{"doc_desc":{"title":"Registre des malformations Cong\u00e9nitales d'Alsace (registre qualifi\u00e9 2011-2014)","idno":"FRESH-PEF62-fr","producers":[{"name":"Danaluiza TIMBOLSCHI","affiliation":"LES HOPITAUX UNIVERSITAIRES DE STRASBOURG (HUS)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF62-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"62"},{"agency":"FReSH","code":"FRESH-PEF62"}]},"title":"Registre des malformations Cong\u00e9nitales d'Alsace (registre qualifi\u00e9 2011-2014)","alternate_title":"REMACA"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Danaluiza;TIMBOLSCHI","PILabo":"CHRU Strasbourg","affiliationName":"LES HOPITAUX UNIVERSITAIRES DE STRASBOURG (HUS)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"266700574","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"danaluiza.timbolschi@chru-strasbourg.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"UNIVERSITE DE STRASBOURG","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg6eq24","role":"sponsor id"},{"title":"SIREN","uri":"130005457","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"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"}]}]},"distribution_statement":{"contact":[{"name":"Danaluiza;TIMBOLSCHI","email":"danaluiza.timbolschi@chru-strasbourg.fr","type":"contact","affiliationName":"LES HOPITAUX UNIVERSITAIRES DE STRASBOURG (HUS)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04bckew43","role":"organisation id","title":"ROR"},{"uri":"266700574","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"diagnostic pr\u00e9natal"}],"topics":[{"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 socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","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":"Sur le plan \u00e9pid\u00e9miologique: 1) La d\u00e9termination de la fr\u00e9quence (en terme de pr\u00e9valence) et la r\u00e9partition des malformations cong\u00e9nitales 2) L'identification des facteurs de risque des malformations (g\u00eane, environnement, m\u00e9dicaments et toxiques) 3) La d\u00e9termination de \"clusters\" malformatifs \u00e0 l'aide \u00e0 la d\u00e9cision en cas d'augmentation significative de la pr\u00e9valence d'un type de malformation (surveillance-alerte) 4) La mise \u00e0 disposition des donn\u00e9es pour des \u00e9tudes \u00e9pid\u00e9miologiques Sur le plan de la sant\u00e9 publique 1) L'\u00e9valuation de l'impact des politiques de sant\u00e9 dans le domaine de m\u00e9decine p\u00e9rinatale et l'impact des pratiques obst\u00e9tricales r\u00e9gionales 2) La mesure de l'efficacit\u00e9 de la pr\u00e9vention et la constitution d'un support pour l'information des professionnels de sant\u00e9 en particulier dans le domaine de la t\u00e9ratologie 3) L'\u00e9valuation des besoins sanitaires en m\u00e9decine p\u00e9rinatale (modes et lieux d'accouchement) Sur le plan clinique: 1) Le rep\u00e9rage de nouvelles associations malformatives voire l'identification de nouveaux sympt\u00f4mes 2) La d\u00e9termination de modes de transmission d'affections g\u00e9n\u00e9tiques 3) L'\u00e9tablissement des interactions entres les diff\u00e9rents partenaires actifs dans la pr\u00e9vention, la prise en charge socio-\u00e9ducative dans la r\u00e9gion concern\u00e9e","abstract":"","coll_dates":[{"start":"2005-01-01","end":"2004-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Grand Est']","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\": \"Cas notifi\u00e9s de malformations visibles \u00e0 l'examen clinique et visc\u00e9rales, ainsi que les syndromes malformatifs identifi\u00e9s ou non, y compris ceux li\u00e9s \u00e0 des anomalies chromosomiques jusqu'\u00e0 l'\u00e2ge de deux ans. Cas enregistr\u00e9s dans les deux d\u00e9partements d'Alsace et dont les parents sont domicili\u00e9s dans les deux d\u00e9partements d'Alsace uniquement\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"['CIM10 pour les malformations et les maladiescode ATC pour les m\u00e9dicaments']","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"}]},"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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s libre","sources":[],"target_sample_size":"[10000-20000[ individus","response_rate":"About 700 cases per year since 2005"},"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":"Donn\u00e9es individuelles : sur demande","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":"13-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-02-2012","isContributorPI":"Non","contributorName":"Danaluiza TIMBOLSCHI","contributorAffiliation":"LES HOPITAUX UNIVERSITAIRES DE STRASBOURG (HUS)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/PUBMED-RMCA"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":"Oui"},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Recueil actif aupr\u00e8s de l'ensemble des maternit\u00e9s publiques et priv\u00e9es d'Alsace, de l'ensemble des services de P\u00e9diatrie, Chirurgie Infantile, G\u00e9n\u00e9tique, Cardiop\u00e9diatrie, Neurochirurgie, Ophtalmologie, du Centre Pluridisciplinaire de Diagnostic Pr\u00e9natal, des laboratoires de cytog\u00e9n\u00e9tique et de foetopathologie","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Deux d\u00e9partements de la r\u00e9gions Alsace: le Bas-Rhin et le Haut-Rhin"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Cytog\u00e9n\u00e9tique, Biologie mol\u00e9culaire","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Non","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}