{"doc_desc":{"title":"Registre des Malformations en Rh\u00f4ne Alpes","idno":"FRESH-PEF69-fr","producers":[{"name":"Emmanuelle AMAR","affiliation":"REGISTRE DES MALFORMATIONS EN RHONE ALPES (REMERA)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF69-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"69"},{"agency":"FReSH","code":"FRESH-PEF69"}]},"title":"Registre des Malformations en Rh\u00f4ne Alpes","alternate_title":"REMERA"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Emmanuelle;AMAR","PILabo":"REMERA et CHU DE LYON (HCL) \/ REMERA","affiliationName":"REGISTRE DES MALFORMATIONS EN RHONE ALPES (REMERA)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"253642779","role":"pi id"},{"title":"SIREN","uri":"494872328","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"emmanuelle.amar@remera.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"REGISTRE DES MALFORMATIONS EN RHONE ALPES (REMERA)","extlink":[{"title":"SIREN","uri":"494872328","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"REGION AUVERGNE RHONE ALPES","extlink":[{"title":"SIREN","uri":"200053767"}]},{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]},{"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 DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]}]},"distribution_statement":{"contact":[{"name":"Emmanuelle;AMAR","email":"emmanuelle.amar@remera.fr","type":"contact","affiliationName":"REGISTRE DES MALFORMATIONS EN RHONE ALPES (REMERA)","contactPointLabo":"","extlink":[{"uri":"494872328","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"pr\u00e9valence malformations cong\u00e9nitales"},{"keyword":"facteurs de risque reprotoxique"},{"keyword":"d\u00e9pistage ant\u00e9natal"},{"keyword":"IMG"},{"keyword":"base de donn\u00e9es malformations"},{"keyword":"\u00e9pid\u00e9miologie"},{"keyword":"surveillance"},{"keyword":"alerte"},{"keyword":"t\u00e9ratog\u00e8nes"},{"keyword":"g\u00e9n\u00e9tique"},{"keyword":"p\u00e9rinatalit\u00e9"}],"topics":[{"topic":"Gyn\u00e9cologie et obst\u00e9trique","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7de64596-5b0d-4977-8f98-b982ff2ec17d"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/284ca20c-beb4-4abe-99fa-ef4513358bad"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006176"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009774"}]},{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"Anenc\u00e9phalie ou anomalies similaires","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/458634958","title":"CIM-11"}]},{"topic":"Anomalies structurelles du d\u00e9veloppement de la paupi\u00e8re, de l'appareil lacrymal ou de l'orbite","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1284734679","title":"CIM-11"}]},{"topic":"Malformation cong\u00e9nitale du c\u0153ur ou des gros vaisseaux","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/2004408087","title":"CIM-11"}]},{"topic":"Anomalies du d\u00e9veloppement structurel du nez ou du cavum","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/484839707","title":"CIM-11"}]},{"topic":"Anomalies du d\u00e9veloppement","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/223744320","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectifs en terme de sant\u00e9 publique : 1) \u00c9valuation de l'importance et de l'\u00e9volution des malformations (incidence, facteurs, apparition d'une nouvelle malformation ou d'un nouveau sympt\u00f4me malformatif, variations spatio-temporelles de ces incidences) 2) \u00c9valuation des actions en sant\u00e9 publique: mesurer l'impact des actions mises en place, en particulier le d\u00e9pistage p\u00e9rinatal mais aussi les actions de pr\u00e9vention primaire sur la pr\u00e9valence des malformations et de proposer des orientations au d\u00e9veloppement des programme de sant\u00e9. 3) Alerte en cas de suspicion de lien avec un t\u00e9ratog\u00e8ne, connu ou non En terme de recherche: 1) Mise en \u00e9vidence des facteurs de risque de malformation 2) \u00c9tude de leurs interactions avec des susceptibilit\u00e9s d'ordre g\u00e9n\u00e9tique","abstract":"","coll_dates":[{"start":"1973-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes']","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            \"value\": \"Autre\",\n            \"concept\": {\n                \"vocab\": [],\n                \"vocabURI\": []\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\": \"Sont incluses dans le registre: Les malformations cong\u00e9nitales diagnostiqu\u00e9es en ant\u00e9natal ou en postnatal jusqu'\u00e0 la fin de la premi\u00e8re ann\u00e9e de vie.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es paracliniques (hors biologiques) : Anthropom\u00e9trie']","quality_statement":{"standards":[{"name":"['CIM 10']","committee":"","governance":""}],"other_quality_statement":"['Guide recueil, capture-recapture, croisements, s\u00e9lections al\u00e9atoiries de dossier']"}},"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"}]},"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\"}"],"research_instrument":"Acc\u00e8s libre","sources":[],"target_sample_size":">= 20000 individus","response_rate":"59000 par an\/per 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":"Acc\u00e8s aux donn\u00e9es (anonymis\u00e9es) possible, sur demande","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"Donn\u00e9es t\u00e9l\u00e9transmises quotidiennement pendant 4 mois depuis un collecteur GPRS portable."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"04-10-2017","isContributorPI":"Non","contributorName":"Emmanuelle AMAR","contributorAffiliation":"REGISTRE DES MALFORMATIONS EN RHONE ALPES (REMERA)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/tinyurl.com\/PUBMED-REMERA"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","","",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Non","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Collecte active: des enqu\u00eatrices se rendent dans les services et enregistrent dans leur base de donn\u00e9es, toutes les informations contenues dans les dossiers m\u00e9dicaux relatives aux malformations cong\u00e9nitales et leurs d\u00e9terminants","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"D\u00e9partement du Rh\u00f4ne, de l Is\u00e8re, de la Savoie, et de la Loire"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"triple test, caryotype, glyc\u00e9mie etc.","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}