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E6(R1) (MLHW Step 5)E6(R1) (ICH Step 4)

臨床評価 24巻 別冊 1996

ICH Harmonised Tripartite Guideline

Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 1 May 1996, this guideline is recommended for adoption to the three regulatory parties to ICH (This document includes the Post Step 4 corrections agreed by the Steering Committee on 10 June 1996)








Guideline for Good Clinical Practice


Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO).

This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.

The principles established in this guideline may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects.


1.1 副作用 

承認前の新医薬品又は新用途での臨床経験(従って臨床用量が定まっていない場合) については以下の通り:






1.1 Adverse Drug Reaction (ADR)

In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out.

Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.2 有害事象 



1.2 Adverse Event (AE)

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.3 改訂(治験実施計画書の)


1.3 Amendment (to the protocol)

See Protocol Amendment.

1.4 適用される規制要件 


1.4 Applicable Regulatory Requirement(s)

Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.

1.5 承認(治験審査委員会の)


1.5 Approval (in relation to Institutional Review Boards)

The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.

1.6 監査 


1.6 Audit

A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

1.7 監査証明書 


1.7 Audit Certificate

A declaration of confirmation by the auditor that an audit has taken place.

1.8 監査報告書 


1.8 Audit Report

A written evaluation by the sponsor’s auditor of the results of the audit.

1.9 監査証跡 


1.9 Audit Trail

Documentation that allows reconstruction of the course of events.

1.10 盲検化/遮蔽化 


1.10 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).

1.11 症例報告書 


1.11 Case Report Form (CRF)

A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

1.12 臨床試験(治験)


1.12 Clinical Trial/Study

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.

1.13 治験の総括報告書 


1.13 Clinical Trial/Study Report

A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study Reports).

1.14 対照薬 


1.14 Comparator (Product)

An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.

1.15 遵守(治験に関する)


1.15 Compliance (in relation to trials)

Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.

1.16 秘密の保全 


1.16 Confidentiality

Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.

1.17 契約書


1.17 Contract

A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.

1.18 治験調整委員会 


1.18 Coordinating Committee

A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.

1.19 治験調整医師


1.19 Coordinating Investigator

An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.

1.20 開発業務受託機関


1.20 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.

1.21 直接閲覧 


1.21 Direct Access

Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor’s monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects’ identities and sponsor’s proprietary information.

1.22 証拠資料 


1.22 Documentation

All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

1.23 必須文書 


1.23 Essential Documents

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see 8. Essential Documents for the Conduct of a Clinical Trial).

1.24 医薬品の臨床試験の実施に関する基準


1.24 Good Clinical Practice (GCP)

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.

1.25 独立データモニタリング委員会(IDMC)(効果・安全性モニタリング委員会、モニタリング委員会、データモニタリング委員会)


1.25 Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)

An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.

1.26 公正な立会人 


1.26 Impartial Witness

A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.

1.27 独立倫理委員会

医学・科学の専門家及び医学・科学の非専門家によって構成される独立の(医療機関内、地域的、国単位又は複数国にまたがる)委員会。当委員会の責務は被験者の人権、安全及び福祉の保護を保証することであり、特に治験実施計画書、治験責任医師の適格性、施設、並びに被験者から文書によるインフォームド・コンセントを得るのに使用される方法及び 資料を審査し、承認することによって、かかる保護に公の保証を与えることである。


1.27 Independent Ethics Committee (IEC)

An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline.

1.28 インフォームド・コンセント


1.28 Informed Consent

A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.

1.29 査察 


1.29 Inspection

The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).

1.30 治験実施医療機関 


1.30 Institution (medical)

Any public or private entity or agency or medical or dental facility where clinical trials are conducted.

1.31 治験審査委員会 


1.31 Institutional Review Board (IRB)

An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

1.32 治験の中間報告書 


1.32 Interim Clinical Trial/Study Report

A report of intermediate results and their evaluation based on analyses performed during the course of a trial.

1.33 治験薬 


1.33 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.

1.34 治験責任医師 Investigator

治験実施施設において治験の実施に関して責任を有する医師又は歯科医師。治験実施施設において、治験が複数の者から成るチームにより実施される場合には、治験責任医師は当該チームの責任者たるリーダーであり、首席治験医師 (principal investigator)と呼ばれることがある。『治験補助医師 (Subinvestigator)』を参照。

1.34 Investigator

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Subinvestigator.

1.35 治験責任医師/治験実施医療機関 


1.35 Investigator / Institution

An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”.

1.36 (治験責任医師用)治験薬概要書


1.36 Investigator’s Brochure

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 (see 7. Investigator’s Brochure).

1.37 法定代理人等


1.37 Legally Acceptable Representative

An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial.

1.38 モニタリング 


1.38 Monitoring

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

1.39 モニタリング報告書 


1.39 Monitoring Report

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.

1.40 多施設共同治験


1.40 Multicentre Trial

A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.

1.41 非臨床試験 


1.41 Nonclinical Study

Biomedical studies not performed on human subjects.

1.42 意見(独立倫理委員会の)


1.42 Opinion (in relation to Independent Ethics Committee)

The judgement and/or the advice provided by an Independent Ethics Committee (IEC).

1.43 原医療記録

『原資料 (Source Documents)』を参照。

1.43 Original Medical Record

See Source Documents.

1.44 治験実施計画書


1.44 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. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.

1.45 治験実施計画書の改訂 


1.45 Protocol Amendment

A written description of a change(s) to or formal clarification of a protocol.

1.46 治験の品質保証


1.46 Quality Assurance (QA)

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

1.47 治験の品質管理 

治験関連の活動の質に求められる要件を充足していることを検証するために、治験の品質保証システム(Quality Assurance System)の一環として行われる実務的な手法及び活動。

1.47 Quality Control (QC)

The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.

1.48 無作為化


1.48 Randomization

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

1.49 規制当局 

規制を行う権限を有する機関。本ガイドラインでは、「規制当局」は、提出された治験データを審査する当局及び査察を実施する当局を含む(1.29参照)。またこれらの機関は「管轄当局(competent authorities)」として記される場合もある。

1.49 Regulatory Authorities

Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities.

1.50 重篤な有害事象又は重篤な副作用 








1.50 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)

Any untoward medical occurrence that at any dose:

– results in death,

– is life-threatening,

– requires inpatient hospitalization or prolongation of existing hospitalization,

– results in persistent or significant disability/incapacity,


– is a congenital anomaly/birth defect

(see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.51 原データ 

治験における臨床所見、観察、その他の活動に関する元の記録又はその保証付き複写 に記録されているあらゆる情報で、治験の再現と評価に必要なもの。


1.51 Source Data

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).