{"doc_desc":{"title":"Rh\u00f4ne Alpes birth defects registry","idno":"FRESH-PEF69-en","producers":[{"name":"Emmanuelle AMAR","affiliation":"REGISTRE DES MALFORMATIONS EN RHONE ALPES (REMERA)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF69-en","IDno":{"metadata_no":[{"agency":"PEF","code":"69"},{"agency":"FReSH","code":"FRESH-PEF69"}]},"title":"Rh\u00f4ne Alpes birth defects registry","alternate_title":"REMERA"},"study_authorization":{"agency":[]},"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":"Yes"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"prevalence of congenital malformations"},{"keyword":"reprotoxic risk factors"},{"keyword":"antenatal screening"},{"keyword":"eugenic abortions"},{"keyword":"perinatality"},{"keyword":"database on malformations"},{"keyword":"epidemiology"},{"keyword":"follow-up"},{"keyword":"alert"},{"keyword":"teratogens"},{"keyword":"genetics"}],"topics":[{"topic":"Gynaecology and obstetrics","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":"Paediatrics","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":"Anencephaly or similar anomalies","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/458634958","title":"CIM-11"}]},{"topic":"Structural developmental anomalies of eyelid, lacrimal apparatus or orbit","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1284734679","title":"CIM-11"}]},{"topic":"Structural developmental anomaly of heart or great vessels","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/2004408087","title":"CIM-11"}]},{"topic":"Structural developmental anomalies of the nose or cavum","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/484839707","title":"CIM-11"}]},{"topic":"Developmental anomalies","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/223744320","title":"CIM-11"}]},{"topic":"Behavioral determinants: Addiction","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Objectives in terms of public health: 1) Evaluation of the importance of the change in malformations (incidence, factors, appearance of a new malformation or of a new malformation symptom, space-time variations of these incidences) 2) Evaluation of the actions in public health: measure the impact of the actions implemented, especially perinatal screening and also the primary prevention initiatives on the prevalence of malformations and propose orientations for the development of health programs. 3) Alert in the case where a link with a teratogen, whether or not known, is suspected In terms of research: 1) Highlight the factors of risk of malformation 2) Study their interactions with susceptibilities of a genetic nature","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        },\n        {\n            \"value\": \"Other\",\n            \"concept\": {\n                \"vocab\": [],\n                \"vocabURI\": []\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Infant, Newborn (birth to 28 days)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Infant (28 days to 2 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"People with disabilities\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"The following are included in the registry: Congenital malformations diagnosed antenatally or postnatally until the end of the first year of life.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data','Paraclinical data (non-biological) : Anthropometry']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":""}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Free access","sources":[],"target_sample_size":">= 20000 individuals","response_rate":"61 000 (in 2012)"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Morbidity registry"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"Data depersonalized","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Access to the data (depersonalized) is possible, on request","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"04-10-2017","isContributorPI":"No","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":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"No","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Active collection: survey takers go to the departments and record in their databases all of the information contained in the medical dossiers concerning congenital malformations and their determinants","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"D\u00e9partement of Rh\u00f4ne, Is\u00e8re, Savoie, and Loire"},"dataTypes":{"clinicalDataDetails":"Medical and neurological history; screening for motor and parkinsonian disorders; subjective cognitive complaints; complete neuropsychological balance: battery of cognitive tests (clinical: MMSE, IST, FCSRT; 4 CANTAB (Alzheimer) computer battery tests; CDR-SOB; clinical impression; depression and anxiety scales, etc.","biologicalDataDetails":"triple test, karyotype, glycemia","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}