ICH GCP_en

Question 1

ICH

Answer 1

=International Conference of Harmonisation

Question 2

GCP

Answer 2

=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.

Question 3

GCP = Good Clinical Practice

Answer 3

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.

Question 4

regulatory authorities

Answer 4

监管部门

Question 5

GLOSSARY

Answer 5

词汇表；术语汇编

Question 6

ADR=Adverse Drug Reaction

Answer 6

不良的药物反应

Question 7

noxious

Answer 7

有害的；有毒的

Question 8

unintended

Answer 8

非计划中的;意外的

Question 9

causal relationship

Answer 9

因果关系

Question 10

regarding

Answer 10

prep.关于；至于

Question 11

compliance with

Answer 11

遵守；遵照

Compliance with this unified quality 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.

Question 12

consistent with

Answer 12

符合； 与 … 一致

Question 13

prophylaxis

prophylactic

Answer 13

预防

预防的

Question 14

marketed

Answer 14

adj.推向市场的

动词market的过去式和过去分词形式.

Question 15

medicinal

Answer 15

药物的；有药味的；治疗的；

Question 16

AE = Adverse Event

Answer 16

不良事件

Question 17

untoward

Answer 17

adj.麻烦的；不利的；不适当的；失控的

untoward medical occurrence

Question 18

unfavorable

Answer 18

adj.不宜的；不理想的

Question 19

investigational product

Answer 19

试验用药品

Question 20

Applicable Regulatory Requirement

Answer 20

适用的法规要求

Question 21

address

Answer 21

v. 处理, 提出

Question 22

SOPs = Standard Operating Procedures

Answer 22

标准化操作规程

Question 23

audit

Audit Certificat
Audit Report
Audit Trail

Answer 23

审计；查帐

1) A declaration of confirmation by the auditor that an audit has taken place.
2) A written evaluation by the sponsor’s auditor of the results of the audit.
3) 跟踪检查, 审查跟踪 Documentation that allows reconstruction of the course of the events

Question 24

auditor

Answer 24

稽核员, 审计员

Question 25

refer to

Answer 25

涉及；指的是；提及；参考；适用于

Question 26

Blinding / Masking

Answer 26

single-blinding, double-blinding

Question 27

CRF = Case Report Form

Answer 27

病历报告表

Question 28

Clinical Trial / Study

Answer 28

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.

Question 29

Clinical Trial/Study Report

Answer 29

A written description of a trial/study of any therapeutic, prophylacic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report.

Question 30

placebo

Answer 30

[plə'siːboʊ] | 安慰剂

Question 31

comparator (product)

Answer 31

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

Question 32

pharmacovigilance

Answer 32

药物警戒性 _???

Question 33

multicenter trial

Answer 33

多中心临床研究 (：是由多位研究者按同一试验方案在不同地点和单位同时进行的临床试验。各中心同期开始与结束试验。多中心试验由一位主要研究者总负责，并作为临床试验各中心间的协调研究者) http://baike.baidu.com/view/3636918.htm

Question 34

compliance

Answer 34

服从；遵守 Adherence to all the trial-related requirements, Good Clinical Practice requirements, and the applicable regulatory requirements.

Question 35

confidentiality

Answer 35

保密；机密

Question 36

sponsor

Answer 36

赞助者；发起者；主办者

Question 37

Coordinating Commmitte

Answer 37

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

Question 38

Coordinating Investigator

Answer 38

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

Question 39

CRO = Contract Research Organization

Answer 39

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.

Question 40

proprietary

Answer 40

专利的

Question 41

IDMC = Independent Data-Monitoring Committee

Answer 41

An IDMC that may be established by the sponsor to assess at intervals (不时地； 间隔) 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.

Question 42

at intervals

Answer 42

不时地； 间隔

Question 43

impartial

Answer 43

adj.公正的；不偏不倚的 impartial witness

Question 44

informed consent

Answer 44

n.知会同意,知情同意 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 知情同意书.

Question 45

informed consent form

Answer 45

知情同意书

Question 46

IEC = Independent Ethics Committee

Answer 46

An independent body (a review board or a committee, institutional, regional, national, or supranational)

Question 47

pertain to

Answer 47

关于； 属于 The legal status, composition, function, operations and regulatory requirements pertaining to Indenpendent Ethics Committee may differ among countries, but should allow the IEC to act in agreement with *(adj. 按照(与 ... 一致； 与 ... 相符合； 符合； 与-一致)) GCP as described in this guideline.

Question 48

in agreement with

Answer 48

adj. 按照(与 ... 一致； 与 ... 相符合； 符合； 与-一致)