{"doc_desc":{"title":"Registre \"Donn\u00e9es Informatis\u00e9es et VAlid\u00e9es en Transplantation\"","idno":"FRESH-PEF21204-fr","producers":[{"name":"Katy TREBERN-LAUNAY","affiliation":"NANTES UNIVERSITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF21204-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"21204"},{"agency":"FReSH","code":"FRESH-PEF21204"}]},"title":"Registre \"Donn\u00e9es Informatis\u00e9es et VAlid\u00e9es en Transplantation\"","alternate_title":"DIVAT"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Magali;GIRAL","PILabo":"Centre Hospitalier Universitaire H\u00f4tel Dieu \/ Institut de Transplantation Urologie N\u00e9phrologie, RTRS \u201cCentaure\u201d, UMR Inserm 1064Centre d'Investigation Clinique et de Bioth\u00e9rapie","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ORCID","uri":"0000-0001-7641-1592","role":"pi id"},{"title":"IdRef","uri":"121549828","role":"pi id"},{"title":"SIREN","uri":"264400136","role":"organisation id"},{"title":"RNSR","uri":"201220148C","role":"labo id"}],"email":"mgiral@chu-nantes.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Magali;GIRAL","email":"mgiral@chu-nantes.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05c1qsg97","role":"organisation id","title":"ROR"},{"uri":"264400136","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Transplantation"}],"topics":[{"topic":"N\u00e9phrologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3961e9d2-ab3b-451b-b246-20fc0ec3b0c4"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009398"}]}],"purpose":"Les huit centres du R\u00e9seau DIVAT ont \u00e9tabli entre eux un accord de Consortium afin de pouvoir dans le domaine de la transplantation d'organes recueillir et \u00e9changer des informations, initier et mener des \u00e9tudes \u00e9pid\u00e9miologiques ou des essais cliniques en commun, utiliser les r\u00e9sultats pour des publications destin\u00e9es \u00e0 la communaut\u00e9 scientifique ou pour d\u2019\u00e9ventuels partenariats avec l\u2019industrie pharmaceutique et cr\u00e9er une banque de donn\u00e9es biologiques li\u00e9es aux donn\u00e9es cliniques (pour 3 centres du R\u00e9seau).","abstract":"","coll_dates":[{"start":"1994-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Transplant\u00e9s r\u00e9naux et\\\/ou pancr\u00e9atiques\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques']","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\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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[10000-20000[ individus","response_rate":"11000"},"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":"La proc\u00e9dure de demande d\u2019extraction des donn\u00e9es de DIVAT sera prochainement disponible sur le site internet de DIVAT. La liste des variables disponibles dans la base est consultable sur le site internet de DIVAT.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"La base de donn\u00e9es DIVAT est ouverte \u00e0 tout demandeur souhaitant initier une \u00e9tude d'\u00e9pid\u00e9miologie clinique ou biologique autour de la transplantation."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"13-11-2014","lastUpdatedAuto":null,"lastUpdatedManual":"27-11-2014","isContributorPI":"Non","contributorName":"Magali GIRAL","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/PUBMED-DIVAT"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"Les donn\u00e9es sont collect\u00e9es en pr\u00e9-transplantation puis prospectivement en post-transplantation apr\u00e8s chaque visite de suivi des patients.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Nantes, Nancy, Montpellier, Toulouse, Necker (Paris), Lyon, Saint-Louis (Paris) et Nice"},"dataTypes":{"clinicalDataDetails":"En pr\u00e9-transplantation : donn\u00e9es d\u00e9mographiques, ant\u00e9c\u00e9dents et habitus du receveur, param\u00e8tres du greffon, param\u00e8tres du donneur et traitement \u00e0 la greffe.En post-transplantation : donn\u00e9es de l'examen clinique, \u00e9v\u00e9nements post-transplantation (complications, infections, rejets), traitement au cours du suivi, survie du greffon et du patient.","biologicalDataDetails":"En pr\u00e9-transplantation : statut viral, immunisation + pour les greffes pancr\u00e9atiques (peptide C, HbA1C, cr\u00e9atinine, prot\u00e9ines s\u00e9riques, albumin\u00e9mie, LDL, HDL, cholest\u00e9rol, triglyc\u00e9rides).En post-transplantation : cr\u00e9atinin\u00e9mie, prot\u00e9inurie, h\u00e9moglobine, LDL, triglyc\u00e9rides, immunisation + pour les greffes pancr\u00e9atiques (glyc\u00e9mie, peptide C, HbA1C, insuline, amylase, lipase, cholest\u00e9rol).","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}