Factory Audit Report (blank form)

Audit reportAudit responsibility in the y/e and the date the auditor’s report is signedISA 560 subsequent events responsibilities.Should perform audit procedures ,obtain appropriate audit evidence that all events between aperiod.(the date of the fs and the date of audit’s report)(should adj. and disclosure)Audit responsibility in the date the auditor’s report is signed and the date the fs are issued审计报告已经签了审计师就没有责任了除非事情的fact是在签署之日之前auditor就已经知道的，那么要修改。

Discuss with mgt. whether amend the fs and shall carry out the necessary audit procedures,extend the subsequent testing to the date of the new auditor’s report.extend the subsequent events testing to the date of the new auditor’s report and provide a new auditor’s report on the amended fs.Subsequent event1、adjust event 会影响y/e balance是现时义务超过重要性水平就要计提金额，mgt必须调整，否则意见是modifiedIf error is material but pervasive: qualified opinion 要加一句opinion paragraph, qualified ”except for”If error is material and pervasive: adverse opinion2、non-adjust event对不用调整的事项，需要和管理层沟通，记到summary of unadjusted errors 中。

Clinical trial protocol CTP
英文全称 Dose-reaction relation Double dummy Double dummy technique Drop out DSC Effectiveness Electronic data capture EDC Electronic data processing EDP Emergency envelope End point Endpoint Criteria Endpoint criteria/ measurement Equivalence Essential Documentation Ethics committee Excellent Exclusion criteria Factorial design Failure Final point Fixed-dose procedure Forced titration Full analysis set GC－FTIR GC－MS Generic drug Global assessment variable GLU Good clinical practice, GCP Good manufacture practice, GMP Good non-clinical laboratory practice, GLP Group sequential design Health economic evaluation, HEV Hypothesis test Hypothesis testing Improvement Inclusion Criteria
中文全称 主要研究者 产品许可证 上市前许可（申请） 制药业统计学家协会 质量保证 质量控制 监督管理部门 现场评估 严重不良事件 统计分析计划 严重不良反应 原始数据/文件 受试者日记 国家食品药品监督管理局 原始数据核准 受试者入选表 助理研究者 申办研究者 受试者识别代码 标准操作规程 研究人员名单 受试者筛选表 受试和参比试剂 预料外不良事件 世界卫生组织 WHO 国际药品管理当局会议

AUDITOR ’ S REPORTYue Hua Shen / Yan Zi (2014)No.0002ICPA filing number: 020201401000420To all shareholders of ****** Co., Ltd:We have audited the accompanying financial statements of ****** Co.,Ltd (“ Your Company ” ), which comprise the balance sheet as of31 December 2013, the income statement,statement of changes in owner'sequity and cash flow statement for the year then ended, and notes to thefinancial statements.I. Management’ s responsibility for the financial statementsManagement of your Company is responsible for the preparation and fair presentation of financial statements. This responsibility includes: (1)in accordance with the Accounting Standards for Business Enterprises and its relevant provisions, preparing the financial statements andreflecting fair presentation; (2) designing, implementing and maintainingthe necessary internal control in order to free financial statements frommaterial misstatement, whether due to fraud or error.II. Auditors' responsibilityOur responsibility is to express an opinion on these financialstatements based on our audit. We conducted our audit in accordancewith Chinese Certified Public Accountants Auditing Standards.Those standards require that we comply with ethical requirements and plan andperform the audit to obtain reasonable assurance whether the financial statements are free from material misstatement.An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements.The procedures selected depend on the auditors'judgment, including the assessment of the risks of material misstatement of the financial statements,whether due to fraud or error.In making those risk assessments, we consider the internal control relevant to the preparationand fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances,but not for the purpose of expressing an opinion on the effectiveness of the internal control.An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of accounting estimates made by management,as well as evaluating the overall presentation of the financial statements.We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.III.OpinionIn our opinion, the financial statements of your Company have beenprepared in accordance with the Accounting Standards for BusinessEnterprise and its relevant provisions in all material respect, and presentfairly the financial position of your Company as of 31 December 2013,and the results of its operations and cash flows for the year then ended.Guangdong Huaxin Accounting Firm (general partner)Guangdong, ChinaChinese Certified Public Accountant:Chinese Certified Public Accountant:January 3, 2014BALANCE SHEETAS OF 31 DECEMBER 2013Unit: RMB YuanCompany: ****** Co., LtdAsset Ending Beginnin Liabilities and all Ending Beginninbalance g parties ’equity (or balance gBalance shareholders' equity)Balance Current Assets:Current liabilities:Monetary funds Short-termborrowingsTransaction financial Transaction financialasset liabilitiesNotes receivable Notes payableAccount receivable Account payableAccount paid in Account received inadvance advanceInterest receivable Employee’scompensationpayableDividend receivable Tax payableOther account Interest payablereceivableInventories Dividend payableNon-current assets Other accountdue within 1 year payableOther current assets--Non-currentliabilities due within 1yearTotal current assets-Other currentliabilitiesNon-current assets:Total current-liabilitiesAvailable for sale Non-currentfinancial assets liabilities:Maturity investments Long-termborrowingsLong-term account Bonds payablereceivablesLong-term equity Long-term accountinvestment payableInvesting property Special payablesFixed asset Accrued liabilitiesProject in Deferred tax liabilitiesconstructionEngineering material Other non-currentliabilitiesFixed asset disposal Total non-current--liabilitiesProduction biological Total liabilities-assetsOil and gas assets Owner ’s equity( orshareholders’equity)Intangible assets Paid-in capital(orshare capital)Development Capital surplus-expenseGoodwill Less: Treasury StockLong-term expense Earned surplusto be apportionedDeferred tax assets Retained earnings-Other non-current Total owner’s equity-assets(or shareholders’equity)Total non-current-assetsTotal assets-Total liabilities and-owner’ s equity(orshareholders’equity)Prepared by:Audited by:Finance Manager:CompanyLeader:INCOME STATEMENTFOR THE YEAR ENDED 31 DECEMBER 2013Unit: RMBYuanCompany: ****** Co., LtdItems Cumulative Amount inamount in this last yearyearI. Operating incomeMinus: Operating costTaxes and associate chargesSelling and distribution expensesAdministrative expenses-Financial expense-Asset impairment lossPlus: gain from change in fair value( losswith ‘- ‘ )Gain from investment ( loss with‘-‘)Including:income form investment onaffiliated enterprise and joint enterpriseII. Operating profit (loss with‘-‘)-Plus: non-business income--Less: non-business expenseIncluding:loss from non-current assetdisposalIII. Total profit (loss with‘-‘)-Less: Income taxIV. Net profit (loss with‘-‘)-V. Earnings per share(I) basic earnings per share(II) diluted earnings per shareVI. Other comprehensive earningsVII. Total comprehensive earnings-Prepared by:Audited by:Finance Manager:Company Leader:CASH FLOW STATEMENTFOR THE YEAR ENDED 31 DECEMBER 2013Unit: RMBYuanCompany: ****** Co., LtdItems Times Amount in Cumulative this year amount in lastyear1.Cash flows arising from operating 0 activities:Cash received from sales of goods or 1 rending ofservicesRefund of tax and fare received2 Other cash received relating to3 operating activitiesSub-total of cash inflows4 Cash paid for goods and services5 Cash paid to and on behalf of employees6 Tax and fare paid7 Other cash paid relating to operating8 activitiesSub-total of cash outflows9 Net cash flow from operating activities10 2. Cash flows arising from investment0 activitiesCash received from return of11 investmentsCash received from investment income12 Net cash received from disposal of fixed13 assets, intangible assets and otherlong-term assetsNet cash received from disposal of14 subsidiaries and other business unitsOther cash received relating to15investment activitiesSub-total of cash inflows16 Cash paid for acquiring fixed assets,17 intangible assets and other long-term assetsCash paid for acquiring investments18 Net cash received from subsidiaries and19 other business unitsOther cash paid relating to investment20 activitiesSub-total of cash outflows21 Net cash flow from investing activities22 3.Cash flows arising from financing 0 activities:Cash received from absorbing 23 investmentCash received from borrowings24 Other cash relating to financing25 activitiesSub-total of cash inflows26 Cash paid for settling debt27 Cash paid for distribution of dividends28or profit or reimbursing interestOther cash payments relating to 29 financing activitiesSub-total of cash outflows30 Net cash flow from financing activities31 4. Influence on cash due to fluctuation in34 exchange rate increase in cash and cash 35 equivalentsAdd : Balance of cash and cash 36 equivalents at the beginning of the year6. Balance of cash and cash equivalents37 at the end of the yearSupplementary information:0 Attached project of cash flow statement0 1. Net profit is adjusted to cash flow of0 operating activitiesNet profit38 Impairment of assets39 Fixed asset depreciation, depletion of oil40 and gas assets and depreciation of productive biological assetsAmortization of intangible assets41 Amortization of long-term prepaid42 expensesTreatment of losses of fixed assets,43 intangible assets and other long-term assetsLoss on retirement of fixed assets44 Loss of changes in fair value45 Finance costs46 Investment losses47 Decrease in deferred income tax assets48 Increase in deferred income tax liabilities49 Decrease in inventories50 Decrease in operating receivables51 Increase in operating payables52 Others53 Net cash flow from operating activities54 2.Investing and financing activities not 0 relating to cashDebt into capital55 Convertible debt due within one year56 Finance leased fixed assets57 increase in cash and cash 0 equivalentsBalance of cash at the end of this period58Less: balance of cash at the beginning of59this periodAdd: balance of cash equivalents at the60end of this periodLess: balance of cash equivalents at the61beginning of this periodNet increase in cash and cash62equivalentsPrepared by:Audited by:Finance Manager:CompanyLeader:STATEMENT OF CHANGES IN OWNERS’ EQUITYFOR THE YEAR ENDED 31 DECEMBER 2013Company: ****** Co., LtdItems Amount in this year Amount in last yearPaid-Capit Earne Retai Total Paid Cap Earn Ret Totaup al d ned owne-up ital ed aine lcapit surpl surpl earni rs'capi surp surp d ownal us us ngs equit tal lus lus ear ers'实用标准文案I. balance at the end of last yearAdd:change of accounting policy Correction of errorsinprevious periodII.Balance at the beginning of this year III. Increase/ decrease ofy nin equigs ty -------------------------------------amount in this year “(-”means decrease)(I) Net profit(II)Gains and losses directly included in the owners ’ equity change amount in fair value ------------------实用标准文案of financial assets available for sale2.Influence of changes in other owners'equity of investors under the equity method3.Influence of income tax relating to the owners’equity project --------------------4. OthersSubtotal of (I) and (II) (III)Input an reduced capital of owners1. Input capital of owners2.Amount of shares included in the-----------------------------------owners ’ equity3. Others--------实用标准文案(IV) Profit distribution1.Withdrawing earned surplus2.Distribution to all owners (or shareholders)3.Others(V)Internal carrying forward of owners ’equity1.Capital surplus transfers to paid-in capital(or share capital)2.Earned surplus transfers to paid-in capital(or share capital)3.Earned surplus makes up losses ------------------------------------------------------------------------------4. Others--------IV. Balance at the end------of this periodLegal representative:Person in charge of accounting:Leader ofaccounting department:****** CO., LTDNOTES TO THE FINANCIAL STATEMENTSFOR THE YEAR ENDED DECEMBER 31, 2013(All amounts in RMB Yuan)I. Company Profile******* Co., Ltd. (hereinafter referred to as the "Company") is a limitedliability company (Sino-foreign joint venture) jointly invested andestablished by **** Co., Ltd. and ******* Limited on 24 June 2013. OnDecember 26, 2013, the shareholders have been changed to***** CO., LTD and ******* LIMITED.Business License of Enterprise Legal Person License No.:Legal Representative:Registered Capital: RMB(Paid-in Capital: RMB)Address:Business Scope: Financing and leasing business; leasing business; purchase of leased property from home and abroad; residue value treatment and maintenance of leased property;c onsulting andguarantees of lease transaction (articles involved in the industry licensemanagement would be dealt in terms of national relevant stipulations)II. Declaration on following Accounting Standard for BusinessEnterprisesThe financial statements made by the Company are in accordance withthe requirements of Accounting Standard for Business Enterprises, whichreflects the financial position, financial performance and cash flow of theCompany truly and completely.III. Basic of preparation of financial statementsThe Company implements the Accounting Standards for BusinessEnterprises(‘ Finance and Accounting[2006]No.3” ) issued by theMinistry of Finance on February 15, 2006 and the successive regulations.The Company prepares its financial statements on a going concern basis,and recognizes and measures its accounting items in compliance withthe Accounting Standards for Business Enterprises–Basic Standardsand other relevant accounting standards,application guidelines and criteria for interpretation of provisions as well as the significantaccounting policies and accounting estimates on the basis of actual transactions and events.IV. The main accounting policies, accounting estimates and changesFiscal yearThe Company adopts the calendar year as its fiscal year from January 1to December 31.Functional currencyRMB was the functional currency of the Company.Accounting measurement attributeThe Company adopts the accrual basis for accounting treatments and double-entry bookkeeping of borrowing for financial accounting.Thehistorical c ost is generally as the measurement attribute, and whenaccounting elements determined are in line with the requirements of Accounting Standards for Enterprises and can be reliably measured, the replacement cost, net realizable value and fair value can be used for measurement.Accounting method of foreign currency transactionsThe Company’s foreign currency transactions adopt approximate spotexchange rate of the transaction date to convert into RMB in accordancewith systematic and rational method; on the balance sheet date,theforeign currency monetary items use the spot exchange rate of the balance sheet date. All balances of exchange arising from differencesbetween the balance sheet date spot exchange rate and the initialrecognition or the former balance sheet date spot exchange rate, exceptthat the exchange gains and losses arising by borrowing foreign currencyfor the construction or production of assets eligible for capitalization aretransacted in accordance with capitalization principles,are included inprofit or loss in this period;the foreign currency non-monetary items measured at historical cost will still be converted with the spot exchangerate of the transaction date.The standard for recognizing cash equivalentWhen making the cash flow statement, cash on hand and depositsreadily to be paid will be recognized as cash, and short-term (usually nomore than three months), highly liquid and readily convertible to knownamounts of cash with insignificant risk of changes in value arerecognized as cash equivalent.Financial InstrumentsClassification, recognition and measurement of financial assets- The company at the time of initial recognition of financial assets dividesit into the following four categories: financial assets measured at fairvalue with changes included in the profit or loss of this period, loans andreceivables, financial assets available for sale and held-to-maturityinvestments. Financial assets are measured at fair value when initially recognized. Relevant t ransaction costs of financial assets measured atfair value with changes included in the profit or loss of this period arerecognized in profit or loss of this period, and relevant transaction costsof other categories of financial assets are recognized in the amount initially recognized.--Financial assets measured at fair value with changes included in theprofit or loss of this period refer to the short-term sales financial assets, including financial assets held for trading or financial assets measured atfair value with changes included in the profit or loss of this period designated upon initial recognition by the management. Financial assets measured at fair value with changes included in the profit or loss of thisperiod are subsequently measured at fair value, and the interest or cash dividends obtained during the holding period will be recognized as investment income, and the gains or losses of the change in fair value atthe end of this period are recognized in the profit or loss in this period. When it is disposed, the difference between the fair value and the initial recorded amount is recognized as investment income, while adjusting gains from changes in the fair value.--Loans and receivables: the non-derivative financial assets without theprice in an active market and with fixed and determinable recovery costare classified as loans and receivables. Loans and receivables adopt theeffective interest method and take amortized cost for subsequent measurement,and gains or losses arising from derecognition,impairment or amortization are included in the profit or loss of this period.-- Financial assets available for sale: including non-derivative financial assets available for sale recognized initially and other non-derivative financial assets except for loans and receivables, held-to-maturity investments and trading financial assets.Financial assets available for sale are subsequently measured at fair value,and interest or cash dividends obtained during the holding period will be recognized as investment income, and gains or losses arising from the changes in fairvalue at the end of this period are recognized directly in owners' equityuntil the financial asset is derecognized or impaired and then is recognized as the profit or loss in this period.--Held-to-maturity investments: the non-derivative financial assets withclear intention and ability to hold to maturity by the management of the company, a fixed maturity date and fixed or determinable payments areclassified as held-to-maturity investments. Held-to-maturity investmentsadopt the effective interest method and take amortized cost for subsequentmeasurement,and gains or losses arisingfromderecognition, impairment or amortization are included in the profit orloss of this period.Classification, recognition and measurement of financial liabilities- The company at the time of initial recognition of financial liabilitiesdivides it into the following two categories: financial liabilities measuredat fair value with changes included in the profit or loss of this period andother financial liabilities. Financial liabilities are measured at fair value when initially recognized. Relevant transaction costs of financial liabilitiesmeasured at fair value with changes included in the profit or loss of thisperiod are recognized in profit or loss of this period, and relevant transaction costs of other financial liabilities are recognized in the amount initially recognized.-- Financial liabilities measured at fair value with changes included in theprofit or loss of this period include the trading financial liabilities andfinancial liabilities measured at fair value with changes included in theprofit or loss of this period designated upon initial recognition. Financialliabilities are subsequently measured at fair value, and the gains or lossesof the change in fair value are recognized in the profit or loss in this period.--Other financial liabilities: adopting the effective interest method andtaking amortized cost for subsequent measurement. The gains or lossesarising from derecognition or amortization is included in the profit or loss of this period.Requirements for derecognition of financial liabilitiesFinancial liabilities shall be entirely or partially derecognized if the present obligations derived from them are entirely or partiallydischarged.Where the Company enters into an agreement with a creditor so as to substitute the current financial liabilities with new ones,and the contract clauses of which are substantially different from thoseof the current ones, it shall recognize the new financial liabilities in placeof the current ones. Where substantial revisions are made to some or allof the contract clauses of the current financial liabilities,the Company shall recognize the new financial liabilities after revision of the contractclauses in place of the current ones entirely or partially.Upon entire or partial derecognition of financial liabilities,differences between the carrying amounts of the derecognized financial liabilities and the consideration paid (including non-monetary assets surrenderedor new financial liabilities assumed) are charged to profit or loss for thecurrent period.Where the Company redeems part of its financial liabilities,it shall allocate the carrying amounts of the entire financial liabilities betweenthe relative fair values of the parts that continue to be recognized andthe derecognized parts on the redemption date. Differences between thecarrying amounts allocated to the derecognized parts and the consideration paid (including non-monetary assets surrendered and thenew financial liabilities assumed)are charged to profit or loss for the current period.Recognition and measurement for transfer of financial assetsIf the Company has transferred nearly all of the risks and rewards relatingto the ownership of the financial assets to the transferee, they shall bederecognized. If it retains nearly all of the risks and rewards relating tothe ownership of the financial assets, they shall not be derecognized andwill be recognized as a financial liability. If the Company has not transferred nor retained nearly all of the risks and rewards relating to the ownership of the financial assets: (1) to give up the control of thefinancial assets to be derecognized; (2) not giving up control of the financial asset to be recognized based on the extent of its continuing involvement in the transferred financial assets and liabilities arerecognized accordingly.If the transfer of entire financial assets satisfy the criteria for derecognition,differences between the amounts of the following twoitems shall be recognized in profit or loss for the current period: (1) thecarrying amount of the transferred financial asset; (2) the aggregateconsideration received from the transfer plus the cumulative amounts ofthe changes in the fair values originally recognized in the owners’ equity.If the partial transfer of financial assets satisfy the criteria for derecognition,the carrying amounts of the entire financial assets transferred shall be split into the derecognized and recognized parts according to their respective fair values and differences between the amounts of the following two items are charged to profit or loss for thecurrent period: (1) the carrying amounts of the derecognized parts;(2) The aggregate consideration for the derecognized parts plus the portionof the accumulative amounts of the changes in the fair values of the derecognized parts which are originally recognized in the owners’equity.Determination of the fair value of financial instruments-If financial instruments trade in an active market, the quoted price in anactive market determines its fair value; if financial instrument trade not inan active market, the valuation techniques determine the fair value.Valuation techniques include recent market transaction price reference to the familiar situation and volunteer transaction, current fair valuereference to other substantially similar financial instruments, discountedcash flow method and option pricing model and so on.Test and Provisions for impairment loss on financial assets--Except trading financial assets, the Company makes assessment on thecarrying values of financial assets at the balance sheet date. If there isevidence that the fair value of specific financial asset has been impaired,provisions for impairment loss is made accordingly.--Measurement of impairment of financial assets measured atamortized costIf there is objective evidence that the financial asset measured at amortized costhas been impaired, the carrying amount of the financialasset is written down to the present value of estimated future cash flows (excluding future credit losses that have not yet occurred), and the amount of reduction is recognized as impairment loss and is recognizedin the profit or loss of this period. The Company carries out the impairment test of significant single financial asset separately, carries outthe impairment test on insignificant single financial asset from a single or combination of angles, and carries out the impairment test on single asset without objective evidence of impairment along with the financialassets with similar credit risk characteristics to constitute a combination, but does not carry out the impairment test on the provision for impairment of financial assets based on the single in the portfolio. In the subsequent period, if there is objective evidence that the value of financial asset has been restored and recognized relevant to the objective matters occurring after the impairment, previously recognizedimpairment loss shall be reversed and charged into the profit or loss ofthis period. But the book value after the reversal should not exceed theamortized cost at the reversal date of the financial assets supposed no provision for impairment.When the financial assets measured at amortized cost actually occur loss, offset against the related provision forimpairment.-- Available for sale financial assetsIf there is objective evidence that an impairment of available for salefinancial assets occurs,even though the financial asset has not been derecognised, the cumulative loss of decrease of the faire value originally recorded in the owner's equity should be transferred out and charged into the current profit and loss.The cumulative loss is the initial acquisition cost of available for sale financial assets, deducting the fairvalue of the withdrawing principal and amortization amount and impairment loss as well as net impairment amount originally charged into the profit or loss.Recognition and provision for bad debts of accounts receivableIf there is objective evidence that receivables are impaired at the end ofthis period, the carrying value will be written down to its present value of estimated future cash flows, and the amount of reduction is recognizedas impairment loss and is recognized in the current profit or loss. Presentvalue of estimated future cash flows is determined through future cashflows (excluding credit losses that have not been incurred) discounted atthe original effective interest rate,taking into account the value of related collateral(less estimated disposal costs, etc.).Original effective interest rate is the actual interest rate when the receivables are recognized initially.The estimated future cash flows of short-term receivables have small difference from the present value,and the estimated future cash flows are not discounted in determining the related impairment loss.The significant single receivables are separately carried out impairmenttest at the end of this period, and if there is objective evidence that theimpairment has occurred, based on the difference of the present value offuture cash flows less than the book value, the impairment loss is recognized and the provision of bad debts is done. The significant singleamount refers to top five receivable balances or the sum of payments accounting for more than 10% of receivable balances.If there is objective evidence that the individual non-significant receivables impairment has occurred, separate impairment test is done,the impairment loss is recognized and the provision for bad debts is done;other individual non-significant receivables and receivables not impaired after separate test are together divided into several combinations for impairment testing with aging as the similar credit risk characteristics,to determine the impairment loss and do provision for bad debts.In addition to separate provision for impairment of receivables,the company is based on the actual loss rate of receivable portfolio with thesame or similar to the previous year and aging as the similar credit risk characteristics, and combines the current situation to determine the ratioof provision for bad debts as follows:Aging Ratio of provisionWithin one year5%。

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SFDA Glossary： GCP，GLP，TRIAL Accuracy 准确度Active control， AC 阳性对照，活性对照Adverse drug reaction， ADR 药物不良反应Adverse event， AE 不良事件Adverse medical events 不良医学事件Adverse reaction 药物不良反应Alb 白蛋白ALD（Approximate Lethal Dose）近似致死剂量ALP 碱性磷酸酶Alpha spending function 消耗函数ALT 丙氨酸氨基转换酶Analysis sets 统计分析的数据集Approval 批准Assistant investigator 助理研究者AST 天门冬酸氨基转换酶ATR 衰减全反射法AUCss 稳态血药浓度－时间曲线下面积Audit 稽查Audit or inspection 稽查／视察Audit report 稽查报告Auditor 稽查员Bias 偏性，偏倚Bioequivalence 生物等效应Blank control 空白对照Blind codes 编制盲底Blind review 盲态审核Blind review 盲态检查Blinding method 盲法Blinding/ masking 盲法，设盲Block 分段Block 层Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form 病例报告表Case report form/ case record form， CRF 病例报告表,病例记录表Categorical variable 分类变量Cav 平均浓度CD 圆二色谱CL 清除率Clinical equivalence 临床等效应Clinical study 临床研究Clinical study report 临床试验的总结报告Clinical trial 临床试验Clinical trial application， CTA 临床试验申请Clinical trial exemption， CTX 临床试验免责Clinical trial protocol， CTP 临床试验方案Clinical trial/ study report 临床试验报告Cmax 峰浓度Co-investigator 合作研究者Comparison 对照Compliance 依从性Composite variable 复合变量Computer—assisted trial design， CATD 计算机辅助试验设计Confidence interval 可信区间Confidence level 置信水平Consistency test 一致性检验Contract research organization， CRO 合同研究组织Contract/ agreement 协议／合同Control group 对照组Coordinating committee 协调委员会Crea 肌酐CRF（case report form）病例报告表Crossover design 交叉设计Cross-over study 交叉研究Css 稳浓度Cure 痊愈Data management 数据管理Database 建立数据库Descriptive statistical analysis 描述性统计分析DF 波动系统Dichotomies 二分类Diviation 偏差Documentation 记录／文件Dose—reaction relation 剂量－反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double—blinding 双盲Drop out 脱落DSC 差示扫描热量计Effectiveness 疗效Electronic data capture， EDC 电子数据采集系统Electronic data processing, EDP 电子数据处理系统Emergency envelope 应急信件End point 终点Endpoint criteria/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件Ethics committee 伦理委员会Excellent 显效Exclusion criteria 排除标准Factorial design 析因设计Failure 无效，失败Final point 终点Fixed—dose procedure 固定剂量法Forced titration 强制滴定Full analysis set 全分析集GC－FTIR 气相色谱－傅利叶红外联用GC－MS 气相色谱－质谱联用Generic drug 通用名药Global assessment variable 全局评价变量GLU 血糖Good clinical practice， GCP 药物临床试验质量管理规范Good manufacture practice， GMP 药品生产质量管理规范Good non-clinical laboratory practice， GLP 药物非临床研究质量管理规范Group sequential design 成组序贯设计Health economic evaluation, HEV 健康经济学评价Hypothesis test 假设检验Hypothesis testing 假设检验International Conference of Harmonization， ICH 人用药品注册技术要求国际技术协调会，国际协调会议Improvement 好转Inclusion criteria 入选标准Independent ethics committee， IEC 独立伦理委员会Information consent form， ICF 知情同意书Information gathering 信息收集Informed consent, IC 知情同意Initial meeting 启动会议Inspection 视察／检查Institution inspection 机构检查Institution review board, IBR 机构审查委员会Intention to treat 意向治疗（——临床领域）Intention-to –treat， ITT 意向性分析（－统计学）Interactive voice response system， IVRS 互动式语音应答系统Interim analysis 期中分析Investigator 研究者Investigator's brochure， IB 研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward， LOCF 最接近一次观察的结转LC－MS 液相色谱－质谱联用LD50 板数致死剂量Logic check 逻辑检查LOQ （Limit of Quantitation）定量限LOCF， Last observation carry forward 最近一次观察的结转Lost of follow up 失访Marketing approval/ authorization 上市许可证Matched pair 匹配配对Missing value 缺失值Mixed effect model 混合效应模式Monitor 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MS 质谱MS－MS 质谱－质谱联用MTD（Maximum Tolerated Dose）最大耐受剂量Multicenter trial 多中心试验Multi—center trial 多中心试验New chemical entity, NCE 新化学实体New drug application， NDA 新药申请NMR 核磁共振谱Non-clinical study 非临床研究Non-inferiority 非劣效性Non-parametric statistics 非参数统计方法Obedience 依从性ODR 旋光光谱Open-blinding 非盲Open-label 非盲Optional titration 随意滴定Original medical record 原始医疗记录Outcome 结果Outcome assessment 结果指标评价Outcome measurement 结果指标Outlier 离群值Parallel group design 平行组设计Parameter estimation 参数估计Parametric statistics 参数统计方法Patient file 病人档案Patient history 病历Per protocol， PP 符合方案集Placebo 安慰剂Placebo control 安慰剂对照Polytomies 多分类Power 检验效能Precision 精密度Preclinical study 临床前研究Primary endpoint 主要终点Primary variable 主要变量Principal investigator 主要研究者Principle investigator， PI 主要研究者Product license, PL 产品许可证Protocol 试验方案Protocol 试验方案Protocol amendment 方案补正Quality assurance unit， QAU 质量保证部门Quality assurance， QA 质量保证Quality control, QC 质量控制Query list， query form 应用疑问表Randomization 随机化Randomization 随机Range check 范围检查Rating scale 量表Regulatory authorities， RA 监督管理部门Replication 可重复RSD 日内和日间相对标准差Run in 准备期Safety evaluation 安全性评价Safety set 安全性评价的数据集Sample size 样本含量Sample size 样本量，样本大小Scale of ordered categorical ratings 有序分类指标Secondary variable 次要变量Sequence 试验次序Serious adverse event， SAE 严重不良事件Serious adverse reaction, SAR 严重不良反应Seriousness 严重性Severity 严重程度Significant level 检验水准Simple randomization 简单随机Single blinding 单盲Single-blinding 单盲Site audit 试验机构稽查SOP 试验室的标准操作规程Source data verification， SDV 原始数据核准Source data， SD 原始数据Source document, SD 原始文件Specificity 特异性Sponsor 申办者Sponsor—investigator 申办研究者Standard curve 标准曲线Standard operating procedure， SOP 标准操作规程Statistic 统计量Statistical analysis plan 统计分析计划Statistical analysis plan 统计参数计划书Statistical analysis plan， SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者Subject 受试者Subject diary 受试者日记Subject enrollment 受试者入选Subject enrollment log 受试者入选表Subject identification code， SIC 受试者识别代码Subject recruitment 受试者招募Subject screening log 受试者筛选表Superiority 检验Survival analysis 生存分析SXRD 单晶X－射线衍射System audit 系统稽查T1/2 消除半衰期Target variable 目标变量T－BIL 总胆红素T－CHO 总胆固醇TG 热重分析TLC、HPLC 制备色谱Tmax 峰时间TP 总蛋白Transformation 变量变换Treatment group 试验组Trial error 试验误差Trial master file 试验总档案Trial objective 试验目的Trial site 试验场所Triple blinding 三盲Two one—side test 双单侧检验Unblinding 揭盲Unblinding 破盲Unexpected adverse event， UAE 预料外不良事件UV－VIS 紫外－可见吸收光谱Variability 变异Variable 变量Visual analogy scale 直观类比打分法Visual check 人工检查Vulnerable subject 弱势受试者Wash—out 清洗期Washout period 洗脱期Well-being 福利，健康。