Transcription of ) JSCTR GCP (2018 年4月修正
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) JSCTR GCP (2018 年4月修正
JSCTR GCP ( ) JSCTR GCP (2018 8 ) 1 J-GCP J-GCP 2 3 Institution Investigator (Sponsor Certified Copy CRO:Contract ResearchOrganization SMO Site ManagementOrganization IRB IEC JSCTR GCP SOP:Standard Operating Procedure ADR Adverse Drug Reaction SAE SeriousAdverse Events)
4 項目 内容 10．ich-gcp ・ich とは ・ich の目的 ・ich-gcp の内容 ・j-gcp、統合指針との相違点 11．「人を対象とする医学研究に関す
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