{"title":"用于医疗器械和诊断行业的CDISC SDTM模型","authors":"Carey G. Smoak","doi":"10.1179/175709208X334632","DOIUrl":null,"url":null,"abstract":"Abstract In May 2006, a CDISC SDTM Device sub-team was formed. This sub-team is made of industry experts, CDISC representatives and FDA representatives. This sub-team has been working on a model to fill-in the gaps in SDTM for medical device and diagnostic companies. The initial focus has been on developing a domain that would contain information (metadata) about devices and not on results from devices. The sub-team has come up with a model that is currently being reviewed by industry experts. The proposed model is based on a custom Finding Observation Class domain. The advantage of this proposed model is that it is simple and extensible.","PeriodicalId":253012,"journal":{"name":"Pharmaceutical Programming","volume":"5 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2008-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"6","resultStr":"{\"title\":\"A CDISC SDTM model for the medical device and diagnostic industry\",\"authors\":\"Carey G. Smoak\",\"doi\":\"10.1179/175709208X334632\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Abstract In May 2006, a CDISC SDTM Device sub-team was formed. This sub-team is made of industry experts, CDISC representatives and FDA representatives. This sub-team has been working on a model to fill-in the gaps in SDTM for medical device and diagnostic companies. The initial focus has been on developing a domain that would contain information (metadata) about devices and not on results from devices. The sub-team has come up with a model that is currently being reviewed by industry experts. The proposed model is based on a custom Finding Observation Class domain. The advantage of this proposed model is that it is simple and extensible.\",\"PeriodicalId\":253012,\"journal\":{\"name\":\"Pharmaceutical Programming\",\"volume\":\"5 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2008-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"6\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmaceutical Programming\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1179/175709208X334632\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceutical Programming","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1179/175709208X334632","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
A CDISC SDTM model for the medical device and diagnostic industry
Abstract In May 2006, a CDISC SDTM Device sub-team was formed. This sub-team is made of industry experts, CDISC representatives and FDA representatives. This sub-team has been working on a model to fill-in the gaps in SDTM for medical device and diagnostic companies. The initial focus has been on developing a domain that would contain information (metadata) about devices and not on results from devices. The sub-team has come up with a model that is currently being reviewed by industry experts. The proposed model is based on a custom Finding Observation Class domain. The advantage of this proposed model is that it is simple and extensible.
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