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100个金币，救助翻译
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一．病例脱落 1．脱落的判定：所有填写了知情同意书并筛选合格进入试验的患者，均有权随时退出临床试验。无论何时何因退出，只要没有完成临床试验的全程观察，均视为脱落病例。 2．常见脱落原因： l 不良事件 l 违背试验方案（包括依从性差） l 失访 l 患者撤回知情同意书 l 其它 3．脱落病例的处理： 患者脱落后，研究者必须在CRF中填写脱落原因，并尽可能与患者联系，完成所能完成的评估项目，并填写治疗末随访记录表。对因不良反应而脱落，经随访最后判断与试验药物有关者，必须记录在CRF中，并通知申办者。 二．数据管理 1．病例报告表的填写与移交 每个入选病例必须由研究者填写，完成病例报告表。由临床监查员审查后，第一联移交数据管理员，进行数据录入与管理工作。 2．数据的录入与修改 数据录入与管理由第二军医大学统计教研室指定数据管理员负责。数据管理员采用EPI.DATA软件编制数据录入程序，进行数据录入与管理。为保证数据的准确性，应由两个数据管理员独立进行双份录入并校对。 对病例报告表中存在的疑问，数据管理员将产生疑问解答表（DRQ），并通过临床监查员向研究者发出询问，研究者应尽快解答并返回，数据管理员根据研究者的回答进行数据修改、确认与录入，必要时可以再次发出DRQ。 3．数据锁定 在确认数据库正确后，由主要研究者、申办者、统计分析人员对数据进行锁定。锁定后的数据文件不再改动。 4．二次揭盲 经盲态核查确认无误后锁定数据库。行第一次揭盲，分出A、B两组。统计分析完成后第二次开盲，分出试验组和对照组，确定研究结果。 三．临床试验的质量控制 本研究过程中，将由申办者指派的临床监查员定期对研究单位进行现场监查访问，以保证严格遵守研究方案的所有内容和正确填写研究资料。 l 参加研究人员必须经过统一培训，统一记录方式与判断标准。 l 整个临床试验过程均应在严格的盲态下进行。 研究者应按病例报告表填写要求，如实、详细、认真记录在病例记录表（CRF）中各项内容，以确保病例报告表内容真实、可靠。病例报告表不得涂改，如确有笔误，只能在填错的项目上划一横线，在其上填写正确内容，并在旁边签字，注明日期。 l 实验室检查的异常判断标准，以检查单位的正常参考范围为准。 l 临床试验中所有观察结果和发现都应加以核实，以保证数据的可靠性，确保临床试验中各项结论来源于原始数据。在临床试验和数据处理阶段均有相应的数据管理措施。 l 针对可能发生的脱落，积极采取措施，控制病例脱落率在20%以内。 四.试验数据的统计分析 应用SAS9.1.3统计软件进行统计分析。 1．统计分析数据的设定 全分析集（FAS, Full Analysis Set）：指至少使用过一次试验药物，并有治疗后至少一次主要指标测定数据的病例。对于未能观察到全部治疗过程的病例资料，用最后一次观察数据结转到试验最终结果LOCF。排除违反主要入选标准、一次也没用过试验药物、随机化后缺少所有的数据的病例。 符合方案数据分析（Per-Protocol population）: 所有符合试验方案、依从性好、试验期间未服禁止用药、完成CRF规定填写内容的病例，对其疗效进行统计分析。 安全性数据分析（Safety population）: 对所有经随机化分组，并至少服用一次药物，且有安全性资料的全部病例进行分析。 2．统计分析计划 统计分析将采用SAS9.1.3统计分析软件进行计算。计量资料用t检验，计数资料用χ2检验；等级资料用Wilcoxon两样本秩和检验。使用方差分析来评估治疗差异95%的置信区间的情况。 所有的统计检验均采用双侧检验，P值小于或等于0.05将被认为所检验的差别有统计意义。 基础值的均衡性分析：两组入选病例的人口统计学特征进行基线分析，考察两组的均衡性和可比性。并对研究中心、性别、年龄、哮喘病史、基线值FEV1等进行调整分析。 脱落分析：两组总脱落率和由于不良事件而脱落率的比较将采用χ2检验。 有效性分析：不同治疗组的计量资料将采用均数±标准差进行统计描述。与筛选期基础值进行比较，采用配对t检验比较组内前后差异。两组治疗前后的变化采用方差分析（ANOVA）进行比较，对于定量指标，用重复测量方差分析或用协方差分析比较两组的疗效。对于等级指标，两组治疗终点与治疗前用配对秩和检验分析各组处理是否有效。将两组治疗终点与治疗前的等级差做两样本秩和检验比较两组的疗效是否有差异。 安全性分析：用χ2检验比较两组不良事件的发生率，并列表描述本次试验所发生的不良事件；用χ2检验比较实验室检验结果在试验前后正常/异常的的变化情况以及发生异常改变时与试验药物的关系。 |
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2楼2010-01-18 09:32:51
3楼2010-01-18 09:40:43
★ ★ ★ ★ ★ ★ ★ ★ ★ ★
maodx(金币+10,VIP+0):3楼的翻译的不算很专业，但是谢谢你了，赠送你10个金币 1-19 09:19
maodx(金币+10,VIP+0):3楼的翻译的不算很专业，但是谢谢你了，赠送你10个金币 1-19 09:19
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1. Cases falling 1. Shed determine: all filled out the informed consent and screening of qualified patients into the trial, the right to withdraw at any time in clinical trials. Due out anytime, as long as the clinical trials did not complete the whole process observations, are regarded as off cases. 2. Common causes of falling: l adverse events l against the pilot program (including poor compliance) l lost to follow - l patients withdrew informed consent l Other 3. Shedding of cases handled: After falling in patients, researchers must fill out a CRF off reasons, and as far as possible contact with the patient to complete the assessment can not be completed projects, and complete treatment of the end of follow-up logs. Adverse reactions due to fall off, after the final follow-up and testing to determine drug-related persons, shall be recorded in the CRF and notify the sponsor. 二. Data Management 1. Case Report Form Completion and transfer of Each selected clinical cases must be completed by the researcher to complete the case report form. By clinical audit staff review, the first joint transfer of data managers, data entry and management. 2. The data entry and modifications Data Entry and Management of the Second Military Medical University, to specify the data administrator is responsible for statistics teaching and research. Data Administrator using EPI.DATA software development data entry procedures, conduct data entry and management. To ensure the accuracy of the data should be two independent double entry of data managers, and proofread. On the case report form in the presence of doubt, the data administrators will have a Frequently Asked Questions sheet (DRQ), and through clinical inspectors sent to the researchers asked the researchers to answer as soon as possible and return, the data managers in accordance with the researchers to answer data modification, confirmation and entry, if necessary, re-issued by DRQ. 3. Data Lock Confirmation of the database is correct, by the principal investigator, sponsor, statistical analysis of personnel data lock. After the data file is no longer locked changes. 4. Secondary Jie Blind Verified by the blind to lock the database after the confirmation is correct. OK for the first time exposing blind separation of A, B groups. Statistical analysis was completed, the second time to open the blind, separation of the test group and control group to determine the findings. 三. Quality control of clinical trials The course of this study will be bid by inspectors assigned to the clinical research units regularly conduct on-site audit visits to ensure strict compliance with all of the research program content and proper completion of research data. l |
4楼2010-01-18 18:59:49
archerchou
金虫 (小有名气)
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5楼2010-01-19 00:15:43
6楼2010-01-19 09:19:31
7楼2010-01-19 09:33:13
bird870306
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8楼2010-01-19 12:09:46
9楼2010-01-19 13:56:30
sunqizeng
铁杆木虫 (小有名气)
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翻译
★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ...
maodx(金币+190,VIP+0):9楼翻译的很好，谢谢！ 1-19 21:04
maodx(金币+190,VIP+0):9楼翻译的很好，谢谢！ 1-19 21:04
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1. Case dropout 1.1 Dropout determination: All the patients, who filled out informed consent form and were screened into the trial, had the right to withdraw at any time in clinical trials. No matter why or when, any patient who did not complete the whole process of the clinical trials was regarded as dropout case. 1.2 Common causes of dropout a. adverse events b. going against the trial protocol(including bad compliance) c. follow-up lost d. withdrawing informed consent form by the patient e. others 1.3 Handling of dropout Researchers should fill out the reasons for the dropouts in CRF, and do best to contact the patients to complete the evaluation items which could be completed, and fill out treatment-end follow-up record form. Dropouts due to adverse events and finally judged to be related to test drugs must be recorded in CRF and informed to the sponsor. 2. Data management 2.1 Case report form(CRF) filling and transferring CRFs were completed by the researchers, and each patient’s CRF must be completed. The complete CRFs were reviewed by CRA, the first union of which would then be transferred to data administrator, who was in charge of inputting and managing the data 2.2 Data inputting and modifying The data administrator designated by Statistics Teaching and Research Section, The Second Military Medical University was responsible for data inputting and management. Data administrator developed data inputting procedures and conducted data inputting and management using EPIDATA3.0 software. In order to ensure the accuracy of the data, data were inputted and proofread by two administrators independently. If having doubt on the CRFs, the data administrator would have a Directed Reading Question(DRQ), and might send it to the researchers through CRA. Researchers should explain as soon as possible and returned their answer. The data administrator modified, confirmed and inputted data according to the researchers’ answer, re-sending a DRQ if necessary. 2.3 Data locking After it was confirmed correct, the database would be locked by the principal investigator, sponsor and statistical analysis personnel. After locked, the data file was no longer changed. 2.4 Unblinding After it was reviewed blind and confirmed correct, the database was locked. The first unblinding was done to separate to A, B groups. When statistical analysis finished, the second unblinding was done, and the test group and control group were separated to determine the results.. 3. Quality control In the course of this trial, the CRA assigned by sponsor would regularly make an on-site investigation to the hospital to ensure that all the contents of research programs had been strictly abided by, and research materials had been filled out correctly. （1） All the researchers had been trained, moreover, recording methods and criteria for judging were unified. （2） The whole process of clinical trials was conducted under strict blind. （3）The researchers filled the various elements of CRFs according to CRF requirements, truthful, in detail, carefully in order to ensure that the CRFs were true and reliable. CRF should not be altered. If there was any mistake, lined a line over the wrong, filled out the correct on it, signed beside it, and marked date. （4） The abnormal laboratory criterion subjected to the normal reference range of the corresponding unit. （5） Clinical trial results and discovery should be verified to ensure the reliability of data, and ensure that the conclusions were all from the original data. The corresponding data management was practiced in both clinical trials and data processing stages. （6）Against the possibility of case dropout, active measures were taken to control the rate of case dropout within 20%. 4. Statistical analysis of test data Statistical software SAS9.1.3 was used for statistical analysis. 4.1 Choice of statistical analysis data: Full Analysis Set, FAS: those cases who received at least one dose of the assigned treatment and had main indexes tested at least once after treatment. The data of those cases who didn’t completed the whole treatment process was filled out using the last observation data (LOCF Guidelines). Removed the cases that were against the main inclusion criteria ,didn’t take any test drugs at al and missed all data after randomized. Per-Protocol population: All the cases that were in line with trial protocol and of good compliance, not using prohibited drugs during the trial period, and had filled out contents the CRF required. Safety Analysis Set, SAS: all cases randomized to treatment who received at least one dose of the assigned treatment and had safety evaluation data. 4.2 Statistical analysis plan Data were analyzed by SAS 9.1.3 statistical analysis software. T-test, χ2-test, Wilcoxon two-sample rank sum test were applied to measurement data, counting data and grade data respectively. ANOVA was used to evaluate 95% confidence interval of treatment difference. Two-sided test was applied to all the statistical tests. P value less than or equal to 0.05 would be considered as statistical significance. The equitability evaluation of the baseline: baseline analysis for demographic characteristics of the two groups to inspect equitability and comparability, and adjusted analysis of research center, gender, age, asthma history, baseline FEV1. Dropout evaluation: comparison of the total dropout rate and adverse events due to dropout used χ2 test between the two groups. Efficacy evaluation: The different measurement data of the various treatment groups will be used mean ± standard deviation for statistical description. Comparing with baseline in screening period, paired t-test was used to analyze differences within group before and after treatment. Changes in the two groups before and after treatment used analysis of variance (ANOVA) for comparison. For quantitative indicators, Repeated-Measure ANOVA or analysis of covariance (ANCOVA) was used to compare the efficacy of the two groups. For grading indicators, two-sample rank sum test to grade difference between treatment endpoint and pre-treatment were used to compare the difference of the two groups’ treatment efficacy. Security evaluation: χ2 test was adopted for comparing the adverse event incidence of two groups, and a list describing adverse event occurrence in the trial, laboratory test results about normal / unusual changes before and after the test, as well as abnormal changes occurred with relation to test drug. |
10楼2010-01-19 20:35:14
