第一篇:临床研究总结报告
临床研究总结报告
这是临床研究最后一个步骤,用发送呈药物注册上市申请。根据研究实践中取得的信息,经过数据处理、统计分析、归纳和推演写成研究总结报告,内容应该是针对方案中设定的假设和立题,简要总论结果,例如疗效和安全性。如在研究中有新发现,而这新发现并不是该研究要验证的目的、没有在方案中说明,应该建议另立新的研究项目以确定,而不是强调此发现作为总结。总结报告的结构和内容根据各地方规定而不同,可参考下列国际指引:(1)1988年7月FDA指南规定,新药上市申请的临床和统计学部分的结构和内容;
(2)1996年7月ICH指南中提出临床研究报告的结构和内容。原则
临床研究总结报告是申请药物注册上市的重要文件,应该具备下列特性:(1)和研究计划一致,内容逻辑性顺序编排,用笔流畅、没有含糊,适当地方加入图表、坐标等,以帮助容易阅读理解;同时,审阅也是重要步骤,以确定完善这个原则。(2)内容前后一致,没有相互矛盾,尤其是由于多于一个作者编写时更应特别留意。例如,研究者和统计学家,所有参与的作者应互相征询对方意见。(3)符合地方及一切适用法规。
(4)所有有关药物的研究报告应采用统一结构组织。临床研究总结报告大纲 应与方案一致,一般如下。(1)标题页
① 研究方案标题、编号、版本和日期; ② 药物名称/适应证;
③ 申办者信息、负责联络人姓名、电话、传真号码和签章确认;
④ 研究者进展列表,包括研究起止日期,第一个受试者入选日期,最后受试者完成日期,报告和版本日期; ⑤ 主要研究员姓名和签署、研究单位(签章); ⑥ 报告撰写人姓名和签章;
⑦ 遵守《药品临床试验管理规范》指南声明;
⑧ 中国:药品研究机构登记备案代码和原始资料保存地点。(2)摘要
① 通常1~3页的研究总结; ② 必须是独立部分。(3)目录
(4)缩写列表 字汇表,包括包括特别或罕见的名词及其定义。(5)伦理
① 声明获得伦理委员会、政府药监局批准,研究执行是绝对符合医疗道德; ② 全部受试者在加入研究前,已向其详细解释研究详情,并给予充足时间考虑、自愿同意参加,并签署资料册/知情同意书。(6)研究员和研究的管理 ① 管理结构详情; ② 主要和协作研究员列表;
③ 其他组织,例如指导委员会、安全监查委员会、中央实验室、会同研究组织; ④ 报告撰写人,包括负责是应项目研究分析的统计部主管。(7)前言
① 有关研究药物背景(临床前和临床结果); ② 具体的研究适应症;
③ 说明该研究如何配合整体药物开发计划。
(8)研究目的 清楚、明确地列出主要和辅助研究目的,如方案所述。(9)研究计划 ① 整体研究设计和计划的综述概述,帮助读者了解详情(附录方案和方案修正本); ② 期望人群特性和样本含量; ③ 治疗处理
④ 疗效和安全性指标参数;
⑤ 质量保证——各类审核方法和证书;
⑥ 研究方案中的样本含量计算和计划采用的统计学方法,随机表的制定步骤,双盲的落实执行时的改变。(10)研究样本
① 整理样本 点算所有入选受试者,列出征集、随机、中途退出和完成样本例数,分析中途退出和列出这些个案的原因。② 方案误差 列出所有违反方案的逐级试者和偏离状况。(11)疗效评价 ① 全部数据分析
② 人口统计、有关病史信息和其他基准分析,以确定可比性。③ 评价治疗依从性
④ 疗效结果和每一病例数据列表,全部受试者数据分析。⑤ 可评价受试者数据分析,随机分配入各治疗组的实际病例数。⑥ 组间比较
A.口统计学和有关病史特点。B.疗效参数基准分析,以确定可比性。
C.文字、列表、图表、研究参数、显著性测试结果和对应P值。
D.疗效结果:计算组间差异和可信限,并对各组统计值的差异进行显著性检验,列出测试结果和对应P值;以文字、列表、图表表达,分析统计学意义与临床重要性。
E.评价多中心研究的疗效时,应该考虑中心间存在的差异及影响。⑦ 争论
A.是否遵守方案进行;
B.样本如何选取及其理据,按治疗意图分析法或可评价受试者疗效分析; C统计测定意义(P值)和临床意义、结果诠释。(12)安全性评价 ① 用药情况
A.接受药物人数(包括研究药物、对照药物、安慰剂);
B.用药时间,为方便处理分析,可分组归纳(如:〈1天,4天~1星期,2~3月等〉; C.剂量。
② 不良反应 身体结构(体征)或功能(症状)方面的任何非预期转变,包括任何副反应、受伤、毒性或过敏性反应,以及任何同期出现状况,无论认为是否与研究药物有关。A. 总的发生率
* 以治疗处理和生理系统分类; * 将有关原因分组;
* 可以根据不同严重程度归类为轻度、中度、严重。B. 因不良反应/严重不良反应引致退出研究的个别受试者列表 * 死亡
* 严重不良反应; * 因不良反应退出研究;
* 具特殊意义的不良反应而退出研究;
* 严重不良反应叙述:根据研究者提供的资料。C. 具特殊意义的不良反应 D.特殊意义的亚群 ③ 实验室结果
A.如异常实验室结果被认定为为不良反应,与其他不良反应,一起总结; B.计算整个研究期的平均值; C.异常结果的受试者例数及其数值;
D.水平变化:列出在基线和整个过程中的数值转变的例数(低、正常、高)。④ 其他安全性结果(如:生命表征,心电图报告等)(13)讨论
① 简要总论疗效、安全性结果;
② 分析研究执行时的情形,评价有没有对结果造成影响; ③ 有关临床意义的结果;
④ 如有些意外发现,但并不是解答方案中预期问题,不能过分“强调”这些新结果,只能提出建议另作研究确定这些新的或非预期发现; ⑤ 参考适当文献和论点。(14)总论 ① 提出主要结论;
② 检视比较方案叙述的目的和研究结果作出总结。
(15)表格、数据、图表 通常是整页或以上信息,如大小不超过一页,可加插在文中。(16)参考文献 报告中用以支持观点的全部参考文献列表。(17)附件
① 方案和方案修正本; ② 病例报告表样本;
③ 随机取样方法和总随机编码表 ④ 研究者简历; ⑤ 研究者名单(或在报告中); ⑥ 质量评估审核声明; ⑦ 其他。
第二篇:临床研究总结报告结构与内容
兆科药业(合肥)有限公司
文件编号:
版本号:V4.0 SOP-MW-006 Relevant File NO.1 Structure and Content of Clinical Study Summary Report
Structure and Content of Clinical Study Summary Report:
Page 1(the contents of each title in page 1 should be listed in separate page)1.Title Page Title page should includes:Generic name of investigation product, drug registration applicant(with seal), research type, research number, study initiation date, study termination date, principal investigator(with signature), study site(with seal), signature of responsible leader of statistics and seal of statistical company, contact information of application, report date, source information retaining site.2.Table of Contents Present the table of contents and corresponding page number of clinical trial summary report.3.Synopsis of Study Report Briefly introduce the accomplished study, and describe the results with meaningful data rather than written description and P-value.4.Ethics-related Information Declare that this completed clinical trial is conducted in compliance with the ethical principles of medical research of human that have their origin in the Declaration of Helsinki, and that has received independent ethics committee/institutional review board approval, as well as the revision application.The approval document of ethics committee, the clinical trial information which is provided to subjects and the sample of subjects’ informed consent form should be provided.5.Clinical Investigators The clinical trial principal investigator’s name, site, duty in this study and CV(is given in appendix)should be provided, as well as the principal investigators, participants, director of statistical analysis and the writer of clinical study final report.6.Abbreviations The full names of abbreviations in study final report. Main text 1.Introduction
/ 10
兆科药业(合肥)有限公司
文件编号:
版本号:V4.0 Introduce the background, foundation, appropriateness, target population of the investigational product, along with the current therapies and therapeutic efficacy.To document the basic of the conduct of this study, and the cooperation between declarer and clinical study site.2.Trial Objectives The objectives to achieve of this clinical study.3.Trial Management Description of the management structure, management process and the status of conducting in accordance with GCP, should include the information of the training for the participants as well as monitoring/audit, regulations of reporting adverse events, quality control of laboratories, statistics/data management, appropriate action for the problems occur during this study.4.Trial Design
4.1 Description of the Trial Design and Protocol
The description should be concise and clear, if required, relevant graphs can be used to describe directly.A description of the trial design should include: treatment(drug, dose and use), subjects and the sample size, blinding(un-blinded, single-blinded, double-blinded), control types, trial design(parallel and crossover),methods of assigning(random, stratified), duration of the trial and the sequence(the time period between pre-randomization to termination of treatment;the time of treatment interrupting., single-blinding or double-blinding, randomization;to illustrate time arrangement directly by schematic diagram as possible), processing plan and interim analysis for data auditing, problems of safety or special cases.4.2 Consideration of Trial Design and Choosing Control Group d To describe the deterministic accordance and rationality of setting the control group.If control group has not been set, an explanation should be provided;detailed explanations for overcoming selection bias should be provided if without using randomization.To declare the rational consideration of trial-related drug washout period and dose interval.4.3 Selection of Subjects
/ 10
兆科药业(合肥)有限公司
文件编号:
版本号:V4.0 Illustrate the indications, inclusion criteria, exclusion criteria and deletion criteria.4.4 Trial Process Describe the applicable process and related information of the investigational product in detail.The name, specification, dosage form, source(s), batch number(should record each batch number of the investigational product(s)if more than one batch number is used), date of expiration and preservation condition of the investigational product should be provided, as well as the detailed description for the investigational product administration(includes reference(s)for dose determination, route of administration, dosage and administration time).Provide detailed description of the method and procedure of random assignment.To describe the procedure of blinding(label, blind table, emergency document, double-dummy technique), situation of emergent unblinding.Appropriate measures should be taken to prevent distinguishing the investigational product and comparator, and to insure blinding could be administrated during data auditing or interim analysis.A specific statement of control bias should be provided, if blinding is inappropriate or permitted.In addition to the investigational product, information of the other drug should be provided, including administration, prohibition, record and guidelines, as well as the evaluation for the regarding results of any effects on investigational product.Provide the details of actions to secure compliance of the subjects, such as investigational products accountability, subjects’ diaries.4.5 Parameters of Efficacy and Safety Detailed information should be provided about the parameters of efficacy and safety, laboratory examination, examination scheduling, examination methods, responsible staffs, flow chart, notes, definition of parameters and the tests results(including ECG, EEG, imaging tests and laboratory tests).The way of receiving adverse events data, criteria and handling of adverse events, should be provided.The primary criteria of endpoint for evaluating therapeutic effect should be illustrated clearly, the
/ 10
兆科药业(合肥)有限公司
文件编号:
版本号:V4.0 relevant evidence for determination(such as literatures, guidelines)should be provided, also, relevant evidence should be provided if substituted criteria is use,When measuring drug concentration, should specifies the sampling time of biological samples and the interval administration time, and the possible influence of diet, drug combination, cigarette, alcohol, coffee during the time the subjects receiving investigational product and sampling.Sample processing and measurement should be gone through by method validation, and explanation for special cases should be provided.4.6 Quality Assurance for Data Brief description of quality assurance procedure for guaranteeing the data is accurate and reliable should be provided, including the condition of monitoring/auditing, consistency of entered data, range of the values, logical checking, and the procedure of blind reviewing.When necessary, quality-control-related document should be provided, such as the source documents of consistency checking, range of values, rationality checking, blind reviewing, and the record of the communication of investigator(s)and monitor(s).4.7 Proposal of Statistics Handling and Sample Size Determination
Should clearly describe the definition of analysis set(including Fully Analysis Set, Per Protocol Set(PPS), Safety Database Set, which are all determined by Intention To Treat Principle), types of trial(superiority, equivalence or non-inferiority), definition of primary indicator and secondary indicator, statistical analysis method for all kinds of parameters(the method and software should be recognized worldwide), the methods of evaluating therapeutic effects and safety.Should provide description which is focused on the way of analysis, comparison and statistical tests, and the handling of outliers and missing data, including descriptive analysis, parameter estimation, hypothesis testing, analysis of covariate(including the handling of central effect during multicentre trials).Should describe for the hypothesis of testing and treatment effect to be estimated, methods of statistical analysis and relevant statistical model.Treatment effect estimating should be provided with confidence interval along with calculation method.About the hypothesis testing, should specify to use whether one-side test or two-side test, the reasons for using one-side test should be provide.4 / 10
兆科药业(合肥)有限公司
文件编号:
版本号:V4.0 The definition of all kinds of primary and secondary indicators should be described clearly as well as the exclusion of some cases, along with reasons and detailed description.Calculation method of sample size, calculation procedure, the estimated value of statistics during calculating and its source.4.8 Amendment during Study Trial It is inadvisable to amend study protocol, if amendment is required, any amendments(such as changes of treatment groups, inclusion criteria, dosage, sample size), should be explained and has the approval of ethics committee.The amending time, reasons, procedure and whether it has filed should be described in detailed, as well as to demonstrate the effects for the evaluation for the results of the study.4.9
Interim Analysis To illustrate whether it has interim analysis, if has, should conduct in accordance with the definite study protocol and explain the calculation method of alpha spending function.5.Results 5.1 Subjects 5.1.1 Inclusion of Subjects The number of the subjects involved could be described by chart, including the number of screening, randomization, subject completion and subject incompletion(including those withdraw, be removed, interrupt, and drop out).For the reasons of exclusion, incompletion(including visit missing, adverse effect, poor compliance), whether continue to visit after withdrawing, whether to conduct unblinding when withdrawing, should be analyzed and described.Meanwhile, subjects’ demographic information and the other situation of drug combination should be described.5.1.2 Deviations From the Study Protocol Should describe all the deviations from inclusion criteria, exclusion criteria, subject management, subject evaluation and study procedure.Below should be listed in the report, summarized and analyzed:
The subject(s)who is/are involved but not be eligible for inclusion in this study.The subject(s)who is/are eligible for the exclusion criteria but not yet to be excluded.5 / 10 兆科药业(合肥)有限公司
文件编号:
版本号:V4.0
The subject(s)who has/have received incorrect treatment or dosage.The subject(s)who take(s)prohibited medication(s)contemporarily.5.2 Evaluation of Efficacy 5.2.1 Effects Analysis Data Set
Should provide specific definition for the subjects who are involved in effects analysis, including the subjects who have received investigational product, completed the study in accordance with study protocol,or all the subjects who have specific compliance.Should analyze the fully analysis set in general.Should provide detailed description for those subjects who have received investigational product but not yet to be involved to effects analysis data set.5.2.2 Demography and the other Baseline Data To conduct comparable analysis between the trial group by demographic parameter and baseline characteristic data, in general, including the analysis of the fully analysis set which is confirmed by Intention to Treat Principle, and the analysis which is in accordance with protocol set.In multicentre trial, the comparability of each center should be compared.The analysis should includes, age, gender, human race, target disease inclusion criteria, disease progress, severity, clinical specific symptoms, laboratory examination, important prognostic indicator, diseases combined, past history, the other trial-influent factors(such as weight, antibody level)and the other relevant index(such as smoking, alcohol, special diet and menstruation).5.2.3 Compliance To summarize and analyze the measured compliance of each subject(对每个受试者依从性测量的总结及分析。)Should describe the methods/parameters of assurance and recording compliance, such as calculation of medication administration, daily diary card.5.2.4 Analysis of Effects To compare the difference by comparing primary effect index, secondary effect index, pharmacokinetic parameter.Should conduct benefit/risk assessment on each subject when necessary.6 / 10
兆科药业(合肥)有限公司
文件编号:
版本号:V4.0 To perform FAS analysis and PP analysis according to the protocol as stipulated in trial design.Should analyze the classification indicator and numerical index of protocol, provide description of definition basic for newly-setting classification indicator, and if possible, time process which is produced by effect also should be provided.Each branch center of multicentre trial should provide descriptive analysis results(brief summary of branch center), and hypothesis testing may not need to conduct if the sample size is limited.Branch center brief summary should be written by its principal investigator, along with the seal of that branch center and writer’s signature in the title page.The contents should include the relevant information of that center, situation of subject inclusion, deviations from trial protocol, baseline of e.g., demography, descriptive analysis of data, statistical description of primary therapeutic effect index and secondary therapeutic effect index, handling and descriptive statistics of generated adverse effects, comments for the clinical trial of the principal investigator from corresponding branch center.5.2.5 Brief Summary of Efficacy Briefly summarize the efficacy and clinical significance of investigation product by analyzing the primary and secondary therapeutic effect index.5.3 Evaluation of Safety
The subject, who has received investigational products at least once, should be included into safety analytic set.Evaluation of safety has three parts, Part 1: subjects’ level of administering investigational product/exposure, which refers to the dosage, treatment period(s), and number of receiving investigational product;Part 2: to classify the common adverse event and laboratory index in a rational way, compare the difference between each group by using appropriate statistical analysis method, and analyze the possible factors(such as time dependence, dosage, concentration, demographic characteristics)of affecting the frequency of adverse effects/events;Part 3, serious adverse events and the other important adverse event(refer to those adverse events which need clinical procedure, such as stop to receive investigation product, reduce dosage and the other medical treatment)are determined by analyzing the subject(s)who withdraw the trial because of adverse event(s).The causal relationship between all the adverse events and investigational
/ 10
兆科药业(合肥)有限公司
文件编号:
版本号:V4.0 product should be specified.The present adverse event can be summarized by chart, for the adverse events that need to focus on, should provide detailed description.The adverse events of investigational product and control drug should be reported.5.3.1 Level of Administering Investigational Product/Exposure Administering investigational product/exposure time may be described by mean and median, and the number of subjects in some specific period, meanwhile the number of subjects of each sub-group may be listed by the items, such as age, gender, disease, etc.Dose of administering investigational product/exposure may be described by mean and median, also can be expressed as the number of subjects of daily average dose.Administering investigational product/exposure time and dose may be described conjunctively(e.g., the number of subjects in a dose group if the administering investigational product time is at least one month), in the mean time the number of subjects of each sub-group should be listed by the items, such as age, gender, disease.The drug concentration which is related to adverse events or laboratory testing abnormalities should be provided.5.3.2 Analysis of Adverse Event Should analyze all the adverse events of investigational product and control drug, and be illustrated directly by using graphs and charts, which should reveal the frequency, severity of adverse events, also the causal relationship of adverse events and drug administration, adverse events of each system.To compare the frequency of adverse events of treatment group and control group, preferably to compare separately in combination with the severity and causal judgment, if necessary, should analyze the relevance between adverse events and dose of administration, time of administration, feature of baseline and demographic characteristic, respectively.Serious adverse event and the important adverse event that principal investigator consider need to be reported, should be reported and analyzed additionally and attached with case report..The attachment would provide the case report of each subject who has serious adverse event and important adverse event, including case number, demographic characteristic, details of the occurrence of adverse event(initiation time, duration, severity, treatment and the result)and judgment for causal relationship, etc.8 / 10
兆科药业(合肥)有限公司
文件编号:
版本号:V4.0 5.3.3 Safety-related Laboratory Examination According to professional judgment, it would eliminate the non-significant abnormalities that have not relationship with safety, besides, description for significant abnormalities of laboratory examination will be provided.Also, it would supply abnormal items list and the form for the analysis and statistics of treatment group and control group, and the discussion of the changing clinical significance as well as the relationship with investigational product.5.3.4 Brief Summary of Safety Provide overall summary to safety of investigational product, and focus on the adverse event that results in dose adjustment, requiring other treatments, investigational product discontinuation or death.Would present the possible significance of safety for the widely use in clinic of investigational product.5.4 Discussion and Conclusion
Summarize the result of safety and efficacy of clinical study, also, discuss and measure the risk and benefit of investigation product.Briefly and repeatedly report the results are not permitted, as well as raise new result(s).The conclusion should provide evaluation of its significance and possible problems, description for the individual or population obtained benefits during treatment of and problems need to be noticed, and the significance for further study.5.5 Statistical Analysis Report Statistical analyses report, which is provided in appendices, includes, 1.Brief description for the information collection and arrangement of the procedure of the whole clinical trial, which includes objectives, study design, randomization, blinding, blinding review, definition of primary object and secondary objective, regulations of statistical analyses set, handling for missing values and outliers.2.Accurate and complete description of statistical model, which includes, choosing statistical analysis software(should provide the full name and version of the statistical analysis software), the contents of statistical description, regulation for significant level, the choice its reasons for conducting hypothesis testing and establishing confidential interval.If data transformation has been conducted during the process of statistical analyses, rationale of data transformation, and explanation for the assessment of treatment response(base on the transformational data), would be provided.3.Description of the characteristics of baseline for subject inclusion of each group, also the results of statistical tests.4.Statistical description for
/ 10
兆科药业(合肥)有限公司
文件编号:
版本号:V4.0 each observation index(primary index, secondary index and composite index, index of comprehensive evaluation and substituted index)for each group and the results of hypothesis testing.Statistical description results of each observation time;also the test statistics and p-value of hypothesis testing would be provided;for instance, the results of t-test(which can be used to determine if two sets of data are significantly different form each other)should include the case number of each sample, mean value, minimum value, maximum value, t-value and p-value.When conducing analysis of variance for efficiently analyzing the primary index, at least should includes mean value and standard deviation of each site and analysis of covariance form(which would take each treatment, the factor of each site and baseline into analyzing).For the information of crossover design, including the information of treatment sequence and its number of subjects, each baseline at the beginning of each phase, washout period and its duration, the situation of drop-out in each phase and ANOVA table(for analyzing treatment, phase and the interaction of treatment and phase).5.The safety evaluation of each group is mainly described by statistical description, including situation of administrating medication(duration, dosage and medication concentration), adverse event rate, detailed description of adverse event, the changes of laboratory tests results before and after the trial, abnormal changes and its relationship with investigational product.The results above should be indicated by statistical table and chart as much as possible, and the conclusion of statistical analyses should be illustrated by accurate statistics glossary.All the statistical calculation procedure should be save as a file so as to audit.6.References Relevant references should be listed in accordance with Vancouver Style, and the copy of principal references should provide in appendix.10 / 10
第三篇:临床路径总结报告
**医院临床路径实施情况报告(201*年第1季度)
为进一步规范诊疗行为,提高医疗质量,保障医疗安全,控制和降低临床常见病医药费用,减轻患者负担,根据卫生部《临床路径管理试点工作的通知》和《临床路径管理指导原则(试行)》的通知》精神及相关要求,配合公立医院改革试点工作,指导各临床科室开展临床路径管理工作,**医院作了以下工作:
一、临床路径管理试点工作组织实施情况
1、领导重视 我院领导高度重视此项工作,在主管副院长的带领下,先后组织了职能科室及临床科室主任、护士长20余人到**医院、**中心医院参观学习临床路径管理工作,初步学习了临床路径管理工作的成熟经验,为我院开展此项工作奠定了基础。
2、制定临床路径实施方案,确定病种,制定路径表。首先由医务科制订临床路径实施方案;建立各级组织体系及制订各级组织职责;根据遴选病种的要求选择6个专业6个病种作为第1批开展的路径:急性阑尾炎、股骨干骨折、脑出血、社区获得性肺炎、小儿支气管肺炎、子宫肌瘤;多次与临床科室主任及护士长开协调会,制定符合我院实际需要的路径表。
3、组织全院医护人员培训、召开临床路径实施动员大会。2011年**月13日组织开展了“**医院临床路径管理工作启动仪式”,会议由副院长主持,院长及中层干部、临床科室医生及医技人员等80余人参加了此次会议,副院长首先就临床路径的组织体系、实施要求和实施时间安排做了详细介绍,解读了安图县医院临床路径管理工作实施方案,指明了我们实施临床路径的总体目标,并明确相关人员在实施临床路径中的职责。同时由医务科解读了临床路径实施工作中的关键问题,包括临床路径的起源与发展、临床路径的定义、管理组织体系、对临床诊疗工作的作用及意义、临床路径的退出及变异、各科室开展临
床路径的流程及控制。
4、月总结 现此项工作已开展**个月,进入临床路径病例数为***例,因疾病原因或转院退出***例,变异***例,变异主要是医务人员因素导致的,包括未执行路径表单进行检查及复查;未按每天工作实施诊疗工作。
二、*
三、存在的问题
1、科室主任及个案管理员对临床路径的认识不到位,工作中未重视,未严格审核。
2、临床医生未严格执行路径表单开展诊疗工作,主观及随意性较强。
3、临床路径的表单设计是遵循循证医学原则,我院在设定临床路径诊疗项目时,以卫生部发布的路径表为准,诊疗项目基本未变,可单病种限价又不能按路径表单完成,所以导致开展临床路径的病种不能开展单病种限价。
4、职能科室加大监管力度,坚决不允许医务人员因素导致的变异。以上是我院临床路径开展**个月的总结,因为是项新工作,没有经验,我院会在工作中不断总结经验,将此项工作扎扎实实开展,以此为契机,规范诊疗行为,提高医疗质量,保障医疗安全。
**医院
第四篇:临床药师工作总结报告(范文)
光阴如梭,20xx年的工作转瞬又将成为历史,20xx年意味着新的起点、新的机遇、新的挑战。为了更好地完成20xx年工作,扬长避短,现总结如下: 思想上,认真学习贯彻党的十八大精神,充分认识解放思想,开拓创新重要意义,加强理论与实践的联系,提高自己的思想政治觉悟,发扬求真务实精神,做到自觉遵纪守法,自觉抵制行业不正之风,以病人为中心,做好一线窗口及临床药学服务工作,荣获20xx-20xx院优秀团员称号。
在门诊药房工作期间,严格遵守处方调配制度,认真按照四查十对处方审查制度,发现处方中存在的配伍禁忌、剂量、规格等方面的差错,及时与医生沟通。准确调配认真核对并发放处方7万余张,未出现任何差错事故。操作熟练、迅速,尽可能减少病人取药等候时间。对发放到患者手中的药品,主动向患者讲解用药常识与注意事项,尤其对孕产妇及小儿用药注意事项作耐心交代,为群众提供快捷、准确、优良的药学服务。
在临床药学室工作期间,坚持每日参与新生儿科临床查房工作,一方面向医护人员学习临床一些知识,另一方面通过查看病历,监测、审核临床用药,及时了解患者的病情及用药全程。在药物选择、给药剂量、途经、方法等方面向医生及护士提供咨询和药物治疗服务信息。此外,积极配合并圆满完成卫生部医疗质量万里行暨抗菌药物专项整治工作的检查工作。按照医院处方点评制度规定,组织开展门诊处方点评工作。联合计算机中心设计并初步完成处方点评信息化模块,提高处方点评效率。一年来,每月抽查门急诊处方、孕产妇、儿童、抗菌药物处方等进行专项点评。分析评价结果,及时发现、纠正医生不合理用药现象。学习上,加强药学和临床基础理论知识学习,不断充实和更新自己的知识,积极阅读国内外文献,了解并掌握专业的学术新动向,熟练掌握药学基础理论、基本知识和基本操作技能,利用药学专业知识更好地指导临床合理用药。,积极参加本专业的各项学术活动,参加省级年会1次,不定期参加培训班及学习班若干次,发表会议论文1篇。承担1名药学本科生的毕业实习的带教任务,使该生圆满完成实习任务及毕业论文的撰写。
作为一名临床药师,我认为自己做的远远不够,在专业上,我要更加认真努力的学习,提高专业素养,在工作中,应该提高沟通协调能力,和临床医生和护士更好的沟通,提高患者的合理用药情况。美好的xx即将开始,我会不断努力,不断突破,力争将自己的工作进入更高的层次,为我院合理用药的发展,做出贡献。
第五篇:临床医师总结报告2020
总结主要写一下重点的工作内容,取得的成绩,以及不足得出结论,以此改正缺点及吸取经验教训,以便更好地做好今后的工作。下面是小编整理的关于临床医师总结报告范文2020,希望能够帮到大家。
临床医师总结报告范文2020【一】
时光流逝,转眼间我在成长中又渡过一年。回首这走过的一年,很荣幸能与各位同事共同进步,我也在大家的身上学到不少的知识。一年以来我心中的感受便是要做一名合格的儿科主治医师越来越难,要做一名优秀的儿科主治医师则是难上加难。我认为:一名好的儿科主治医师不仅要为人谦和正直,对事业认真兢兢业业。而且在思想政治上、业务能力上更要专研。我,作为一名只学过一年汉语的中年儿科主治医师,需要学习的东西还很多很多。先将这一年的工作总结如下。
本人同往年一样,在院纪院规所容许的框架内,在本人工作职责所规定的范围之中,不顾自身健康状况欠佳的实情,加班加点、尽心尽力、呕心沥血地工作。不论什么时候都能遵守劳动纪律,按时上下班。能坚持一日两次查房。认真带教下级医师和书写电子病历。坚持值夜班、积极诊治和抢救夜班期间来的患儿。积极参加科室内危重患儿的抢救、产科及其它科室的会诊和科内的各类疑难病列讨论。能积极参加院内和科内组织的各类业务和政治学习,并共计支付一个月的工资取得上级规定的专业继续教育学分和公共科目继续教育合格证。能虚心向科主任讨教,在科主任的带领下能把自己份内的工作做的尽善尽美。能独自胜任及从容处理科内所有诊疗工作。
今年曾多次在下夜班期间,根据患儿家长的点名要求及院科两级领导的临时安排,夜间护送其他医生的危重新生儿上乌市上级医院。春节值班期间,在夜间查房时我发现由其他医生管理的一名患儿的症状和临床表现与其所作诊断不符,我当时高度怀疑为“甲流”,于是我立即请科主任会诊,当夜取标本经疾控部门确诊为我地区今年第一列“甲流”患者。
在院科两级领导的关心、关怀和照顾下,我今生有幸第一次上乌市参加“全疆危重新生儿诊疗新进展”,可能是因我工作至今第一次外出参加学术会议的原因,或许是我院儿科硬件及软件建设远远滞后与其它地州级医院的实情对我的触动,参加完回来后,我感慨万分,一回到我院,便按耐不住激动的心情赶紧写了“参会感想与思考”交给了院长。
因本人工作中诊断率、治愈率和服务态度等众多方面表现突出,得到了许许多多患儿家长的肯定和赞许,为此送来了多面感谢的锦旗,也让我上了地方电视新闻。
xxx节上班期间,我ZUI先观察并发现我院第一列新生儿先天膈疝病列,为了明确诊断及时邀请援疆的王琪主任会诊,确诊为先天膈疝后,得到援疆王琪主任的高度好评。近日在援疆王琪主任的指导下,我在儿科首先使用了“新生儿肠外营养”技术,此项技术对不能耐受经肠道喂养或肠道喂养不能达到所需总热量70%的危重新生儿患者有很好的疗效。
感悟
一:“难,坚持真理更难”。在确诊今年我地区第一列“甲流”患者时,受到其它科室及人员的激烈反驳和阻力,若不是疾控部门及时送来的确诊报告,事情将会更加地不靠谱。
二:“艰辛和可怜”。儿科患儿平均住院天数比别的科室短,病床周转率比别的科室大,相及工作量也比其他科室大得多,再加夜间急诊患儿连续不断地就诊和住院,使得每一位下夜班的儿科医师似乎是要跌倒了似的状态回到家里,这是上级再安排我们上乌市上级医院护送危重新生儿,待累死累活将危重患儿护送到乌市后,困倦的身体迫使我们在乌市休息一宿,但因护送费少得可怜,只好男的、女的、医生、护士和驾驶员同开一间房子住下。我们儿科一线值班人员的收入不论是同其它医院同行比、同本院其它科室比、还是和本科室内不值班人员比都少得可怜!
三:“严重滞后”。我院儿科硬软件建设(除电子病历外)不论是同我院其它科室相比,或是同全疆其它同一级别的医院儿科相比均远远落后!这一落后和差距不是在逐年缩小,而是在跨越式拉大!。
四:“极其不正常”。“上门诊坐诊”是每一个医生工作职责中所规定的重要内容,病房干久了、值班值烦了,轮转到门诊工作上一两个月,不仅顺章合理,而且可以给每位医生轮着减压。但是我已有二十年没轮上门诊了,儿科一大半的医生从在本院工作至今从未轮上过儿科门诊。
今年春节除夕我上白班、初一值夜班、初五上白班、初六上夜班、五一长假第一天上白班、第二天上夜班、十一长假第一天上夜班、第五天上白班、第六天上夜班、库尔班节除夕上白班、初一上夜班,平时双休日上午要去病房查房,不知不觉耗到中午回家,整完吃完略做休息,为了应付第二天的病历检查,下午还得上科室内加班写病历。没有休息日,就如长篇小说没有了段落和标点符号,让人浮躁、让人窒息,让人无法阅读和忍受。作为一名儿科执业医师,站在职业道德的高度我们可以无任何条件和无任何怨言地承受这一切压力,但这是一个不可持续的发展和生存模式,积劳成疾累到住院甚至猝死都在所难免。同样是站在职业道德的高度,我们还在一声不吭地承受着来自各方的如“我院是差额单位,不能同其它单位一样涨工资,就这点工资,不干就请走人”,“入院后二十四小时内若不能保质保量地写完电子病历,每份病历罚款五百元”,“我要上院长那里告你”等等训斥、恐吓和无端的谩骂声。面对这一切恶劣的工作环境,我们能做的只有不再让自己的子女再涉足于这个领域。
存在的问题和不足
本人距上次外出进修学习已有十五年的时间了,专业知识有老化的倾向,须再次外出充电和进修学习。在我小的时侯,政府没设双语教育和计算机培训,致使我现在不是很精通电子病历。即:知识老化+暂不精通电子病历是我的也是全部的缺点和不足。
通过这一年的工作,我很幸运从xxx的王x主任那里学到不少本学科的国内前沿知识,业务上也努力做了一些成绩。但这还远远不够,尤其在新生儿科方面上还显得稚嫩。我将在未来继续加倍学习,多思、努力把工作做得更好。
临床医师总结报告范文2020【二】
时光如水、岁月如歌,转眼间又渡过了一年。这一年,很荣幸能与各位同事共同进步,在大家的身上学到很多知识。一年以来我的感受便是要做一名合格的医生不难,但要做一名优秀的医生就不那么简单了。针对这一年我要针对我的工作做一份儿科医生年终工作总结:我认为:一名好的儿科医生要为人谦和正直,对事业认真兢兢业业;在思想政治上、业务能力上更要专研。
一、这一年的工作内容
我今年主要在儿科的住院和门诊工作,由于本所的特点,儿科的工作比较琐碎,除了做好日常的临床工作外,还有儿检、托幼机构幼儿体检、以及联系托幼机构及指导工作等等,有些工作我以前没做过,但为了搞好工作,服从领导安排,我不怕麻烦,向同事学习、向内行请教、自己摸索实践,在很短的时间内便比较胜任儿科的工作,提高了工作能力,在具体的工作中形成了一个清晰的工作思路,能够顺利的开展工作并熟练圆满地完成本职工作。
在医疗业务方面,我一贯树立敬业精神,遵守职业道德履行职责,全面贯彻执行各级领导安排和布置的各项工作和任务,全面履行了一名住院医生的岗位职责。在工作中坚持“精益求精、一丝不苟”的原则,坚持业务、学习不放松。在工作中我尽可能去关心、尊重患者、保护患者隐私。努力钻研业务、更新知识,提高专业技术;严格执行各种工作制度、诊疗常规的操作规程,一丝不苟接待并认真负责地处理每一位病人,在程度上避免了误诊误治,至今未出现任何医疗事故或医疗纠纷;热情接待每一位患者,坚持把工作献给社会,把爱心捧给患者,受到了社会各界的好评;经常阅读杂志、报刊和网络信息,学习了大量新的医疗知识和医疗技术,从而极大地开阔了视野,不断加强业务理论学习,不断汲取新的营养,促进自己业务水平的不断提高;同时,严格要求自己,坚持以工作为重,遵守各项纪律,兢兢业业,树立了自身良好的医德和公众形象。二、思想修养
要想完成工作的责任,首先必须树立正确的世界观和人生观,具备较高的专业素质。在这一年中我认真参加各种学习和活动。是的,作为一名临床医生,我在工作中无意中会考虑不周显得毛毛糙糙,不甚妥当。以更高的要求来要求自己,努力告诫自己:换个角度静心仔细想想如何能做的好一些。有团结协作精神和较强的事业心、责任感。我在工作中自觉遵守医院的各项规章制度,立场坚定,始终和所领导保持高度一致。能做到讲政治、讲学习、讲正气,作风扎实,办事公道正派。
二、素质提升
积极熟悉、掌握国家相关的卫生工作政策和法律法规,积极学习相应的知识,运用于实际工作,能够摆正位置,大事要报告,小事不推诿。
遵守规章制度,强化作风纪律作为一名医务工作者,本人平时注重强化作风纪律观念,严于律己,能够认真落实各项规章制度,以条令条例和规章制度为依据,用正规有序的工作环境来促进个人行为素质养成和捉高,坚持从小事做起、从我做起持之以恒的把强制性的规定、被动式的服从转变为自觉行为,坚决避免和克服工作中拖拉疲沓、浮躁松垮和差错误漏现象,踏踏实实、一步一个脚印的提高自控能力,做到坚持原则,按规章制度办事。
三、展望
通过这一年的工作,我很幸运学到了不少东西,业务上也努力做了一些成绩。但这还远远不够,尤其在临床治疗方面上还显得稚嫩。我将在未来的工作中继续多学,多思、多试努力把工作做的更好。当然,我在工作和学习中还有一些不足之处,须在今后的工作中向各位所长、各科室主任和同事们学习,注重细节,加以改正和提高,告别对于自己的骄傲自满一面,在工作和学习中要坚决改正,争取在以后的工作和学习中取得更优异的成绩。
临床医师总结报告范文2020【三】
本人在院工作近两年,后定在xx外科工作,在科室领导关心及科室同志的帮助下,很好的完成了20xx年的各项工作任务,使自己较快的熟悉新的工作环境,在政治思想、专业技术及生活作风等方面取得较大的进步,主要有以下几个方面:
一、政治思想方面。
本人拥护中国的路线方针政策、坚持四项基本原则,坚持改革开放,努力学习和践行“三个代表”重要思想,在思想、政治及行动上与党中央高度保持一致;敢于批评和自我批评,能积极参加政治学习。始终以一名党员的标准严格要求自己。自觉抵制拜金主义、享乐主义和极端个人主义等不良思想的侵袭,忠于职守,踏实工作,努力提高自己的思想素质和业务道德水平,服务态度端正,热情为伤病员服务。严于律己,廉洁奉公,实事求是,不弄虚作假,作风正派,能自觉遵纪守法,认真执行上级的指示、命令和医院的各项规章制度,服从组织,能认真履行职责和各项制度。待人真诚,尊重领导,积极配合领导及同事的工作。团结协作精神好,与周围同志关系融洽,有较好的群众基础。
二、为部队伤病员方面。
我作为一名军医,为部队伤病员服务,是责任,也是义务。部队医院的存在,关键体现在为部队伤病员的服务水平上,在医疗工作中,始终坚持把对部队伤病员的治疗和管理始终放在第一位。在急诊接诊部队病人,要耐心全面为官兵查体检查,同时进行宣讲军事训练中预防事项,让他们来院好好的看病查体,回部队安安心心进行军事训练。在病房期间,多查房,多交流,了解部队官兵患者的想法,进行有效的治疗及思想上开导。作为部队医院中的军医,坚决树立为部队、为伤病员服务的思想,解决切实他们的困难。
三、专业水平方面。
以前曾在大外科工作,专业性不强,但外科基础较全面,基本功较扎实。在研究生期间,在骨科专业方面有较全面、较系统的了解。但是动手能力与书本知识有一定差距,加强知识在临床工作中的运用与实践,在骨科专业技术水平方面有较大的提高。在工作中不断丰富自己的临床经验,努力提高自己综合分析问题和解决问题能力。在处理伤病员的过程中,能严格按照医疗操作常规进行。严密观察病情,及时准确记录病情,对伤病员的处理得当,从未发生医疗事故及差错。外科是一个协作的团队,离不开科室之间,同事之间配合。作为一名新同志,时刻保持谦虚谨慎,戒骄戒躁,精神饱满,不断学习。
四、生活作风方面。
作为一名干部,在八小时之外,严格要求自已,遵守法纪法规、军队条令条例以及医院各项规章制度。做到令行禁止,不参与黄赌毒场所,保持良好的军人形象。做为一名军人,遵守保密制度,不向外泄密我军情报。一年来的工作,虽然取得了一些的成绩,但离高标准、高质量的要求还有一定差距,特别是在实际操作及论文方面还有待进一步提高,要能胜任本专业工作,任重道远,本人决心更加刻苦学习,努力工作,加强自己的实际操作能力,提高论文质量,争取为科室、医院建设、为部队的医疗卫生事业多做贡献。
临床医师总结报告范文2020【四】
我自X月份参加工作至今已经X年了,在医院、科室领导的关心及同事们的帮助下,较好地完成了各项工作任务,使自己较快地熟悉了新的工作环境,在工作态度、专业技术水平等方面均取得较大的进步,主要有以下几个方面:
一、端正工作态度,热情为患者服务。
作为一名医生,为患者服务,既是责任,也是义务。我们医院对于内陆居民来说还是新生事物,要想在ZUI短的时间内做强做大,我认为首先要提高服务质量,让每一个就诊的患者满意,并以此来扩大我院的知名度。参加工作以后,我努力提高自己的思想素质和业务道德水平,摆正主人翁的心态,急病人所急,想病人所想,竭尽全能地为患者服务;耐心对待每一位患者,不管自己多累,都不厌其烦地做好解释和沟通,争取将两好一满意工作落实到实处。
二、认真负责地做好医疗工作,提高专业技术水平。
1、坚持业务学习不放松。参加工作后我仍然坚持每天学习,每天掌握一种疾病;同时不忘学习本专业研究的新成果,不断汲取新的营养,锻炼科研思维;
2、坚持“精益求精,一丝不苟”的原则,工作过程中严格按照医疗操作常规进行,避免医疗事故及差错的发生;在工作中不断丰富自己的临床经验,时刻保持谦虚谨慎,遇到不懂的问题勇于向上级医师请教,努力提高自己综合分析问题和解决问题能力;严密观察病情,及时准确记录病情,对患者的处理得当;作为一名新医生,戒骄戒躁,精神饱满,不断学习。
三、严格要求自己,积极为医院的发展建言出力。
作为医院的一员,“院兴我荣,院衰我耻”,建言出力谋求医院更大的发展是义不荣辞的责任。在做好本职工作的基础上,积极为科室的发展出谋划策,希望明年的工作量能够再上新高。
总结XX年,在医院领导和同事们的帮助下,我的各项工作完成地较为圆满,但是我不能有丝毫的松懈,因为以后的工作还会面临更大的挑战和机遇。同时与其它先进同事相比还有差距,在今后工作中,我要继续努力,克服不足,创造更加优异的工作成绩。
临床医师总结报告范文2020【五】
本人一年来勤勤恳恳的工作,在各种场合各种环境下,一直不敢忘记自己是个普通的共产党员,一直努力地按照党章的要求去开展业务工作,虽然并没有优秀的表现和突出的贡献,但是,也没有给社会留下污点,没有给医院科室集体丢过脸,也没有给我信仰的党组织丢脸。自己只是一介普通的临床医生,努力做着一个医生应该做的事情,尽着一个医生应该尽的责任与义务,在我的周围,体现着和谐的医患关系。我用这样的和谐感染跟着我的学生们。一直服从配合各级领导的工作。
以下为本的具体工作与收获:
1、病房工作:做为二线医生,指导年轻医生的临床诊疗,负责22张病床。个人共收住院治疗的有400余人次,大部分是安胎或不孕症,小部分是肿瘤或其它病种。主刀各种手术总共260多台,参与30余台。值夜班次数60次。
2、门诊工作:每周3个半天的专家门诊,停诊3次,总共出诊约140次,一年门诊量13421人次(医院统计数字),平均单次门诊量95人次。每次门诊时间平均超过7小时。
3、支持产科建设,本共有267人(登记在案的)在本人的治疗下获得成功的妊娠,其中在本院产科分娩的有23位,均平安顺利。
4、写了6篇科普文章,宣扬中医药的优势。没有专业论文,主要是因为本人的观点并不能获得行内的认可,即使写了也是白费口舌。但是个人的经验教训并非深埋心底,而是毫无保留的献给学生们。没有申报课题,因为没有时间、科研水平是缺陷,同时也反感当今的科研现状。
5、通过网络等途径利用业余时间义务回答病人的问题总共3500多个。
6、强烈反感给医生送和强烈反对医生接受,及时杀灭病人或家属们送苗头与动机共80人次,数额不详。因为没有收,所以上交数为零。
7、获得病人的各种表扬(锦旗、表扬信之类)70多人次,带动病房同事的工作积极性,多人多次获得病人的好评。
8、以下为本接受病人的礼品清单:各种饮料30多瓶(基本上出门诊时喝了)、蛋糕点心饼干之类若干包、大米10斤、番薯20斤、青菜10斤、水果篮若干、零星水果若干、活鸡4只、红鸡蛋150个左右、姜醋猪脚约10碗、萝卜干3斤、菜干10扎等等,还有一些零星的零食。
以上为本人对过去一年的总结,希望自己发扬优点,改正缺点,在新的一年里保持健康的身体,更好的为人民服务,更好的为医院工作。