{"study_desc":{"title_statement":{"idno":"FRESH-PEF2388-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"2388"},{"agency":"FReSH","code":"FRESH-PEF2388"}]},"title":"Etude cas-t\u00e9moins sur le syndrome de Guillain-Barr\u00e9\/PGRx","alternate_title":""},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Lamiae;GRIMALDI-BENSOUDA","firstname":"Lamiae","lastname":"GRIMALDI-BENSOUDA","type":"investigator","extlink":[{"title":"SIREN","uri":"450195979","role":"organisation id"},{"uri":"0000-0003-1952-5467","role":"pi id","title":"ORCID"},{"uri":"077296125","role":"pi id","title":"IdRef"}],"email":"lamiae.grimaldi@aphp.fr","affiliationName":"L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH","PILabo":"","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH","extlink":[{"title":"SIREN","uri":"450195979","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH","extlink":[{"title":"SIREN","uri":"450195979"}]}]},"distribution_statement":{"contact":[{"name":"Lamiae;GRIMALDI-BENSOUDA","lastname":"GRIMALDI-BENSOUDA","firstname":"Lamiae","type":"contact","email":"lamiae.grimaldi@aphp.fr","affiliationName":"L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH","contactPointLabo":"","extlink":[{"uri":"450195979","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"pharmaco-\u00e9pid\u00e9miologie"}],"topics":[{"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":"Neurologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25 | http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"D009462"}]},{"topic":"Troubles dus \u00e0 la consommation d'alcool","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1676588433","title":"CIM-11"}]}],"purpose":"Surveillance et \u00e9valuation du risque de syndrome de Guillain-Barr\u00e9 associ\u00e9 \u00e0 l'exposition m\u00e9dicamenteuse ou vaccinale en situation r\u00e9elle de traitement.","abstract":"","coll_dates":[{"start":"2008-01-01"}],"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\":\"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D007231\"}},{\"value\":\"Nourrisson (28j \u00e0 2 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D007223\"}},{\"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\"}},{\"value\":\"Adulte (19 \u00e0 24 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adulte (25 \u00e0 44 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Adulte (45 \u00e0 64 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}},{\"value\":\"Grand \u00e2ge (80 ans et plus)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"Population g\u00e9n\u00e9rale\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Pour les cas : patients, homme et femme \u00e2g\u00e9s de 0 an et plus, ayant une polyradiculon\u00e9vrite aigu\u00eb d\u00e9clar\u00e9e par le neurologue, dont les premiers symptomes de l'\u00e9pisode remontent \u00e0 moins de 12 mois.  Pour les t\u00e9moins : patients, homme et femme \u00e2g\u00e9s de 0 an et plus, ayant consult\u00e9 un m\u00e9decin g\u00e9n\u00e9raliste.\",\"clusion_E\":\"\"}","data_kind":"['Donn\u00e9es cliniques','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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"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":"[10000-20000[ individus","response_rate":"234 cas\/cases 11125 r\u00e9f\u00e9rents\/controls"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Etude cas-t\u00e9moins"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}","notes":""},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"Import\u00e9e","creationDate":"09-03-2011","lastUpdatedManual":"10-07-2012","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":false,"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":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}