{"study_desc":{"title_statement":{"idno":"FRESH-PEF2526-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"2526"},{"agency":"FReSH","code":"FRESH-PEF2526"}]},"title":"Etude longitudinale sur l'observance globale et de la dur\u00e9e de traitement par ZOMACTON\u00ae avec le stylo transjecteur ZOMAJET\u00ae","alternate_title":"ZOMAJET"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Farah;BAHBAH","firstname":"Farah","lastname":"BAHBAH","type":"investigator","extlink":[{"title":"SIREN","uri":"322624735","role":"organisation id"}],"email":"Farah.Bahbah@ferring.com","affiliationName":"FERRING SAS","PILabo":"FERRING","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"FERRING SAS","extlink":[{"title":"SIREN","uri":"322624735","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"FERRING SAS","extlink":[{"title":"SIREN","uri":"322624735"}]}]},"distribution_statement":{"contact":[{"name":"Farah;BAHBAH","lastname":"BAHBAH","firstname":"Farah","type":"contact","email":"Farah.Bahbah@ferring.com","affiliationName":"FERRING SAS","contactPointLabo":"","extlink":[{"uri":"322624735","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Somatropine"},{"keyword":"zomacton"},{"keyword":"zomajet vision X"},{"keyword":"Zomajet 2 vision"}],"topics":[{"topic":"Endocrinologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"D004704"}]},{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"D010372"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"\u00c9valuer avec une pr\u00e9cision suffisante le taux d\u2019observance globale au traitement sur une p\u00e9riode maximale de trois ans. L'\u00e9tude est r\u00e9alis\u00e9e \u00e0 la demande des autorit\u00e9s.","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Masculin\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"F\u00e9minin\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Petite enfance (2 \u00e0 5 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D002675\"}},{\"value\":\"Enfance (6 \u00e0 12 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D002648\"}},{\"value\":\"Adolescence (13 \u00e0 18 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000293\"}}],\"level_type_clusion_I\":\"Patients\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Tous les patients, r\u00e9pondant aux crit\u00e8res de la Fiche d\u2019Information Th\u00e9rapeutique (d\u00e9ficit en hormone de croissance ou syndrome de Turner), pour lesquels est initi\u00e9 un traitement par Zomacton\u00ae 4 mg avec le stylo transjecteur Zomajet\u00ae 2 Vision ou par Zomacton\u00ae 10 mg avec le stylo transjecteur  Zomajet\u00ae Vision X lorsque ce dernier aura re\u00e7u son Autorisation de Mise sur le March\u00e9.\",\"clusion_E\":\"\"}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques (hors biologiques)','Donn\u00e9es paracliniques (hors biologiques) : Anthropom\u00e9trie','Donn\u00e9es biologiques','Donn\u00e9es de sant\u00e9 rapport\u00e9es par les participants de l'\u00e9tude']","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\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":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"90"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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\"}]}","notes":""},"dataset_use":{"restrictions":"","conditions":"Pour toute demande d'information sur l'\u00e9tude ZOMAJET, merci de contacter : Dr Mustapha-Kamal BENGUERBA","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"Import\u00e9e","creationDate":"29-03-2011","lastUpdatedManual":"27-03-2012","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Questionnaire \u00e0 l\u2019initiation du traitement (visite d\u2019initiation) : Identification du questionnaire ; date de visite ; crit\u00e8re d\u2019inclusion (Fiche d\u2019Information Th\u00e9rapeutique Initiale) ; donn\u00e9es patient : sexe, date de naissance, taille, poids, \u00e2ge osseux (selon l\u2019atlas de Greulich et Pyle), gain de taille avant traitement, stade pubertaire (selon Tanner), ant\u00e9c\u00e9dents ; indication (d\u00e9ficit en GH ou syndrome de Turner avec caryotype), cause du d\u00e9ficit en GH, exploration du d\u00e9ficit en GH (IGF-1 si disponible, tests de stimulation et r\u00e9sultats, perturbations hormonales ou endocriniennes associ\u00e9es) ; Traitement prescrit ; Posologie et modalit\u00e9s d\u2019administration.Questionnaires de suivi (1 visite de suivi environ tous les 3 \u00e0 6 mois) : Identification du questionnaire ; date de visite ; taille, poids, \u00e2ge osseux, stade pubertaire, glyc\u00e9mie \u00e0 jeun et IGF-1 (si disponibles) ; Traitement administr\u00e9 comme prescrit (oui\/non) - si non, traitement administr\u00e9 par intermittence, arr\u00eat du traitement et motif(s) d\u2019inobservance ; Traitement arr\u00eat\u00e9 par le m\u00e9decin (oui\/non) - si oui, date et motif(s) - si non, difficult\u00e9s techniques d\u2019utilisation du stylo (oui\/non) ; modification des modalit\u00e9s d\u2019administration (oui\/non) : nouveau dosage et\/ou nouvelle posologie et\/ou nouvelle t\u00eate du stylo transjecteur et motif(s). Tol\u00e9rance locale et g\u00e9n\u00e9rale.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"National"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"IGF-1 si disponible","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}