{"doc_desc":{"title":"Registry of Congenital Malformations in Brittany (qualified registry 2013-2015)","idno":"FRESH-PEF7517-en","producers":[{"name":"Florence ROUGET","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF7517-en","IDno":{"metadata_no":[{"agency":"PEF","code":"7517"},{"agency":"FReSH","code":"FRESH-PEF7517"}]},"title":"Registry of Congenital Malformations in Brittany (qualified registry 2013-2015)","alternate_title":""},"study_authorization":{"agency":[]},"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":"Yes"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"heart defects"},{"keyword":"diaphragmatic hernia"},{"keyword":"hypospadia"},{"keyword":"Spina bifida"}],"topics":[{"topic":"Developmental anomalies","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/223744320","title":"CIM-11"}]},{"topic":"Structural developmental anomalies of the nervous system","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/215057274","title":"CIM-11"}]},{"topic":"Diseases of the circulatory system","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/426429380","title":"CIM-11"}]},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"}],"purpose":"To carry out a health watch, monitor prevalency according to time and space and identify tetrogenic factors. To assess medical treatment requirements. To study environmental factors and begin a geospatial analyses for certain malformations in connection with surrounding activities.","abstract":"","coll_dates":[{"start":"2010-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Bretagne']","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    \"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\": \"Live births or foetal deaths with gestational age at \u226522 weeks and pregnancy terminations for medical reasons - born on or after 1st September 2010 - with congenital anomaly (EUROCAT criteria) diagnosed during the first year of life - mother living in Brittany.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity"}]},"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\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"700 \/an \/year"},"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":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","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":"11-10-2013","lastUpdatedAuto":null,"lastUpdatedManual":"04-10-2018","isContributorPI":"No","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":"Yes"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","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":"No"},"geographicalCoverage":{"geoDetail":"Brittany: Ille et Vilaine and C\u00f4tes d'Armor (106 registered centres)"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"No","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}