{"_buckets": {"deposit": "2b90eafd-f286-4295-9847-c0d8b0a76a41"}, "_deposit": {"created_by": 1, "id": "46505", "owners": [1], "pid": {"revision_id": 0, "type": "depid", "value": "46505"}, "status": "published"}, "_oai": {"id": "oai:repo.qst.go.jp:00046505", "sets": ["1"]}, "author_link": ["463424", "463426", "463425"], "item_8_biblio_info_7": {"attribute_name": "書誌情報", "attribute_value_mlt": [{"bibliographicIssueDates": {"bibliographicIssueDate": "2013-03", "bibliographicIssueDateType": "Issued"}, "bibliographicIssueNumber": "2", "bibliographicPageEnd": "434", "bibliographicPageStart": "419", "bibliographicVolumeNumber": "40", "bibliographic_titles": [{"bibliographic_title": "臨床評価"}]}]}, "item_8_description_5": {"attribute_name": "抄録", "attribute_value_mlt": [{"subitem_description": "Background:In Japan, GCP Ordinance was revised in 2008 to make research institutes which have an\nIRB (Institutional Review Board) possible to commit their review to an external IRB. The United States\n(US) Food and Drug Administration (FDA) issued in 2006 a guidance to facilitate Central IRB review. The\nEuropean Union (EU) issued in 2001 a Clinical Trial Directive to mandate member states to establish\nregulations by which multinational clinical trials can be initiated based on authorizations of one Ethics\nCommittee (EC) and one regulatory authority in one member state.\nObjectives:To find information on regulatory reformation and the actual situation towards facilitating\nutilization of cooperative or central IRB/EC after 2008.\nMethod:Literature survey and interview survey.\nFindings:The US government has proposed regulatory reformation to mandate one IRB review for one\nmulti-central clinical research. The EU has proposed regulatory reformation to make possible one EC\nreview in EU for multi-national clinical trials. In Korea and Taiwan, a cooperative review system has been\nfacilitated and quality improvement of IRB review and human subject protection system has been\nsimultaneously facilitated. In Japan, there is a finding of a survey that shows the utilization rate of\ncooperative IRB is approximately 30%. Actual utilization of cooperative/central IRB in the world has been\nsteadily increasing but not dramatically, and the above mentioned international situation is worth noting.", "subitem_description_type": "Abstract"}]}, "item_8_source_id_9": {"attribute_name": "ISSN", "attribute_value_mlt": [{"subitem_source_identifier": "0300-3051", "subitem_source_identifier_type": "ISSN"}]}, "item_access_right": {"attribute_name": "アクセス権", "attribute_value_mlt": [{"subitem_access_right": "metadata only access", "subitem_access_right_uri": "http://purl.org/coar/access_right/c_14cb"}]}, "item_creator": {"attribute_name": "著者", "attribute_type": "creator", "attribute_value_mlt": [{"creatorNames": [{"creatorName": "栗原, 千絵子"}], "nameIdentifiers": [{"nameIdentifier": "463424", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "景山, 茂"}], "nameIdentifiers": [{"nameIdentifier": "463425", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "栗原 千絵子", "creatorNameLang": "en"}], "nameIdentifiers": [{"nameIdentifier": "463426", "nameIdentifierScheme": "WEKO"}]}]}, "item_language": {"attribute_name": "言語", "attribute_value_mlt": [{"subitem_language": "jpn"}]}, "item_resource_type": {"attribute_name": "資源タイプ", "attribute_value_mlt": [{"resourcetype": "journal article", "resourceuri": "http://purl.org/coar/resource_type/c_6501"}]}, "item_title": "「共同IRB」をめぐる日米欧州アジアの状況", "item_titles": {"attribute_name": "タイトル", "attribute_value_mlt": [{"subitem_title": "「共同IRB」をめぐる日米欧州アジアの状況"}]}, "item_type_id": "8", "owner": "1", "path": ["1"], "permalink_uri": "https://repo.qst.go.jp/records/46505", "pubdate": {"attribute_name": "公開日", "attribute_value": "2013-03-19"}, "publish_date": "2013-03-19", "publish_status": "0", "recid": "46505", "relation": {}, "relation_version_is_last": true, "title": ["「共同IRB」をめぐる日米欧州アジアの状況"], "weko_shared_id": -1}