Evaluation of an ITS for the Passive Voice of the English Language Using the CIAO! Framewor
专业英语翻译教案
浙江师范大学外国语学院课程大纲及教案专业名称：英语专业课程名称：《翻译》（1）主导教材：毛荣贵《新世纪大学英汉翻译教程》所属课程组：翻译组课程负责人：适用年级：英语专业本科2003级200 5 —200 6 学年第一学期翻译（1）（2）课程大纲一、课程概况课程名称：翻译课程类别：专业基础课课程编号：030903081，030903082学分：4 学时：68 开课学期：五、六二、课程教学目标和要求1、[教学目标]通过本课程的教学，帮助学生有效提高翻译实践能力和理论认识，达到高等学校英语专业英语教学大纲对其翻译能力的基本要求，即：能运用翻译理论与技巧，将英美报刊上的文章以及文学原著译成汉语，或将我国报刊、杂志上的文章和一般文学作品译成英语，译文忠实、流畅，译速每小时250-300个英文单词汉字，使之可以胜任未来的中学英语教学以及其他涉及翻译能力的工作。
2、[课程要求]本课程为系列专业基础课，由英译汉和汉译英组成，要求学生按顺序修读。
为达到课程教学的目的，采用讲练结合的方式，布置相当数量的课后作业要求学生按时按量完成，并积极参与课堂讨论。
三、教学内容与教学安排1、[教学内容要点]本课程教学以实践为主，理论为辅，重点是翻译技巧的介绍与练笔，翻译内容涉及各类文体、各个领域。
课程安排按照讲练结合的原则展开，帮助学生有步骤有针对性地训练翻译的基本技能。
通过大量的练习和讲评，强化学生对不同文本语体特点和翻译原则的认识，为其将来从事翻译工作或运用英语作为工作语言打下坚实的双语转换实践基础。
2、[教学安排]本课程教学依据教学大纲，安排在本科三年级上、下两学期进行，共计68学时，其中36学时为英译汉，32学时为汉译英，每周2学时。
教学计划允许授课教师在具体操作中有一定的灵活度，但至少应包含以下3部分的主题内容：1)翻译概述（含翻译的标准、原则、过程、中外翻译简史及翻译名家的主要观点等）；2)翻译技巧讲练（介绍主要的英汉互译技巧，结合学生的练笔进行讲评）；3)多视角的翻译实践与研究（不同领域的翻译实践及其操作原则与技巧，如外来词翻译、报刊标题及新闻翻译、旅游翻译、科技翻译、广告翻译、文化与翻译等；在实践的基础上开始涉猎翻译的前沿理论，提高学生对翻译的理性认识，目的在于训练其解决问题的探索能力，为其将来从事翻译实践或理论研究开辟一个窗口）。
高二英语英语学习同伴评价练习题30题
高二英语英语学习同伴评价练习题30题1.Your classmate's speech was clear and easy to understand. What's your evaluation of his/her oral expression?A.ExcellentB.GoodC.AverageD.Poor答案：B。
选项A“Excellent”表示非常出色，仅清晰易理解还达不到这个程度。
选项B“Good”比较符合清晰易理解的表现。
选项C“Average”一般是中等水平，此处不太符合。
选项D“Poor”表示差，与题干描述不符。
2.During the class discussion, your partner spoke fluently without many pauses. How would you rate his/her oral expression?A.Very goodB.GoodC.FairD.Poor答案：A。
选项A“Very good”很适合流利无很多停顿的情况。
选项B“Good”稍显不足。
选项C“Fair”一般，不符合流利的描述。
选项D“Poor”差，不符合。
3.Your classmate's presentation had some mistakes in pronunciation. What's your assessment of his/her oral expression?A.Above averageB.AverageC.Below averageD.Poor答案：C。
选项A“Above average”高于平均水平，有发音错误不应是这个评价。
选项B“Average”中等水平也不太准确。
选项C“Below average”低于平均水平，有发音错误符合这个评价。
选项D“Poor”差，有点过于严重。
4.Your partner's speech was engaging and held the audience's attention. What's your evaluation of his/her oral expression?A.ExcellentB.Very goodC.GoodD.Fair答案：B。
高考英语续写满分作文范文欣赏新高考
高考英语续写满分作文范文欣赏新高考全文共3篇示例，供读者参考篇1Appreciating the New Gaokao English ExamAs a student facing the paramount challenge of the Gaokao, the national college entrance examination, I cannot help but express my profound admiration for the recent reforms to the English section. These innovative changes have breathed new life into an examination that was once perceived as a mere regurgitation of rote knowledge, transforming it into a true test of comprehensive language proficiency.One of the most significant enhancements lies in the integration of reading comprehension passages that encompass a diverse array of topics and genres. No longer are we confined to the realm of sterile, academic texts devoid of real-world relevance. Instead, we are presented with a kaleidoscope of engaging materials, ranging from thought-provoking essays on contemporary issues to excerpts from literary masterpieces that ignite our imaginative faculties.This breadth of exposure not only enriches our linguistic repertoire but also fosters a deeper appreciation for the nuances of language and the intricate tapestry of human experience woven into the written word. It is a testament to the examination's recognition that true mastery of a language extends far beyond mere grammatical rules and vocabulary lists.Moreover, the inclusion of authentic listening comprehension materials, replete with the cadences and idiosyncrasies of natural speech, has been a revelatory experience. Gone are the days of contrived, artificially enunciated dialogues that bore little resemblance to the dynamic ebb and flow of real-world conversations. We are now challenged to attune our ears to the rich tapestry of accents, inflections, and colloquialisms that pervade the English language, thereby better equipping us for the realities of cross-cultural communication.Yet, perhaps the most transformative aspect of the new English examination lies in its emphasis on productive skills – the art of expressing oneself coherently and persuasively through the written and spoken word. The incorporation of essay writing tasks and oral presentations demands a level of linguistic dexterity that transcends mere comprehension, challenging us to synthesize our knowledge, articulate our thoughts with clarityand precision, and convey our ideas in a manner that resonates with our audience.This focus on productive skills is a resounding acknowledgment of the fact that true language proficiency is not a passive endeavor but an active, dynamic process that requires us to engage with the language on a deeper, more substantive level. It is a recognition that the ultimate goal of language acquisition is not merely to understand but to communicate, to exchange ideas, to persuade, and to leave an indelible mark on the world through the power of words.Furthermore, the inclusion of translation tasks, both from English to Chinese and vice versa, has shed light on the intricate art of bridging linguistic and cultural divides. In an increasingly globalized world, where the free exchange of ideas transcends borders and boundaries, the ability to navigate the nuances of cross-linguistic communication has become an invaluable skill. Through these translation exercises, we are challenged to go beyond mere word-for-word renditions, delving into the depths of cultural contexts, idiomatic expressions, and subtle shades of meaning that can so easily be lost in literal translations.Ultimately, the new Gaokao English examination stands as a testament to the evolving paradigm of language education inChina. It is a bold embrace of the multifaceted nature of linguistic proficiency, recognizing that true mastery of a language is not merely a matter of memorization but a holistic journey that encompasses comprehension, expression, cultural awareness, and the ability to navigate the complexities of cross-cultural communication.As I approach this formidable challenge, I cannot help but feel a profound sense of excitement and gratitude. The examination's newfound emphasis on authentic, real-world language usage, its acknowledgment of the importance of productive skills, and its recognition of the inextricable link between language and culture have imbued the pursuit of English proficiency with a renewed sense of purpose and relevance.No longer is it a mere academic exercise, but a gateway to a world of boundless possibilities – a world where ideas transcend borders, where cultures converge, and where the power of language serves as a catalyst for personal growth, intellectual curiosity, and cross-cultural understanding.As I embark on this journey, I am keenly aware of the challenges that lie ahead, but I am also emboldened by the knowledge that this examination is not merely a hurdle toovercome but a transformative experience that will shape me into a more well-rounded, globally aware, and linguistically adept individual.With each comprehension passage I analyze, each essay I compose, and each oral presentation I deliver, I am honing not only my linguistic skills but also my ability to think critically, to express myself with clarity and conviction, and to engage with the world around me in a meaningful and impactful way.And while the road ahead may be arduous, I take solace in the knowledge that the new Gaokao English examination is a true reflection of the evolving landscape of language education –a landscape that celebrates diversity, fosters cultural understanding, and equips us with the tools to navigate the complexities of a globalized world with confidence and poise.In the end, the true value of this examination lies not in the scores we achieve or the accolades we garner, but in the transformative journey it represents – a journey that will shape us into well-rounded, globally aware, and linguistically adept individuals, poised to make our mark on the world through the power of language.篇2A New Era of English Testing: Appreciating the Gaokao Composition ChangesAs a high school senior gearing up for the infamous gaokao, China's national college entrance examination, I can't help but feel a mix of trepidation and excitement. For years, the English composition section has been a dreaded part of the test, with students struggling to craft cohesive and compelling essays within a strict time limit. However, the recent changes introduced to this section have brought a breath of fresh air, promising a more engaging and thought-provoking experience fortest-takers like myself.One of the most significant changes is the shift from the traditional essay format to a "composition continuation" task. Instead of having to write an entire essay from scratch, we are now presented with the beginning of a story or narrative, and tasked with continuing and concluding it in a creative and logical manner. This new approach not only tests our writing abilities but also challenges our critical thinking and storytelling skills.As someone who has always been fascinated by the art of storytelling, I find this change incredibly exciting. Rather than regurgitating formulaic essays on overused topics, we now have the opportunity to let our imaginations run wild, crafting uniqueand captivating narratives that reflect our individuality and perspective.Moreover, the composition continuation task allows us to showcase our ability to understand and interpret context, a crucial skill in the ever-evolving global landscape. By providing us with a specific scenario or premise, the test evaluates our ability to grasp the nuances of the given situation and seamlessly weave our continuation into the existing narrative.Another aspect of the new composition section that I find particularly intriguing is the emphasis on cultural awareness and cross-cultural understanding. Many of the prompts and scenarios presented in the samples I've seen touch upon themes of cultural exchange, global perspectives, and the complexities of navigating diverse environments. As someone who aspires to pursue a career in international relations or diplomacy, this focus on cultural competence resonates deeply with me.Studying the full-score sample compositions has been an enlightening experience, offering insights into the thought processes and creative approaches of top-scoring students. I've been in awe of the rich imagery, captivating storylines, and nuanced cultural references woven into these exemplary works. Each sample serves as a source of inspiration, challenging me topush the boundaries of my own writing abilities and embrace a more global mindset.One composition that particularly stood out to me was a continuation of a narrative about a young Chinese student studying abroad in the United States. The writer seamlessly integrated elements of cultural shock, personal growth, and the challenges of adapting to a new environment, all while maintaining a cohesive and engaging storyline. The depth of cultural understanding and empathy displayed in this piece was truly remarkable, and it left me with a newfound appreciation for the richness of cross-cultural experiences.As I prepare for the gaokao, I find myself eagerly anticipating the English composition section, viewing it not as a daunting obstacle but as an opportunity to showcase my creativity, critical thinking, and global awareness. The changes introduced to this section have breathed new life into the test, transforming it from a mere evaluation of writing proficiency into a platform for students to express their unique voices and perspectives.In the rapidly globalizing world we live in, the ability to communicate effectively across cultures and navigate diverse contexts is invaluable. By embracing the composition continuation task and the emphasis on cultural competence, thegaokao is equipping us, the next generation of leaders and global citizens, with the skills necessary to thrive in an increasingly interconnected world.As I pore over the full-score samples, studying the intricate storytelling techniques and cultural nuances, I can't help but feel a sense of excitement and determination. This new era of English testing challenges us to think beyond the confines of traditional essay writing, encouraging us to embrace our individuality, cultivate our cross-cultural understanding, and express ourselves through the powerful medium of storytelling.In the end, the composition continuation section of the gaokao is not merely a test of writing ability; it is a gateway to unlocking our potential as global communicators, storytellers, and cultural ambassadors. And as I stand on the precipice of this new chapter in my academic journey, I eagerly embrace the challenge, ready to let my words and imagination take flight, leaving an indelible mark on the pages of the gaokao and beyond.篇3Appreciating the New Gaokao English Continuation CompositionsAs a high school student gearing up for the infamous gaokao, the national college entrance examination in China, I can't help but feel a mix of trepidation and excitement. The English portion, in particular, has long been a source of anxiety for many of us, with the dreaded writing section often proving to be the biggest stumbling block. However, with the recent introduction of the continuation composition format, I find myself unexpectedly captivated by the creative possibilities it presents.For those unfamiliar with the new format, the continuation composition prompts students to read a given passage and then continue the story or develop the ideas presented. This departure from the traditional essay writing tasks has been met with both curiosity and skepticism from students and educators alike. Some have criticized it as being too open-ended and subjective, while others have embraced it as a refreshing change that encourages critical thinking and creativity.As someone who has always enjoyed creative writing, I must admit that I was initially apprehensive about the new format. The thought of having to seamlessly integrate my writing with an existing passage seemed daunting, and I feared that my unique voice might be lost in the process. However, after carefullystudying some of the exemplary continuation compositions released by the examination board, I found myself in awe of the ingenuity and artistry on display.One composition that particularly resonated with me was the continuation of a passage about a young girl's encounter with a stray dog. The original passage painted a vivid picture of the girl's initial hesitation and eventual connection with the animal. The continuation composition, however, took the story in an entirely unexpected direction, exploring themes of compassion, responsibility, and the human-animal bond in a way that was both thought-provoking and emotionally resonant.What struck me most about this composition was the writer's ability to seamlessly blend their own voice and perspective with the existing narrative. The transition from the original passage to the continuation was so smooth that it felt like a single cohesive story, and yet the writer's unique style and creativity shone through in every sentence. It was a masterful balancing act that demonstrated not only exceptional writing skills but also a deep understanding of the source material and the prompt's underlying themes.Another composition that left a lasting impression on me was the continuation of a passage discussing the impact oftechnology on modern society. The original passage presented a balanced view, highlighting both the potential benefits and drawbacks of our increasingly digitized world. The continuation, however, took a bold stance, passionately arguing for a more mindful and responsible approach to technological advancement.What I found most impressive about this composition was the writer's ability to craft a persuasive and well-reasoned argument while still maintaining a creative and engaging narrative. The use of vivid imagery and relatable analogies not only strengthened the writer's position but also made the composition a captivating read. It was a masterful blend of intellectual rigor and artistic expression, showcasing the writer's versatility and command of the English language.As I delve deeper into the world of continuation compositions, I find myself increasingly inspired by the creativity and ingenuity on display. Each exemplary work serves as a testament to the boundless potential of the English language and the power of the written word to captivate, enlighten, and provoke thought.Moreover, I can't help but appreciate the way these compositions challenge traditional notions of what constitutes"good writing." In the past, we were often taught to adhere to rigid structures and formulaic approaches, but these exemplary works demonstrate the value of breaking free from those constraints and embracing a more organic and expressive style.Of course, mastering the art of the continuation composition is no easy feat. It requires a delicate balance of critical reading skills, creative writing abilities, and a deep understanding of language, structure, and narrative. But for those of us who are willing to embrace the challenge, the rewards are immense.As I prepare for the gaokao and beyond, I find myself increasingly drawn to the world of creative writing and the endless possibilities it presents. The continuation composition format has opened my eyes to the boundless potential of language and has inspired me to push the boundaries of what I thought was possible in my own writing.While the gaokao may still be a source of stress and anxiety for many students, I can't help but feel a sense of excitement and gratitude for the opportunity to explore this new and innovative format. It has challenged me to think outside the box, to embrace my creativity, and to approach writing not just as a means of communication, but as an art form in its own right.As I embark on this journey of self-expression and discovery, I can only hope that my words will resonate with others the way the exemplary continuation compositions have resonated with me. And who knows? Perhaps one day, my own continuation composition will inspire and captivate future generations of students, just as I have been inspired and captivated by those that came before me.。
韩国高考英语试卷
Part I Listening Comprehension (25 points)Section A (5 points)Directions: In this section, you will hear five short conversations. At the end of each conversation, a question will be asked about what was said. Both the conversation and the question will be spoken only once. After each question there will be a pause. During the pause, you must read the four choices marked A), B), C), and D), and decide which is the best answer. Then mark the corresponding letter on Answer Sheet 2 with a single line through the centre.1. A) The man is looking for a bookshop.B) The woman is going to buy a book.C) The man is going to be a teacher.D) The woman is going to help the man.2. A) The man will take the woman to the cinema.B) The woman will watch the movie alone.C) The man doesn't want to go to the cinema.D) The woman doesn't like the movie.3. A) They will go to the park.B) They will go to the library.C) They will go to the museum.D) They will go to the beach.4. A) The man will make a cake.B) The woman will help the man.C) The woman will buy a cake.D) The man will go to the store.5. A) The man is tired of his job.B) The woman thinks the man should change his job.C) The man is happy with his job.D) The woman is worried about the man's job.Section B (20 points)Directions: In this section, you will hear a passage three times. When the passage is read for the first time, you should listen carefully for its general idea. When the passage is read for the second time, you are required to fill in the blanks with the exact words you have just heard. For the third time, you should check what you have written.The world is becoming increasingly interconnected, and the internet plays a crucial role in this process. (1) ______, the internet has revolutionized the way we communicate, access information, and conduct business. (2) ______, people can now connect with each other from any part of the world, making long-distance relationships and collaborations easier than ever before. Moreover, the internet has become an indispensable tool for education, allowing students to access a wealth of resources and interact with experts and peers from all over the globe.However, along with its benefits, the internet also brings challenges. (3) ______, the internet has made it easier for individuals to spread misinformation and fake news, which can have serious consequences for society. Additionally, excessive use of the internet can lead to addiction and mental health issues.To harness the full potential of the internet while mitigating its negative effects, it is essential to promote digital literacy and responsible use. (4) ______, governments, educational institutions, and parents should work together to ensure that individuals are equipped with the necessary skills to navigate the digital world safely and effectively.Part II Reading Comprehension (30 points)Section A (15 points)Directions: There are three passages in this section. Each passage is followed by some questions or unfinished statements. For each of them there are four choices marked A), B), C), and D). You should decide on the best choice and mark the corresponding letter on Answer Sheet 2 with a single line through the centre.Passage 1The rapid development of technology has greatly changed our lives. One of the most significant advancements is the rise of smartphones. Smartphones have become an integral part of our daily lives, allowing us to stay connected, access information, and perform various tasks with ease. However, this convenience comes at a cost, as excessive use of smartphones can lead to negative consequences.Question 1: What is the main idea of the passage?A) The benefits of smartphones.B) The drawbacks of smartphones.C) The role of smartphones in modern life.D) The impact of smartphones on society.Passage 2Exercising regularly is crucial for maintaining good health. Physical activity not only helps us stay fit but also improves mental well-being. However, many people struggle to find time to exercise, and some even believe that they are too busy to engage in physical activities. In this passage, we will explore the importance of exercise and provide tips on how to incorporate it into a busy lifestyle.Question 2: What is the purpose of the passage?A) To encourage people to exercise regularly.B) To provide a list of exercise benefits.C) To discuss the challenges of exercising.D) To compare different exercise routines.Passage 3The environment is facing numerous challenges, including climate change, pollution, and the loss of biodiversity. It is essential for individuals and governments to take action to protect the planet. This passage will discuss the importance of environmental protection and highlight some practical steps that can be taken to contribute to a sustainable future.Question 3: What is the main argument of the passage?A) The importance of environmental protection.B) The causes of environmental degradation.C) The impact of human activities on the environment.D) The role of governments in environmental protection.Section B (15 points)Directions: Read the following passage and choose the best word to complete each sentence. Mark the corresponding letter on Answer Sheet 2 with a single line through the centre.Despite the many challenges faced by the world today, (5) ______, there is still hope for a better future. (6) ______, technology has the potential to solve many of the problems we are facing, from climate change to poverty. (7) ______, it is crucial for us to use technology responsibly and ensure that it benefits everyone.Part III Writing (25 points)Directions: Write an essay of about 150-200 words on the following topic:Do you agree or disagree with the following statement? Social media has a negative impact on the mental health of young people. Use specific reasons and examples to support your answer.Remember to write clearly and coherently. You may begin your essay with a statement of your opinion, and then support your opinion with relevant reasons and examples.。
评价评估的英语作文句子
1.Evaluating and assessing are essential processes in making informed decisions.评估和评价是做出明智决策的基本过程。
2.The ability to accurately evaluate a situation can significantly impact the outcome of any project.准确评估情况的能力可以显著影响任何项目的结果。
3.In order to make a fair assessment,one must consider all relevant factors and perspectives.为了做出公正的评价，必须考虑所有相关因素和视角。
4.Regular evaluations can help identify areas for improvement and enhance overall performance.定期评估可以帮助识别改进领域并提高整体表现。
5.An unbiased evaluation is crucial for maintaining the integrity of the assessment process.无偏见的评价对于保持评估过程的完整性至关重要。
6.The process of evaluation involves a systematic analysis of data to draw meaningful conclusions.评价过程涉及对数据的系统分析，以得出有意义的结论。
7.Effective assessment strategies can lead to better decisionmaking and more efficient resource allocation.有效的评估策略可以带来更好的决策制定和更高效的资源分配。
美国DMF目录及要求
Drug SubstanceChemistry, Manufacturing, and Controls InformationDRAFT GUIDANCEThis guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 180 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.For questions regarding this draft document contact (CDER) Stephen Miller (301) 827-2392, (CBER) Chris Joneckis (301) 435-5681, or (CVM) Dennis Bensley (301) 827-6956.U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Review (CBER)Center for Veterinary Medicine (CVM)January 2004CMCDrug Substance Chemistry, Manufacturing, and Controls InformationAdditional copies are available from:Office of Training and CommunicationDivision of Drug Information, HFD-240Center for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers LaneRockville, MD 20857(Tel) 301-827-4573/cder/guidance/index.htmorOffice of Communication, Training andManufacturers Assistance, HFM-40Center for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Rockville, MD 20852-1448/cber/guidelines.htm.(Tel) Voice Information System at 800-835-4709 or 301-827-1800orCommunications Staff, HFV-12Center for Veterinary MedicineFood and Drug Administration7519 Standish PlaceRockville, MD 20855(Tel) 301-827-3800/cvm/guidanc/published.htmU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Review (CBER)Center for Veterinary Medicine (CVM)January 2004CMCTABLE OF CONTENTS1I. INTRODUCTION (1)II. BACKGROUND (3)A. The Common Technical Document — Quality (CTD-Q) Format (3)B. Content of an Application (4)C. Additional Guidance (4)D. References to Other Applications or Master Files (MFs) (5)1. Other Applications (5)2. Master Files (MFs) (6)III. GENERAL INFORMATION (S.1) (8)A. Nomenclature (S.1.1) (8)B. Structure (S.1.2) (8)C. General Properties (S.1.3) (9)IV. MANUFACTURE (S.2) (10)A. Manufacturers (S.2.1) (10)B. Description of Manufacturing Process and Process Controls (S.2.2) (10)1. Flow Diagram (11)2. Description of the Manufacturing Process and Process Controls (12)3. Reprocessing, Reworking, Recycling, Regeneration, and Other Operations (15)C. Control of Materials (S.2.3) (18)1. Starting Materials (18)2. Reagents, Solvents, and Auxiliary Materials (19)3. Diluents (20)D. Controls of Critical Steps and Intermediates (S.2.4) (20)E. Process Validation and/or Evaluation (S.2.5) (23)F. Manufacturing Process Development (S.2.6) (23)V. CHARACTERIZATION (S.3) (24)A. Elucidation of Structure and Other Characteristics (S.3.1) (24)1. Elucidation of Structure (24)2. Physicochemical Characterization (25)3. Biological and Other Relevant Characteristics (26)B. Impurities (S.3.2) (27)VI. CONTROL OF DRUG SUBSTANCE (S.4) (29)1 Alphanumeric designations in parentheses that follow headings show where information should be placed in applications that are submitted in Common Technical Document (CTD) format.A. Specification (S.4.1) (29)B. Analytical Procedures (S.4.2) (34)C. Validation of Analytical Procedures (S.4.3) (35)D. Batch Analyses (S.4.4) (35)1. Batch Analysis Reports (36)2. Collated Batch Analyses Data (36)E. Justification of Specification (S.4.5) (37)VII. REFERENCE STANDARDS OR MATERIALS (S.5) (40)VIII. CONTAINER CLOSURE SYSTEM (S.6) (40)IX. STABILITY (S.7) (41)A. Stability Summary and Conclusions (S.7.1) (41)B. Postapproval Stability Protocol and Stability Commitment (S.7.2) (41)C. Stability Data (S.7.3) (41)1. Primary Stability Studies (41)2. Supporting Stability Studies (42)3. Stress Studies (42)X. APPENDICES (A) (43)A. Facilities and Equipment (A.1) (43)B. Adventitious Agents Safety Evaluation (A.2) (44)1. Nonviral Adventitious Agents (45)2. Viral Adventitious Agents (45)XI. REGIONAL INFORMATION (R) (46)A. Executed Production Records (R.1.S) (46)B. Comparability Protocols (R.2.S) (46)C. Methods Validation Package (R.3.S) (46)XII. LITERATURE REFERENCES (3.3) (47)ATTACHMENT 1: (48)STARTING MATERIALS FOR SYNTHETIC DRUG SUBSTANCES (48)ATTACHMENT 2: (56)STARTING MATERIALS OF PLANT OR ANIMAL ORIGIN (56)GLOSSARY (59)GUIDANCE FOR INDUSTRY2Drug SubstanceChemistry, Manufacturing, and Controls Information12345678910111213If you plan to submit comments on this draft guidance, to expedite FDA review of your14comments, please:15∙Clearly explain each issue/concern and, when appropriate, include a proposed revision and the rationale and/or justification for the proposed revision.1617∙Identify specific comments by line numbers; use the pdf version of the document whenever 18possible.19∙If possible, e-mail an electronic copy (Word) of the comments you have submitted to the20docket to cummingsd@.212223I. INTRODUCTION2425Information on the chemistry, manufacturing, and controls (CMC) for the drug substance must 26be submitted to support the approval of original new drug applications (NDAs), abbreviated new 27drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new28animal drug applications (ANADAs).3 This guidance provides recommendations on the CMC 29information for drug substances that should be submitted to support these applications. The30guidance is structured to facilitate the preparation of applications submitted in Common31Technical Document (CTD) format.3233This guidance addresses the information to be submitted for drug substances to ensure continued 34drug substance and drug product quality (i.e., the identity, strength, quality, purity, and potency).2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry Manufacturing andControls Coordinating Committee (CMC CC) in the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluations and Research (CBER) and the Center for Veterinary Medicine (CVM) at the FDA.3 See 21 CFR 314.50(d)(1) and 514.1(b)This guidance provides recommendations on the information that should be included for the3536following topics:37∙Nomenclature, structure, and general drug substance properties3839∙Manufacture40∙Characterization41∙Control of drug substance42∙Reference standards or materials43∙Container closure system44∙Stability45The recommendations provided in this guidance apply to the following types of drug substances:464748∙Drug substances manufactured by chemical synthesis49∙Highly purified and well characterized drug substances derived from plants or animals 4 50∙Semisynthetic drug substances manufactured by the chemical modification of a highly 51purified and well characterized intermediate derived from plants or animals52∙The synthetic portion of the manufacturing process for semisynthetic drug substances53manufactured by the chemical modification of an intermediate produced by conventional 54fermentation.5556The guidance does not provide specific recommendations relating to the following:5758∙Monoclonal antibodies59∙Peptides60∙Oligonucleotides61∙Radiopharmaceuticals62∙Medical gases63∙Drug substances that are not well characterized (e.g., botanicals, some proteins) derived 64from plants or animals65∙Drug substances derived using transgenic technology66∙Drug substances derived directly from or manufacturing operations involving67fermentation (conventional fermentation or using rDNA technology) or tissue or cell68culture.6970More detailed guidance on the content of an application may be available in separate guidance 71documents for specific types of drug substances (see section II.C). Applicants with drug72substances not specifically covered by this (Drug Substance guidance) or another guidance can 73apply the content recommendations in this guidance, as scientifically appropriate, and/or can74contact the appropriate chemistry review teams for guidance.754 For purposes of this guidance, d rug substances derived from plants or animals does not include materials producedby plant cell fermentation, animal cell or tissue culture, or through use of transgenic technology (e.g.,biotechnology-derived protein drug products).FDA’s guidance docume nts, including this guidance, do not establish legally enforceable7677responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should 78be viewed only as recommendations, unless specific regulatory or statutory requirements arecited. The use of the word should in Agency guidances means that something is suggested or7980recommended, but not required.8182This guidance, when finalized, will replace the guidance entitled Submitting Supporting83Documentation in Drug Applications for the Manufacture of Drug Substances (February 1987).848586II. BACKGROUND8788A. The Common Technical Document — Quality (CTD-Q) Format89In November 2000, the International Conference on Harmonisation of Technical9091Requirements for Registration of Pharmaceuticals for Human Use (ICH) issued92harmonized guidance for the format of drug product applications (i.e., Common93Technical Document (CTD)). The CTD describes a format for applications that94(supplemented with regional information) can be used for submission to the regulatory 95authorities in the United States, European Union, and Japan. One focus of this effort was 96harmonizing the format for quality information (i.e., chemistry, manufacturing, and97controls) that will be submitted in an application. FDA’s guidance on M4Q: The CTD —98Quality describes the format for the quality information submitted in Module 3 of an99application and provides additional information on formatting aspects of an application. 100Applicants can submit NDAs, ANDAs, NADAs, and ANADAs using the CTD-Q101format.5Applicants should review FDA’s guidance on M4Q: The CTD — Quality and 102other related CTD guidance documents for detailed formatting recommendations on103preparing an application in CTD format.104105Module 3 of each NDA and ANDA should include the specified CTD sections: Drug 106Substance (3.2.S), Drug Product (3.2.P), Appendices (3.2.A), Regional Information107(3.2.R), and Literature References (3.3). In some cases, the majority of information to 108address the drug substance sections will be incorporated by reference from a master file 109(see section II.D.2). However, an applicant should still provide information to address 110some of the drug substance subsections. Recommendations on the content of the drug 111product section (3.2.P) of Module 3 will be the provided in the guidance Drug Product —112Chemistry, Manufacturing, and Controls Information (Drug Product guidance), when 113finalized.6 The Appendices, Regional Information, and Literature References sections 114include information for both drug substance and drug product, as appropriate.1155 The information in animal drug applications is commonly presented in the order of the required CMC informationspecified under section § 514.1(b)(4) and (5). Although the CTD-Q format was developed for human drugs, thedrug substance information to support NADAs and ANADAs can be formatted according to the CTD-Q format or any alternative format that provides the appropriate information to support the application.6 A draft version of this guidance published on January 28, 2003 (68 FR 4219).116This Drug Substance guidance has been organized in a format conforming to Module 3 of 117the CTD, and it provides CMC content recommendations specific to drug substance,118including recommendations for the Appendices, Regional Information, and Literature 119References sections. Alphanumeric designations in parentheses corresponding to the 120CTD format follow relevant headings and text to show where information is to be placed 121in the CTD.7 Recommendations specific to drug product, including recommendations for 122the Appendices, Regional Information and Literature References sections, will be123provided in the Drug Product guidance.124125Multiple Drug Substances in an Application126127When an application is submitted for a drug product involving two or more drug128substances (e.g., combination drug product, copackaged drug products), information for 129each drug substance should be presented separately in the application. Information130presented separately means one complete S section for one drug substance followed by 131other complete S sections for additional drug substances. All of the information pertinent 132to each one of the drug substances (general information, manufacture, characterization, 133control, standards, container closure system, and stability) should be provided in a single 134section.135136B. Content of an Application137The application should include information in every S subsection for each of the drug 138139substances and manufacturing schemes (e.g., alternative processes, manufacturing site) 140intended for approval under the application. Information should be provided in theAppendices, Regional Information, and Literature References sections for each of the 141142drug substances and manufacturing schemes, as appropriate. If an Appendices or143Regional Information subsection or the Literature References section is not applicable, 144this should be stated in the application.145146C. Additional Guidance147148This Drug Substance guidance and the Drug Product guidance, when finalized, will be 149the primary content guidances for NDA and ANDA applicants. For quality, the general 150format guidance is M4Q: The CTD — Quality. These are the first guidances an applicant 151should consider when preparing the quality section (i.e., chemistry, manufacturing, and 152controls) of an NDA or ANDA (Module 3).153This guidance references ICH guidance documents cited in the CTD-Q and FDA’s154155guidances on general technical topics (i.e., stability, container closure systems, analytical 156procedures and methods validation, sterilization process validation, drug master files, and7 Arabic numbers have been assigned to specific sections of the CTD. For example, the designation 3.2 before S, P,A, and R indicates Module 3, Body of Data section 2. Where this guidance discusses Module 3, Body of Datasection 2, for brevity, the initial designation 3.2 is not repeated throughout the rest of the guidance (e.g., 3.2.S.1.3reads S.1.3).157environmental assessments) rather than incorporating this detailed information. These 158guidances are referenced in the text and/or listed at the end of a section. An applicant159should refer to these guidances for recommendations on the detailed information that160should be included in the application to address the general technical topic.161162Finally, an applicant should consider guidances that are available for specific technical 163issues or type (e.g., synthetic peptides) of drug substance when preparing its application. 164These guidances provide additional recommendations on unique scientific and technical 165aspects of the topic. Some references to these types of guidances are included in this166guidance. However, the references are given only as examples, and the list is not meant 167to be all-inclusive. Some examples of these types of guidance include the following:168∙Submission of Chemistry, Manufacturing, and Controls Information for Synthetic 169170Peptide Substances171∙Submission of Chemistry, Manufacturing and Controls Information for a172Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody173Product for In Vivo Use, CBER/CDER (under development)174∙Botanical Drug Products (under development)∙Fermentation Derived Drug Substances and Intermediates and Associated Drug 175176Products (under development)177∙Synthetic Oligonucleotides; Submission of Chemistry, Manufacturing, and178Controls Information (under development)179∙Radiopharmaceutical Drug Products: Chemistry, Manufacturing and ControlsInformation (under development)180181182FDA continues to update existing and publish new guidance documents. An applicant 183should use current guidance when preparing an NDA, ANDA, NADA or ANADA184submission.8185186D. References to Other Applications or Master Files (MFs)1871881. Other Applications189190In some cases, chemistry, manufacturing, and controls information about drug substances 191is provided in one application by reference to pertinent information in another application. 192This situation is less common than inclusion of information by reference to a MF and193usually occurs when the same firm submits both applications.194An applicant must identify in the application all other referenced applications, and each 195reference to information submitted in another application must identify where the196information can be found in the referenced application (21 CFR 314.50(a)(1) and197514.1(a)). If the referenced application was submitted by a firm other than the applicant,the referencing application must contain a written statement that authorizes the reference, 1988Current guidance documents are available on the Internet at /cder/guidance/index.htm,/cber/guidelines.htm, and /cvm/guidance/published.htm.199signed by the holder of the referenced application (21 CFR 314.50(g)(1), 314.420(b). and 200514.1(a)).9 Copies of letters of authorization (LOAs) should be submitted in Module 1 of 201the NDA or ANDA or in the appropriate section of an NADA or ANADA.2022032. Master Files (MFs)204205This guidance describes chemistry, manufacturing, and controls information for drug206substances that should be submitted to the Agency as part of the process of seeking theapproval of an NDA, ANDA, NADA, or ANADA. When a drug substance is207208manufactured by a firm other than the applicant, much of this information is frequently 209provided by reference to one or more Type II MFs rather than directly in an application. 210The CMC information in a Type II MF can be organized in CTD-Q format. Under FDA's 211regulations, an application can incorporate by reference all or part of the contents of any 212MF to address particular drug substance issues if the MF holder provides written213authorization (i.e., LOA) to the applicant and the authorization is included in the214application (Module 1 for an NDA or ANDA or in the appropriate section of an NADAor ANADA). The authorization must specifically identify the material being215216incorporated by reference (21 CFR 314.420 and 514.1(a)). The incorporated material217should be identified by name, reference number, volume and page number of the MF, anddate of submission. See 21 CFR 314.420, CDER’s guidance on Drug Master Files, and 218219CVM’s guidance on Preparation and Submission of Veterinary Master Files for moreinformation.220221222Both the applicant and the drug substance manufacturer (MF holder) contribute to223establishing and maintaining the identity, strength, quality, purity, and potency of the224applicant's drug products by manufacturing and controlling the drug substance in225accordance with the information submitted in the application and, by reference, in the MF. 226The following recommendations pertain to location of information in the MF and/or227application when an applicant and Type II MF holder are different firms.228229∙General Information (S.110): Both the MF and the application should include this 230information. These sections should contain similar, though not necessarily identical, 231information. For example, if an applicant performed screening studies and232established the existence of multiple polymorphs, information concerning these233polymorphs might be present in the application but not in the MF.234235∙Manufacture (S.2): The application should identify in S.2.1 the manufacturers of 236each drug substance with appropriate administrative information (see section IV.A). 237The MF should include this information for its manufacturing operations and any9 CVM discourages the reference of NDAs or ANDAs for drug substance information. In these instances, CVMrecommends that the drug substance information be included in a master file or incorporated in the applicant’sNADA or ANADA.10 Alphanumeric designations in parentheses that follow headings show where information should be placed inapplications that are submitted in Common Technical Document (CTD) format.238contract facilities that are used (e.g., intermediate manufacturers, laboratories). In239general, a MF can be referenced for the information recommended in S.2.2 through240S.2.6. However, the information should be augmented by the applicant, as241appropriate. For example, if the applicant micronizes drug substance purchased from242a MF holder the information on the micronization process should be included in the243application.244245∙Characterization (S.3): In general, a MF can be referenced for this information.However, the information should be augmented by the applicant, as appropriate. For 246247example, characterization information on physical properties critical to the applicant’s248product, such as solid state form or particle size distribution, should be included in249S.3.1 by the applicant under certain circumstances (e.g., applicant manipulates the250physical property (micronizes), the MF holder has not characterized the physical251property). Furthermore, information on an applicant’s studies to characterizeimpurities (S.3.2) can be warranted to support the applicant’s drug substance controls. 252253254∙Control of Drug Substance (S.4): In general, information recommended in S.4 should be provided in both the MF and the application. However, reference to an MF 255256can be appropriate for some of the information in S.4.2 through S.4.5 if the MF257holder and applicant are working together to develop the drug substance controls.Both the MF and the application should include a drug substance specification (S.4.1). 258259The MF could include more than one drug substance specification if the holder sellsdifferent technical grades of the drug substance (e.g., micronized and nonmicronized). 260261262∙Reference Standards (S.5): In general, information should be provided in both the 263MF and the application. However, reference to a MF can be appropriate for some of264the information if the MF holder and applicant are working together to develop the265reference standard.266267∙Container Closure System (S.6): In general, MFs can be referenced for this268information. However, the information should be augmented by the applicant, as269appropriate.270271∙Stability (S.7): In general, MFs can be referenced for this information. However, the information should be augmented by the applicant, as appropriate. For example, 272273an applicant might perform stress studies to support the analytical procedures it used274to control the drug substance.275276∙Appendices (A): In general, MFs can be referenced for this information. However, 277the information should be augmented by the applicant, as appropriate.278279∙Regional Information (R): Comparability protocols can be included in both the MF 280and application (R.2.S). A methods validation package should be included in theapplication (R.3.S).281282∙Literature References (3.3): Both the MF and the application should include283284literature references as warranted.285Type II MFs for drug substance intermediates can also be submitted in the CTD-Q format. 286287However, not all sections of the CTD-Q format would apply (e.g., S.4). The CMC288information provided to support an intermediate should be appropriate for the particularsituation (e.g., process, complexity of the molecule).289290291III. GENERAL INFORMATION (S.1)292293294General information on the nomenclature, structure, and general properties of the drug substance, should be provided in S.1.295296297A. Nomenclature (S.1.1)298299All appropriate names or designations for the drug substance should be provided in S.1.1. 300Any codes, abbreviations, or nicknames used in the application to identify the drug301substance should also be listed, including the following, if they exist or have been302proposed. A name that has not yet been finalized should be identified as proposed in the 303list.304305∙United States Adopted Name (USAN)∙Compendial name11306307∙Chemical names (e.g., Chemical Abstracts Service (CAS), International Union of 308Pure and Applied Chemistry (IUPAC))∙Company names or laboratory codes309310∙Other nonproprietary names (e.g., International Nonproprietary Name (INN),311British Approved Name (BAN), Japanese Accepted Name (JAN))312∙Chemical Abstracts Service (CAS) Registry Number313314B. Structure (S.1.2)315316Information on the chemical structure of the drug substance should be provided in S.1.2. 317This information should include:318319∙one or more drawings to show the overall chemical structure of the drug substance, 320including stereochemistry321∙molecular formula322∙molecular weight323324For a naturally derived protein drug substance, the information should include:11 A compendial name is a name that appears in an official compendium as defined in the Federal Food, Drug, andCosmetic Act (e.g., United States Pharmacopeia (USP)) (§ 201(j) (21 U.S.C. 32(i)).325326∙the schematic amino acid sequence indicating glycosylation sites or other327posttranslational modifications∙ a general description of the molecule (e.g., shape, disulfide bonds, subunit328329composition)330∙number of amino acid residues331∙molecular weight332333C. General Properties (S.1.3)334A list should be provided of the general physicochemical properties of the drug substance. 335336Other relevant properties of the drug substance should also be listed. Relevant properties 337are those physical, chemical, biological and microbiological attributes relating to theidentity, strength, quality, purity, and/or potency of the drug substance and, as338339appropriate, drug product. The information should include, as appropriate:340341∙ A general description (e.g., appearance, color, physical state)342∙Melting or boiling points343∙Optical rotation344∙Solubility profile (aqueous and nonaqueous, as applicable)345∙Solution pH346∙Partition coefficients347∙Dissociation constants348∙Identification of the physical form (e.g., polymorph, solvate, or hydrate) that will 349be used in the manufacture of the drug product350∙Biological activities351352For a naturally derived protein drug substance, additional information should be included, 353such as:354355∙Isoelectric point356∙Extinction coefficient357∙Any unique spectral characteristics358359If the drug substance can exist in more than one physical form, the information included 360in S.1.3 should be for the form (or forms) of the drug substance that will be used in the 361manufacture of the drug product. Detailed information on the characterization (e.g., X-362ray powder diffraction data, thermal analysis curves) of these and other physical forms 363and conditions required to produce one form or another should be provided in S.3.1.364。
冀教版英语初一上学期期中试卷与参考答案(2024-2025学年)
2024-2025学年冀教版英语初一上学期期中复习试卷与参考答案一、听力部分（本大题有20小题，每小题1分，共20分）1、听力材料：A. This is my cat. It’s black and white.B. That is my dog. It’s brown and white.Question: What color is the speaker’s cat?A. Black and whiteB. Brown and whiteAnswer: AExplanation: The speaker clearly mentions, “This is my cat. It’s black and white,” which indicates the cat is black and white.2、听力材料：A. I have a new book. It’s about history.B. She has a new bike. It’s red.Question: What does the speaker have that is red?A. A new bookB. A new bikeAnswer: BExplanation: The speaker states, “She has a new bike. It’s red,” which directly answers the question about something red that the speaker has.3、Listen to the dialogue and answer the question.A. What is the weather like today?B. How do they feel about the weather?C. What are they planning to do?Answer: BExplanation: In the dialogue, one person asks how the other person feels about the weather, indicating a question about their feelings towards the weather, not about the weather itself or their plans.4、Listen to the short passage and choose the best answer to the question.What is the main topic of the passage?A. The importance of exerciseB. Different types of sportsC. The benefits of playing outdoor gamesAnswer: CExplanation: The passage focuses on the benefits of playing outdoor games, which is the main topic discussed throughout the passage. The other options, while related to the content of the passage, are not the central focus.5、听力原文：W: Excuse me, where is the nearest post office?M: It’s on the other side of the street. You can see a big sign that says “Post Office” there.Question: Where is the nearest post office?A. On this side of the street.B. On the other side of the street.C. Across the street.D. Behind the big building.Answer: BExplanation: The man says, “It’s on the other side of the street,” which means the nearest post office is located on the opposite side of the street.6、听力原文: M: Hi, Jane. I heard you won the math competition. Congratulations!W: Thank you, Tom. I worked really hard for it. How about you? What’s your favorite subject?M: Well, my favorite subject is science. I find it very interesting and I love doing experiments.Question: What is Jane’s favorite subje ct?A. ScienceB. MathC. EnglishD. HistoryAnswer: BExplanation: Jane responds to Tom’s compliment by saying, “Thank you, Tom.I worked really hard for it,” which indicates that she won the math competition.Therefore, her favorite subject is Math.7、You are listening to a conversation between a student and a teacher.Student: Good morning, Mr. Wang. How was your weekend?Teacher: Oh, it was quite nice. I went hiking with my family. How about you?Student: I stayed at home and watched some movies.Teacher: That sounds relaxing. Did you learn anything new this weekend?Student: Yes, actually. I watched a documentary about space exploration. It was fascinating!Teacher: That’s great. Learning something new is always good. Well, let’s get back to our English class.Question: What did the student do over the weekend?A) He went hiking.B) He stayed at home.C) He went shopping.D) He visited his friends.Answer: B) He stayed at home.解析：根据对话内容，学生回答说他在家看电影，所以选项B是正确答案。
2022软件水平考试真题英语汇总
2022软件水平考试真题英语汇总全文共3篇示例，供读者参考篇12022 Software Skill Exam English Question SummaryIntroduction:The 2022 Software Skill Exam is an important assessment for individuals in the software development field to showcase their knowledge and expertise. This article will provide a summary of the English questions asked in the exam to help candidates prepare for future assessments.Question 1:Choose the correct form of the verb to complete the sentence:The team (is/are) working on a new software project that (require/requires) innovative solutions.Answer:The team is working on a new software project that requires innovative solutions.Question 2:Fill in the blank with the appropriate preposition:The software developer is responsible (for/on) testing the new application before its release.Answer:The software developer is responsible for testing the new application before its release.Question 3:Rewrite the sentence using the passive voice:The software engineer will complete the project by next week.Answer:The project will be completed by the software engineer by next week.Question 4:Choose the correct conjunction to join the two sentences:The software update is scheduled for tomorrow. The development team is still working on fixing bugs.Answer:The software update is scheduled for tomorrow, but the development team is still working on fixing bugs.Question 5:Read the paragraph and answer the questions:"Software testing is a crucial step in the development process. It ensures that the application meets the desired standards of quality and functionality. Without proper testing, software could contain bugs and malfunctions that impact user experience."Questions:1. What is the purpose of software testing?2. What could happen if software is not adequately tested?Answer:1. The purpose of software testing is to ensure that the application meets the desired standards of quality and functionality.2. If software is not adequately tested, it could contain bugs and malfunctions that impact user experience.Conclusion:The English questions in the 2022 Software Skill Exam are designed to test candidates' understanding of grammar, vocabulary, and comprehension. By practicing with these sample questions, individuals can improve their language skills and perform better in future assessments. Good luck with your exam preparation!篇22022 Software Proficiency Exam English Questions Compilation1. What is the difference between digital and analog signals in the context of computer science?2. Explain the concept of object-oriented programming and provide examples of programming languages that support this paradigm.3. Discuss the importance of data structures in computer programming and provide examples of commonly used data structures.4. What is the role of algorithms in software development? How do developers choose the most suitable algorithm for a given problem?5. Describe the process of software testing and explain the different types of testing methods used in the industry.6. What are the key differences between front-end and back-end development? Provide examples of technologies used in each area.7. Discuss the concept of cloud computing and its impact on the software industry. How has cloud technology revolutionized the way software is developed and deployed?8. Explain the principles of secure coding and discuss the importance of incorporating security measures in software development.9. What are the advantages and disadvantages of using open-source software in a development project? How can developers address potential challenges associated withopen-source solutions?10. Discuss the role of artificial intelligence and machine learning in software development. How do these technologies enhance the capabilities of software applications?These are just a few examples of the types of questions that may appear on the 2022 Software Proficiency Exam. Test-takers are encouraged to study a wide range of topics related to software development, programming languages, data structures, and industry trends to ensure success on the exam. Good luck!篇32022 Software Proficiency Exam English Test CompilationIn today's technological world, software proficiency is a valuable skill that can open up many opportunities for individuals in various industries. Whether you are a programmer, designer, or analyst, having a strong command of software applications is crucial for success. To assess the level of software proficiency among professionals, the 2022 Software Proficiency Exam was conducted, with an English test being one of the components of the examination.Below are a compilation of some of the actual English test questions from the 2022 Software Proficiency Exam:1. Define the term "software engineering" and explain its importance in the development of software applications.2. Discuss the differences between waterfall and agile software development methodologies. Which approach do youthink is more effective in today's fast-paced business environment?3. Describe the concept of software testing and its significance in ensuring the quality of software products. Provide examples of different types of software testing methodologies.4. What are the common programming languages used in software development? Compare and contrast the features of Java, Python, and C++.5. Explain the role of version control systems in software development. How do tools like Git and SVN help developers collaborate and manage code changes effectively?6. Discuss the principles of object-oriented programming and how they are implemented in languages like Java and C++. Provide examples of classes, objects, and inheritance in your explanation.7. How does cybersecurity play a critical role in the development of secure software applications? List and explain some best practices for ensuring data protection and privacy in software systems.8. Describe the process of software deployment and the challenges involved in releasing new software versions to users.How can continuous integration and continuous deployment (CI/CD) pipelines help streamline the deployment process?9. Discuss the importance of user experience (UX) design in software development. How can UX principles like usability, accessibility, and aesthetics enhance the overall user satisfaction with software products?10. In your opinion, what are the upcoming trends and technologies in the field of software development? How can professionals stay updated with the latest advancements in programming languages, frameworks, and tools?These are just a few examples of the English test questions that were included in the 2022 Software Proficiency Exam. By answering these questions, candidates were able to demonstrate their knowledge and expertise in software development, programming languages, testing methodologies, cybersecurity, and user experience design.Overall, the Software Proficiency Exam served as a benchmark for assessing the skills and competencies of professionals in the software industry. It provided a comprehensive evaluation of candidates' capabilities in various aspects of software development, highlighting the importance of continuous learning and growth in this dynamic field.As technology continues to evolve, it is essential for professionals to stay updated with the latest trends and tools in software engineering. By mastering software proficiency skills and staying abreast of industry developments, individuals can enhance their career prospects and contribute to the innovation and growth of the software industry.In conclusion, the 2022 Software Proficiency Exam English test served as a valuable assessment tool for evaluating candidates' expertise in software development and related disciplines. It emphasized the importance of software proficiency skills in today's competitive job market and encouraged professionals to strive for excellence in their careers.。
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Evaluation of an ITS for the Passive Voice of the English LanguageUsing the CIAO! FrameworkMaria Virvou, Victoria Tsiriga, Dimitris MarasDepartment of Informatics,University of Piraeus,Piraeus 18534, GreeceE-mail: mvirvou @unipi.gr, vtsir@unipi.gr, eagle@ath.fothnet.grIntroductionThe primary aim of educational software is to help students learn. Therefore, evaluation of this kind of software is crucial. Its aim is to test the functionality and usability of the design and to identify and rectify any problems (Dix et al. 1993). In particular, formative evaluation is one of the most critical steps in the development of learning materials because it helps the designer improve the cost-effectiveness of the software and this increases the likelihood that the final product will achieve its stated goals (Chou 1999). In this paper, we present and discuss the evaluation of an intelligent tutoring system for the passive voice of the English language using the CIAO! framework (Jones et al. 1999).The Passive Voice TutorThe tutoring system that we developed and evaluated is called Passive Voice Tutor (Virvou & Maras 1999a; 1999b). The Passive Voice Tutor complies with the architecture of most ITSs, which consists of the domain knowledge, the student modeller, the advice generator and the user interface (Wenger 1987).In particular, the domain knowledge of the Passive Voice Tutor comprises knowledge about how to convert a sentence from active to passive voice and vice versa. It also provides the knowledge needed for the dynamic construction of new exercise sentences. Finally, it comprises knowledge about the semantic relation between the words used for the construction of new sentences.The student modeller checks the student’s answer and in case of error, it performs error diagnosis. It contains a bug library of the most common student errors and generic mal-rules that students often apply when they have misconceptions. Another responsibility of the student modeller is to keep a history record concerning each student’s progress in learning. This record is used in cases were ambiguity arises, so that the system attributes a particular error to a category of errors that the student seems to be prone to.The advice generator is responsible for responding in the most appropriate way to a student’s error, by informing the user about the cause of the error and by showing to him/her the relevant part of the theory. Finally, the user interface of the Passive Voice Tutor, is a multimedia user interface, which involves animations, sounds and a limited form of natural language so that it can attract the student’s interest.The EvaluationThe CIAO! framework outlines three dimensions to evaluate: (i) context; (ii) interactions; and (iii) attitudes and outcomes. One important aspect of context is the reason why CAL is adopted in the first place, i.e. the underlying rationale for its development and use; different rationales require different evaluation approaches. According to the framework, the reason for looking at students’ interactions with the software is in order to understand more about their learning processes; such interactions can provide protocol data for later analysis. Finally, at the “outcomes” stage, information from a variety of sources needs to be used including, pre and post-achievement tests, interviews and questionnaires with students and tutors. The overall emphasis of this framework is on educational issues.There are many other evaluation techniques, such as the JIGSAW model (Squire & Preece 1996) or the ‘set of learning with software heuristics’ (Squires & Preece 1999), which also address the problem of integrating both usability and learning issues in the evaluation of educational software. In the JIGSAW model, the evaluation is performed in three levels. In Level 1, the subtasks of the learning and operational tasks are considered independently of each other. As we move from Level 1 to Level 2, integration within the learning and the operational tasks is considered. At Level 3 integration between the learning and operational tasks is considered. On the other hand, the set of ‘learning with software’ heuristics, are an adaptation of the “usability heuristics” presented in Nielsen (1994), so as to relate them to socio-constructivist criteria for learning. These heuristics include the need to consider appropriate levels oflearner control, the need for the prevention of peripheral cognitive errors and the need for strategies for the cognitive error recognition, diagnosis and recovery cycle. The CIAO! framework, seemed to be a more suitable method, in the sense that it also evaluated the students’ use of the resource package.For the evaluation along the dimensions of the CIAO! framework, presented above, we have done the following:i) Context: The underlying rationale for the development and use of the Passive Voice Tutor is to helpstudents during the process of learning. Hence, one of the primary aims of the system is to address individual learners’ misconceptions and help them correct their errors. Evaluation in terms of the context has been addressed by questionnaires to human tutors before their students had ever used the system. This was done so that the domain knowledge and student modeller could be evaluated. In particular, tutors were given a set of erroneous answers to questions relating to the domain, which were generated using the system’s domain knowledge and bug library. For each question, each tutor had to provide an explanation as to what s/he thought the underlying misconception of the error was. Each human tutor’s explanation was compared to the Passive Voice Tutor’s explanation. A satisfactory degree of compatibility was found (45%). However, the comparisons also showed that the explanations could be improved at a later version of the Passive Voice Tutor.ii) Interactions: On a second phase, tutors were asked to evaluate the system, after their students had interacted with the Passive Voice Tutor. Protocol data was collected through the individual long term user model of each student. This kind of protocol data was first automatically analysed by the student modeller and resulted in information that concerned the student’s individual way of learning. Then, human tutors were also given the same set of students’ protocols and were asked to analyse them.Finally the tutors’ analysis was compared to the system’s analysis. To a large extent, human tutors had similar beliefs to the system’s beliefs about the students who took part in this evaluation stage.iii) Attitudes and Outcomes: In the case of the Passive Voice Tutor, at the outcomes stage, questionnaires were given to students and tutors. Students’ questions included the following: “Did you consider the system responses to your errors helpful for understanding your mistakes?” Tutors were also asked to evaluate the outcome of the use of the system, after their students had interacted with the Passive Voice Tutor. Therefore, the teachers were asked to provide information about whether the software helped them to understand better the difficulties that their students had in learning the passive voice of the English language. Tutors also seemed quite satisfied by the system’s student modelling component.Finally, the progress statistics of each student that had been recorded in his/her long term student model was also used at this stage of the evaluation. The analysis of this kind of data showed that the majority of students (57%) made a progress in their learning, whereas only 43% did not seem to have any progress in their learning of the passive voice. This is an encouraging result in terms of the educational effectiveness of the system.ConclusionsThe CIAO! framework for evaluating educational software has provided insight for several aspects of the software that needed evaluation at several stages; e.g. before any student had interacted with the software and after. In this way, both learning effects and usability issues could be evaluated. 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