指所有已簽署同意書並同意參與研究的受試者,包括後續經篩檢不符合資格者,以及在簽署同意後退出研究者。
All subjects who have consented to participate in the study, including those that did not qualify after screening and those that dropped out after consent.
中文釋義翻譯自英文釋義之資料來源。
1. Brandeis University. (n.d.). Glossary of Terms. In Human Research Protection Program. Retrieved August 25, 2025, from https://www.brandeis.edu/ora/hrpp/glossary.html
2. U.S. Food and Drug Administration (FDA). (2019). Guidance for industry: E6(R2) good clinical practice—Integrated addendum to ICH E6(R1). Silver Spring, MD: FDA. https://www.fda.gov/media/93884/download
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