临床试验专用术语实用小词典

2014-04-22 Tigermed

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适应症(INDICATION)
5 J9 _, c; S7 t7 R试验药物拟定能治疗的疾病或医学问题。
The disease state or medical problem being evaluated with the study agent.

视察(INSPECTION)
- ^% x' O9 K; [$ k; @美国食品药品管理局、申办者、研究基地和/ 或申办方的合作组织实施的官方审查，其目的在于核实研究是否按照法规和指导方针，包括GCP 要求来实施的。
; t  R1 P) H( X% i! D  HAn official audit conducted by regulatory authorities of the Food and Drug Administration, sponsor, or cooperative group at the site of investigation and/or the sponsor. The purpose of the inspection is to verify adherence to applicable regulations and guidelines, including those of Good Clinical Practice.

$ |5 w3 Z" E2 P; ^: |% ?' |机构审查委员会（INSTITUTIONAL REVIEWQBOARD,IRB）
依据美国联邦法规21 第56 款的要求成立的， 由医学专业人员和非医学专业人员组成的独立机构， 其职责是保障任何参加人体试验的受试者的安全和权益。
An independent body of medical and nonmedical members established according to requirements outlined in Title 21, Part 56, of the U.S. Code of Federal Regulations. The IRB, usually institution specific, is responsible for the initial and continuing approval of research involving human subjects, as well as for verifying the protection of safety and rights of those human subjects.

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研究性新药(INVESTIGATIONAL,NEW,DRUG)
按照美国联邦法规21 第312.2 款的规定，研究性新药是指用于临床研究的新药、抗生素或生物制品，也包括用于体外诊断目的的生物制品。
$ R" V4 {: E' {* K4 \- G+ SAccording to Title 21, Part 312.2 of the U.S. Code of Federal Regulations,"means a newOdrug,antibiotic drug,or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes."

) W( q4 I+ Q  w新药研究（IND）申请(INVESTIGATIONAL,NEW,DRUG,(IND),APPLICATION)
+ y1 i. p8 |) l向美国食品药品管理局申请研究新药在人体进行临床试验的过程， 包括药理学、化学、毒理学、临床前研究结果和后续的研究计划等信息。
! G8 r4 ?9 L* j! v" N% \In the United States,process by which investigational new drugs are registered With the Food and Drug Administration for administration to human subjects in clinical trials;includes information on pharmacology,chemistry, toxicology,previous clinical studies results,and future study proposals.

( B7 V, g7 H3 u5 Y+ r% Q4 t研究者（主要研究者）INVESTIGATOR,(Principal,Investigator)
5 p0 O4 r% m7 M. [2 n: N* z作为研究组的领导人物，主要研究者（通常是专业医生或牙科医生）要负责临床试验的实施并确保受试者的安全和福利。要在研究者声明上签字（FDA,1572 表格）。根据美国联邦法规21 第312.2 款的规定，主要研究者是指具体实施临床研究（也就是：在他的直接指示下将试验药物分发给受试者）的个人。如果临床试验由一组人员实施，研究者指这个组的负责人，这个组的其它人员称为次级研究者。
As the leader of the investigational team,this individual (usually a physician or dentist) is responsible for conducting the clinical trial and ensuring the safety and welfare of the study subjects.The investigator signs the Statement of Investigator Form (Form FDA,1572).According to Title 21,Part 3 12.3,of the U.S. Code of Federal Regulations,"means an individual who actually conducts a Clinical investigation (i.e.,under whose immediate direction the drug is administered or dispensed to a subject).In the event an investigation,is conducted by a team of individuals,the investigator is the responsible leader of the team. "Subinvestigator" includes any other member of that team."

                               
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