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","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"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":""}},"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":"1200 \/an \/year"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Registre de morbidit\u00e9"]}]},"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":"11-10-2013","lastUpdatedAuto":null,"lastUpdatedManual":"04-10-2018","isContributorPI":"Non","contributorName":"Florence ROUGET","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"---","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Bretagne: Ille et Vilaine, Finist\u00e8re, Morbihan et C\u00f4tes d'Armor (106 centres d\u00e9clarants)"},"dataTypes":{"clinicalDataDetails":"Examen p\u00e9diatrique.","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Non","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}