{"study_desc":{"title_statement":{"idno":"FRESH-PEF124-en","IDno":{"metadata_no":[{"agency":"PEF","code":"124"},{"agency":"FReSH","code":"FRESH-PEF124"}]},"title":"A cross-sectional, multicentre, epidemiological study of the drug management in hepatitis B","alternate_title":"Episurvey Hepatite B"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Bruno;BREGMAN","firstname":"Bruno","lastname":"BREGMAN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/013b57229","role":"organisation id"},{"title":"SIREN","uri":"380059956","role":"organisation id"}],"email":"bruno.bregman@bms.com","affiliationName":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","PILabo":"Bristol-Myers Squibb","isContact":true},{"name":"Nathalie;SCHMIDELY","firstname":"Nathalie","lastname":"SCHMIDELY","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/013b57229","role":"organisation id"},{"title":"SIREN","uri":"380059956","role":"organisation id"}],"email":"","affiliationName":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","PILabo":"Bristol-Myers Squibb","isContact":false}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/013b57229","role":"sponsor id"},{"title":"SIREN","uri":"380059956","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/013b57229"},{"title":"SIREN","uri":"380059956"}]}]},"distribution_statement":{"contact":[{"name":"Bruno;BREGMAN","lastname":"BREGMAN","firstname":"Bruno","type":"contact","email":"bruno.bregman@bms.com","affiliationName":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/013b57229","role":"organisation id","title":"ROR"},{"uri":"380059956","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Chronic hepatitis B"},{"keyword":"epidemiology"},{"keyword":"treatment"}],"topics":[{"topic":"Infectious disease medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"D055552"}]},{"topic":"Hepatology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/27c456a1-051a-42f6-b52a-3beff0487da7"}]},{"topic":"Chronic hepatitis B","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/352087872","title":"CIM-11"}]}],"purpose":"Describe the drug management of patients having chronic hepatitis B, in France, in 2006.","abstract":"","coll_dates":[{"start":"2006-01-01","end":"2006-12-31"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Young Adult (19 to 24 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adult (25 to 44 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Middle Aged (45 to 64 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Aged (65 to 79 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}},{\"value\":\"Aged, 80 and over (80 years and more)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"General population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"M\/F >=18 years, infected by the hepatitis B virus for at least 6 months, seen in outpatient clinic visit at expert centers for caring of hepatitis (Hepatitis Referenced University Hospitals, General Hospital Centres, community-based hepato-gastroenterologists) between 1 Jan. and 31 March 2006.\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Biological 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":"One-time cross-sectional study","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Probability.Cluster\",\"vocab\":\"CESSDA\"},\"value\":\"Probability: Cluster\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1800"},"method_notes":"Observational Study","study_class":"Completed study","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}","notes":""},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"31-01-2011","lastUpdatedManual":"05-09-2017","isContributorPI":"","contributorName":"Bruno BREGMAN","contributorAffiliation":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industry"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Case report form","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Metropolitan France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"ALT, HBe status, viral load","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}