臨床試驗常見英文縮寫

1、臨床試驗常見英文縮寫ADR ( Adverse drug reaction ) 不良反響AE ( Adverse event)不良大事SAE ( Serious Adverse Event )嚴峻不良大事CRF ( Case report form/case record form )病例報告表CRO ( Contract research organization )合同討論組織EC ( Ethics Committee )倫理委員會

2、GCP ( Good clinical practice )藥品臨床試驗管理法律規(guī)范EDC ( Electronic data capture )電子數(shù)據(jù)采集IB ( Investigator's Brochure )討論者手冊ND (Not Done)未做NA (Not Applicable)不適用UK (Unknown)未知PI ( Principal investigator )主要討論者Sub-I(Sub-investi

3、gator)助理討論者QA(Quality assurance)質(zhì)量保證QC(Quality control)質(zhì)量掌握SDV ( Source data verification )原始資料核對SD ( Source data )原始數(shù)據(jù)SD(Source document )原始文件SFDA我國食品藥品監(jiān)督管理局SOP(Standard operating procedure)標準操作規(guī)程IRB機構(gòu)審查委員會ICF(Informed

4、Consent Form)知情同意書TMF ( trial master file )討論管理文件夾臨床試驗常見英文單詞AActive control rAC陽性比照，活性比照 陽性比照，活性比照? Adverse drug reaction ,ADR藥物不良反響 藥物不良反響Adverse event ,AE 不良大事? Approval 批準Assistant investigator 助理討論者? Audit稽查Audit rep

5、ort稽查報告? Auditor稽查員B? Bias偏性，偏倚Blank control 空白比照? Blinding/masking 盲法,設(shè)盲Block 層CCase history 病歷Case report form/case record form ,CRF 病例報告表，病例紀錄表Clinical study 臨床討論Clinical trial 臨床試驗? Clinical trial application ,CTA 臨床

6、試驗申請Clinical trial exemption ,CTX 臨床試驗免責(zé)? Clinical trial protocol ,CTP 臨床試驗方案Clinical trial/study report 臨床試驗報告? COA（藥品檢測報告）Co-investigator 合作討論者? Comparison 比照Compliance 依從性? Computer-assisted trial design ,CATD 計算機幫助試驗

7、設(shè)計Contract research organization ,CRO 合同討論組織? Contract/agreement 合同/合同Coordinating committee 協(xié)調(diào)委員會? Coordinating investigator 協(xié)調(diào)討論者Cross-over study 交叉討論? Cure痊愈CTRB臨床試驗文件夾DDocumentation 紀錄/文件? Dose-reaction relation 劑量一反

8、響關(guān)系Double blinding 雙盲? Double dummy technique雙盲雙模擬技術(shù)E? Electronic data capture ,EDC 電子數(shù)據(jù)采集系統(tǒng)Electronic data processing ,EDP 電子數(shù)據(jù)處理系統(tǒng)? Endpoint criteria/measurement 終點才旨標Essential documentation 必需文件? Excellent 顯效Exclusion

9、 criteria 排解標準FFailure無效，失敗? Protocol amendment 方案補正Q&R? Quality assurance ,QA 質(zhì)量保證Quality assurance unit ,QAU 質(zhì)量保證部門? Quality control ,QC 質(zhì)量掌握Randomization 隨機? Regulatory authorities ,RA 監(jiān)督管理部門Replication 可重復(fù)? Run i

10、n預(yù)備期S? Sample size樣本量，樣本大小Serious adverse event ZSAE 嚴峻不良大事? Serious adverse reaction ,SAR 嚴峻不良反響Seriousness 嚴峻性? Severity嚴峻程度Simple randomization 簡潔隨機? Single blinding 單盲Site audit試驗機構(gòu)稽查? Source data ,SD 原始數(shù)據(jù)Source data

11、 verification ,SDV 原始數(shù)據(jù)核準? Source document ,SD 原始文件Sponsor 申辦者? Sponsor-investigator 申辦討論者Standard operating procedure ,SOP 標準操作規(guī)程? Statistical analysis plan ,SAP 統(tǒng)計分析方案Study audit討論稽查? Subgroup 亞組Sub-investigator 助理討論者?

12、 Subject受試者Subject diary受試者日記? Subject enrollment 受試者入選Subject enrollment log 受試者入選表? Subject identification code ,SIC 受試者識別代碼Subject recruitment 受試者招募? Subject screening log 受試者篩選表System audit系統(tǒng)稽查T&UTrial error試驗誤差?

13、 Trial master file 試驗總檔案Trial objective 試驗?zāi)康? Trial site試驗場所Triple blinding 三盲? Unblinding 破盲Unexpected adverse event ZUAE 預(yù)料外不良大事v&wVariability 變異? Visual analogy scale直觀類比打分法Vulnerable subject 弱勢受試者? Wash-out清洗期Wel

14、l-being福利,健康EDC系統(tǒng)常見英文縮寫1.SCR (screening)篩選? 2.DOV (date of visit)訪視第一天3.ELIG ( ELIGIBILITY )入排合格? 4.DEM ( DEMOGRAPHY )人口統(tǒng)計學(xué)5.MEDSX (medical history)既往史? MHX1 : CANCER RELATED CURRENT MEDICAL CONDITIONS 該腫瘤手術(shù)史及腫瘤相關(guān)病癥? MHX

15、2 : NON-CANCER RELATED MEDICAL CONDITIONS與該腫瘤無關(guān)的病史? 6.VS /VITALS ( VITAL SIGNS )生命體征7.ECOG/PS體能評分note :后面詳細講解? 8. ECG : 12-LEAD ECG 心電圖9. ECHO ( ECHOCARDIOGRAM )超聲心動圖? 10. HAEMA ( LOCAL LABORATORY - HAEMATOLOGY )血常規(guī)11. C

16、HEM ( LOCAL LABORATORY - CLINICAL CHEMISTRY )血生化? 12. URIN ( urine )尿常規(guī)13. C1 (Cyclel )第一周期? 14. WD : End of Therapy/DISCONTINUATION 結(jié)束治療(停止用藥)15. FU ( Follow-up )隨訪? 16.CMED( CONCOMITANT MEDICATIONS )伴隨藥物17. AE ( NON-SE

17、RIOUS ADVERSE EVENTS )不良大事? 18. SAE ( SERIOUS ADVERSE EVENTS )嚴峻不良大事19. EOS( End of Study )結(jié)束討論：腫瘤以病人死亡大事為準? 20. UNS ( Unscheduled Visit)不預(yù)期訪問21.ND (Not Done)未做? 22. NA (Not Applicable)不適用23.UK (Unknown)未知臨床試驗常見語句描述一.臨床試