定義與規範內容包括臨床試驗的設計、執行、紀錄與報告所應遵循的倫理與科學品質標準，特別保障受試者的權利、安全與福祉。

A standard for the design, conduct, performance, monitoring, auditing, recording,analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights,integrity, and confidentiality of trial subjects are protected.

衛生福利部. (2020 年 8 月 28 日). 藥品優良臨床試驗作業準則（Good Clinical Practice, GCP）. 全國法規資料庫. https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=L0030056

1. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, & Center for Biologics Evaluation and Research. (2018, March). E6(R2) good clinical  practice: Integrated addendum to ICH E6(R1): Guidance for industry. Silver Spring, MD: FDA. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs

2. European Medicines Agency (EMA). (2016). ICH guideline for good clinical  practice E6(R2). Amsterdam: EMA. https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice

• 原則上「單字中英文釋義」欄位的內容皆採用原文引用（即未經改寫），僅少部分內容有經微幅文字編輯。若欲對釋義內容有更深入的瞭解，敬請參考「資料來源」欄位所提供之原始出處的完整內容。
• 資料來源無編號：代表釋義內容出自同一筆來源。
• 資料來源有項目符號：代表釋義內容是引用多筆來源合寫而成。
• 資料來源有編號：代表該來源是相同編號之釋義內容的原始出處。