Regulations for Good Clinical Practice Article 3
Terms used in this Regulations are defined as follows:1.Clinical Trial: Any investigation in human subjects intended to discover or verify the clinical, pharmacological or other pharmaceutical effects of an investigational product(s).2.Nonclinical Study: Biomedical studies not performed on human subjects.3.Subject/Trial Subject: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.4.Informed Consent Form: A written documentation signed and dated by a subject who voluntarily confirms his or her willingness to participate in a particular trial, after having been informed and understand all aspects of the trial that are relevant to the subject's decision to participate.5.Ethics Committee/ Institutional Review Board (IRB): An independent committee constituted of medical professionals and impartial persons with no medical professions, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial.6.Institution/Trial Site: A medical institution where clinical trials are conducted.7.Investigator: A person responsible for the conduct of the clinical trial at a trial site.8.Sponsor: An individual, company, institution, or organization which takes responsibility for the initiation and management of a clinical trial.9.Contract Research Organization (CRO): A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.10.Investigational Product: A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.11.Protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.12.Investigator's Brochure (IB): A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects.13.Adverse Drug Reaction (ADR): All noxious and unexpected response to a medicinal product. An adverse drug reaction should be reasonably related to the use of the investigational product(s).14.Adverse Event (AE): Any untoward medical occurrence in a clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with the use of the investigational product(s).15.Blinding/Masking: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).
中文原文 藥品優良臨床試驗作業準則第3條
本準則專用名詞定義如下：
一、臨床試驗：以發現或證明藥品在臨床、藥理或其他藥學上之作用為目的，而於人體執行之研究。
二、非臨床試驗：非於人體執行之生物醫學研究。
三、受試者：參加臨床試驗而接受試驗藥品或對照藥品之個人。
四、受試者同意書：受試者於受告知並了解將參與之臨床試驗之相關訊息，且參酌是否參與試驗之所有因素後，自願簽署願意參加試驗之文件。
五、人體試驗委員會：由具醫學背景之專業人員與非醫學背景之社會公正人士所共同組成之委員會，其責任在保護受試者之權利、安全與福祉。
六、試驗機構：執行臨床試驗之醫療機構。
七、試驗主持人：試驗機構執行臨床試驗之負責人。
八、試驗委託者：臨床試驗之發起及管理者。
九、受託研究機構：和試驗委託者締約以承擔臨床試驗一部或全部工作之個人或機構。
十、試驗藥品：臨床試驗中用來試驗之藥品，或當做參考之活性成分製劑或安慰劑。
包括已上巿藥品使用於與其核准內容不同之用途、配方、包裝、適應症，或用於獲得有關核准用途之進一步資料。
十一、試驗計畫書：記載臨床試驗之目的、設計、方法、統計考量與編制等事項之文件，並得載明試驗之相關背景及理論。
十二、主持人手冊：有關試驗藥品之臨床及非臨床數據之編輯物。
十三、藥品不良反應：使用藥品後所發生之有害且未預期之反應。
此項反應與試驗藥品間，應具有合理之因果關係。
十四、不良事件：受試者參加試驗後所發生之任何不良情況。
此項不良情況與試驗藥品間不以具有因果關係為必要。
十五、盲性：使參與試驗之一方或多方不知試驗治療分配之方式。
單盲係指受試者不知治療分配之方式，雙盲是指受試者、試驗主持人、監測者，及在某些情況下，數據分析者亦不清楚治療分配之方式。
一、臨床試驗：以發現或證明藥品在臨床、藥理或其他藥學上之作用為目的，而於人體執行之研究。
二、非臨床試驗：非於人體執行之生物醫學研究。
三、受試者：參加臨床試驗而接受試驗藥品或對照藥品之個人。
四、受試者同意書：受試者於受告知並了解將參與之臨床試驗之相關訊息，且參酌是否參與試驗之所有因素後，自願簽署願意參加試驗之文件。
五、人體試驗委員會：由具醫學背景之專業人員與非醫學背景之社會公正人士所共同組成之委員會，其責任在保護受試者之權利、安全與福祉。
六、試驗機構：執行臨床試驗之醫療機構。
七、試驗主持人：試驗機構執行臨床試驗之負責人。
八、試驗委託者：臨床試驗之發起及管理者。
九、受託研究機構：和試驗委託者締約以承擔臨床試驗一部或全部工作之個人或機構。
十、試驗藥品：臨床試驗中用來試驗之藥品，或當做參考之活性成分製劑或安慰劑。
包括已上巿藥品使用於與其核准內容不同之用途、配方、包裝、適應症，或用於獲得有關核准用途之進一步資料。
十一、試驗計畫書：記載臨床試驗之目的、設計、方法、統計考量與編制等事項之文件，並得載明試驗之相關背景及理論。
十二、主持人手冊：有關試驗藥品之臨床及非臨床數據之編輯物。
十三、藥品不良反應：使用藥品後所發生之有害且未預期之反應。
此項反應與試驗藥品間，應具有合理之因果關係。
十四、不良事件：受試者參加試驗後所發生之任何不良情況。
此項不良情況與試驗藥品間不以具有因果關係為必要。
十五、盲性：使參與試驗之一方或多方不知試驗治療分配之方式。
單盲係指受試者不知治療分配之方式，雙盲是指受試者、試驗主持人、監測者，及在某些情況下，數據分析者亦不清楚治療分配之方式。