IC培训
   
 
 
     班.级.规.模--热线:4008699035 手机:15921673576/13918613812( 微信同号)
         坚持小班授课,为保证培训效果,增加互动环节,每期人数限3到5人。
     上.课.时.间.和.地.点
  上课地点:【上海】:同济大学(沪西)/新城金郡商务楼(11号线白银路站) 【深圳分部】:电影大厦(地铁一号线大剧院站)/深圳大学成教院 【北京分部】:北京中山/福鑫大楼 【南京分部】:金港大厦(和燕路) 【武汉分部】:佳源大厦(高新二路) 【成都分部】:领馆区1号(中和大道) 【沈阳分部】:沈阳理工大学/六宅臻品 【郑州分部】:郑州大学/锦华大厦 【石家庄分部】:河北科技大学/瑞景大厦 【广州分部】:广粮大厦 【西安分部】:协同大厦
近开课时间(周末班/连续班/晚班):2021年10月3日(欢迎您垂询,视教育质量为生命!)
     实验设备
       ☆资深工程师授课
        
        ☆实战,实战,还是实战!

        ☆推荐工作
        ★实验设备请点击这儿查看★
     质量保障
 

        1.免费重修;
        2、课程完成后,授课老师留给学员手机和Email,保障培训效果,免费提供半年的技术支持。
        3、培训合格学员可享受免费推荐就业机会。

 
课程大纲
   
 
  • 课程介绍
    Certified Clinical Research Coordinators (CCRCs) are expected to have general knowledge of:
         • laboratory terminology, tests, and procedures
         • basic math, including adding, subtracting, multiplying, dividing, and calculating percentages
         As defined by the 2010 ACRP Job Analysis Survey, a Certified Clinical Research Coordinator (CCRC®) shall have proficiency in the following areas of clinical research:

  • 课程大纲:

            I. Investigational Product Management
            •  Ensure adequacy of investigational product and other supplies at site
            • Ensure randomization and emergency codes of investigational product have been maintained
            • Ensure proper storage, dispensing, handling, and disposition of investigational product and other supplies
            • Reconcile investigational product and other supplies
            • Maintain accountability of investigational product
            • Prepare investigational product according to the protocol
            • Dispense investigational product according to the protocol
            • Retrieve investigational product and calculate subject compliance
            • Maintain randomization and emergency codes of investigational product dispensing
            • Prepare emergency use report
            Using knowledge of:
            • Investigational product (e.g., package insert, report of prior investigations, Investigator's Brochure)
            • Investigational product inventory
            • Investigational product accountability
            • Investigational product storage
            • Packaging and labeling
            • Supplemental/rescue/comparator product
            • Investigational product compliance (e.g., protocol, standard operating procedures, local governance)
            • Accountability records
         II. Protocol
            • Evaluate protocol for feasibility
            • Evaluate congruence of data collection tools (e.g., case report form (CRF), electronic data capture (EDC) with the study protocol
            • Verify the eligibility of potential trial subjects
            • Contribute to protocol development
            • Coordinate protocol approval process
            • Review protocol for feasibility
            • Review protocol during Investigator’s meeting
            • Execute study per protocol
            • Recommend and Implement protocol amendments
            Using knowledge of:
            • Protocol development
            • Protocol submission and approval procedures
            • Clinical trial phase
            • Study design characteristics (e.g., double‐blind, crossover, randomized)
            • Study objective
            • Description of procedures
            • Amendment submission and approval procedures
            • Inclusion/exclusion criteria
            • Statistical plan
         III. Safety
            • Assess safety during trial participation
            • Minimize potential risks to subject safety
            • Oversee safety risks (e.g., clinical holds, product recalls)
            • Report required adverse events to regulatory authorities and/or IRB/IEC
            • Ensure adverse events reporting is documented (e.g., serious, severe, moderate, mild, expected, unexpected)
            • Ensure reasons for subject discontinuation are documented (i.e., causes, contact efforts)
            • Handle medical monitor oversight
            • Conduct study‐related procedures and monitor the safety of the trial subjects and investigational staff
            • Manage and motivate the investigational staff and other disciplines involved, and take measures to minimize any potential risks
            • Inform the sponsor and IRB/IEC of any changes to the protocol or safety concerns and submit progress reports to the IRB/IEC per requirements
            • Review common laboratory values and alerts
            • Determine and document the causality of adverse events
            • Identify expected or unexpected results associated with investigational products
            • Implement Investigator’s plan of action for management of adverse event (e.g., stop investigational product; call, retest, treat subject)
            • Maintain follow‐up to determine resolution of adverse event
            • Report serious adverse event to Sponsor/CRO and IRB/IEC
            • Classify adverse events (i.e., serious, severe, moderate, mild, expected, unexpected)
            • Record adverse event and relevant information on source document
            • Document reasons for subject discontinuation (i.e., causes, contact efforts)
            • Document follow‐up medical care for study subjects, as applicable
            • Conduct safety monitoring/reporting activities
            • Initiate un‐blinding procedures
            Using knowledge of:
            • Investigator’s Brochure
            • Safety monitoring
            • Safety and clinical databases
            • Subject safety issues (e.g., toxicity, significant lab values)
            • Adverse events reporting
            • Serious adverse events reporting
            • Safety reporting requirements
         IV. Trial Management
            • Verify investigator/site feasibility
            • Develop timelines for conducting and completing the clinical trial
            • Prepare and conduct initiation activities
            • Ensure appropriate training of the investigational staff
            • Develop a recruitment strategy and study management plan
            • Follow a recruitment strategy and study management plan
            • Schedule and coordinate pre‐study site visit
            • Identify minimum regulatory document requirements for site trial master file (e.g., country‐specific regulatory documents)
            • Ensure IRB/IEC review/approval of study and study documents
            • Facilitate site budget/contract approval process
            • Submit documents to regulatory authorities
            • Document and communicate site visit findings
            • Ensure clinical trial registry requirements are met
            • Ensure timely review of study data (e.g., laboratory results, x‐rays)
            • Maintain current vendor credentials (e.g., lab certification/licensure and normal ranges)
            • Prepare and conduct close‐out monitoring visit(s)
            • Prepare study summary and/or close‐out letter for IRB/IEC
            • Document protocol deviations/violations
            • Evaluate study for feasibility
            • Schedule subjects
            • Obtain informed consent and screen trial subjects
            • Prepare study documents for IRB/IEC and/or sponsor review/approval
            • Prepare study documentation (e.g., schedule of events, description of procedures)
            • Train site personnel on Sponsor/CRO and regulatory requirements for study conduct (e.g., protocol procedures, EDC)
            • Select the investigational staff and assign roles and responsibilities
            • Develop a recruitment strategy and site study management plan
            • Transmit CRFs to Data Management
            • Review CRF queries from Data Management
            • Coordinate study monitoring visits
            • Select and manage local vendors (e.g., laboratory, x‐ray, MRI)
            • Draft study specific tools (e.g., source document, tracking tools)
            • Obtain, negotiate, and seek approval of study budgets and clinical trial agreement
            • Conduct subject visits according to requirements
            • Implement corrective actions plans
            • Maintain trial master file (e.g., regulatory binder)
            • Communicate laboratory/diagnostic results with Principal Investigator and Sponsor/CRO
            • Maintain standards for handling hazardous goods (e.g., IATA)
            • Manage study supplies (e.g., lab kits, case report forms)
            • Maintain equipment (e.g., calibration and preventive maintenance)
            • Manage study record retention and availability
            • Manage financial agreements
            • Comply with subject privacy regulations
            • Prescreen telephone calls for eligibility requirements
            • Maintain subject screening/enrollment log
            • Collect, record, and report accurate and verifiable data
            • Manage study issues
            Using knowledge of:Site Activities
            • Contract budget negotiations and approval process
            • Monitoring guidelines/plan and tools
            • Disposition of unused study‐related materials (e.g., CRF at end of study, destruction of lab kits)
            • Equipment and supplies (e.g., x‐ray, computer, lab kits) and storage
            • Pre‐study site visit
            • Investigator's meeting
            • Site initiation
            • Monitoring visit
            • Close‐out visit
            • Site monitoring visit log
            • Site signature log
            • Delegation listing
            • Trial master file (e.g., site, sponsor)
            • Regulatory documents
            • Record retention
            • Visit reports (e.g., initiation, close‐out)
            • Final report
            • Progress reports
            Protocol Compliance
            • Project feasibility
            • Study project tools
            • Sample collection, shipment, and storage
            • Study management plan (e.g., timelines, data management)
            • Good Clinical Practice
            • Procedure manuals
            • Protocol deviations
            Subject Scheduling, Screening, Recruitment, and Retention
            • Project timelines
            • Recruitment plan/strategies
            • Subject compliance
            • Subject visit logistics
            • Subject selection, screening, and recruitment
            • Subject retention
            • Subject discontinuation
            • Clinical trial registry
            PI Oversight/Qualifications
            • Staff qualifications
            • Staff roles and responsibilities
            • Plan for staff oversight
            • Investigator qualifications/site selection (e.g., therapeutic area, education, experience)
            • Plan for ancillary staff education
            CRF/Source Documents
            • Data management activities
            • Communication documentation (e.g., telephone, email)
            • Data management plan
            • Data query resolution
            • Electronic data (e.g., electronic health records, electronic case report forms)
            • Case Report Form
            • Essential documentation, subject related and non‐subject related (e.g., past medical records, lab reports, protocol, IRB approvals)
            • Source documentation
            Consent/Assent
            • Vulnerable subject populations
            • Communication with subjects
            • Protection of human subjects
            • Subject reimbursement
            • Subject privacy regulations
            • Informed consent
            • Indemnification/insurance
         V. Trial Oversight
            • Ensure consistency between the sites’ standard operation procedures (SOPs) and the study requirements
            • Ensure investigator/site protocol compliance
            • Facilitate investigator/site corrective actions
            • Ensure compliance with electronic data requirements (e.g., electronic health records, eCRF)
            • Ensure adequate site management
            • Prepare the study site for audits and inspections
            • Respond to or facilitate response to audit/inspection findings
            • Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation of slides, freezing, refrigeration)
            • Ensure proper adverse event reporting by the investigator
            • Escalate problems to appropriate in‐house management
            • Investigate potential fraud and misconduct
            • Report potential fraud and misconduct
            • Ensure follow‐up medical care for study subjects is documented, as applicable
            • Ensure adequate consent and documentation
            • Ensure staff, facility, and equipment availability throughout the study
            • Ensure compliance with study requirements and regulations
            • Prepare for audits, inspections, and follow up
            • Ensure access to source data by authorized parties, in accordance with ICH‐GCP, and protect confidentiality by limiting unauthorized access
            • Ensure that IRB/IEC documentation is adequate and that details of the IRB/IEC composition are on file
            Using knowledge of:
            • Issues management (e.g., escalation)
            • Audit preparation
            • Regulatory standards
            • Audit documents
            • Project monitoring guidelines
            • Project investigator supervision requirements

 

曙海教育实验设备
android开发板
linux_android开发板
fpga图像处理
曙海培训实验设备
fpga培训班
 
本课程部分实验室实景
曙海实验室
实验室
曙海培训优势
 
  合作伙伴与授权机构



Altera全球合作培训机构



诺基亚Symbian公司授权培训中心


Atmel公司全球战略合作伙伴


微软全球嵌入式培训合作伙伴


英国ARM公司授权培训中心


ARM工具关键合作单位
  我们培训过的企业客户评价:
    曙海的andriod 系统与应用培训完全符合了我公司的要求,达到了我公司培训的目的。 特别值得一提的是授课讲师针对我们公司的开发的项目专门提供了一些很好程序的源代码, 基本满足了我们的项目要求。
——上海贝尔,李工
    曙海培训DSP2000的老师,上课思路清晰,口齿清楚,由浅入深,重点突出,培训效果是不错的,
达到了我们想要的效果,希望继续合作下去。
——中国电子科技集团技术部主任 马工
    曙海的FPGA 培训很好地填补了高校FPGA培训空白,不错。总之,有利于学生的发展, 有利于教师的发展,有利于课程的发展,有利于社会的发展。
——上海电子,冯老师
    曙海给我们公司提供的Dsp6000培训,符合我们项目的开发要求,解决了很多困惑我 们很久的问题,与曙海的合作非常愉快。
——公安部第三研究所,项目部负责人李先生
    MTK培训-我在网上找了很久,就是找不到。在曙海居然有MTK驱动的培训,老师经验 很丰富,知识面很广。下一个还想培训IPHONE苹果手机。跟他们合作很愉快,老师很有人情味,态度很和蔼。
——台湾双扬科技,研发处经理,杨先生
    曙海对我们公司的iPhone培训,实验项目很多,确实学到了东西。受益无穷 啊!特别是对于那种正在开发项目的,确实是物超所值。
——台湾欧泽科技,张工
    通过参加Symbian培训,再做Symbian相关的项目感觉更加得心应手了,理 论加实践的授课方式,很有针对性,非常的适合我们。学完之后,很轻松的就完成了我们的项目。
——IBM公司,沈经理
    有曙海这样的DSP开发培训单位,是教育行业的财富,听了他们的课,茅塞顿开。
——上海医疗器械高等学校,罗老师
  我们新培训过的企业客户以及培训的主要内容:
 

一汽海马汽车 DSP培训
苏州金属研究院 DSP培训
南京南瑞集团技术 FPGA培训
西安爱生技术集团 FPGA培训,DSP培训
成都熊谷加世电气 DSP培训
福斯赛诺分析仪器(苏州) FPGA培训
南京国电工程 FPGA培训
北京环境特性研究所 达芬奇培训
中国科微系统与信息技术研究所 FPGA高级培训
重庆网视只能流技术开发 达芬奇培训
无锡力芯微电子股份 IC电磁兼容
河北科研究所 FPGA培训
上海微小卫星工程中心 DSP培训
广州航天航空 POWERPC培训
桂林航天工 DSP培训
江苏五维电子科技 达芬奇培训
无锡步进电机自动控制技术 DSP培训
江门市安利电源工程 DSP培训
长江力伟股份 CADENCE 培训
爱普生科技(无锡 ) 数字模拟电路
河南平高 电气 DSP培训
中国航天员科研训练中心 A/D仿真
常州易控汽车电子 WINDOWS驱动培训
南通大学 DSP培训
上海集成电路研发中心 达芬奇培训
北京瑞志合众科技 WINDOWS驱动培训
江苏金智科技股份 FPGA高级培训
中国重工第710研究所 FPGA高级培训
芜湖伯特利汽车安全系统 DSP培训
厦门中智能软件技术 Android培训
上海科慢车辆部件系统EMC培训
中国电子科技集团第五十研究所,软件无线电培训
苏州浩克系统科技 FPGA培训
上海申达自动防范系统 FPGA培训
四川长虹佳华信息 MTK培训
公安部第三研究所--FPGA初中高技术开发培训以及DSP达芬奇芯片视频、图像处理技术培训
上海电子信息职业技术--FPGA高级开发技术培训
上海点逸网络科技有限公司--3G手机ANDROID应用和系统开发技术培训
格科微电子有限公司--MTK应用(MMI)和驱动开发技术培训
南昌航空大学--fpga 高级开发技术培训
IBM 公司--3G手机ANDROID系统和应用技术开发培训
上海贝尔--3G手机ANDROID系统和应用技术开发培训
中国双飞--Vxworks 应用和BSP开发技术培训

 

上海水务建设工程有限公司--Alter/Xilinx FPGA应用开发技术培训
恩法半导体科技--Allegro Candence PCB 仿真和信号完整性技术培训
中国计量--3G手机ANDROID应用和系统开发技术培训
冠捷科技--FPGA芯片设计技术培训
芬尼克兹节能设备--FPGA高级技术开发培训
川奇光电--3G手机ANDROID系统和应用技术开发培训
东华大学--Dsp6000系统开发技术培训
上海理工大学--FPGA高级开发技术培训
同济大学--Dsp6000图像/视频处理技术培训
上海医疗器械高等专科学校--Dsp6000图像/视频处理技术培训
中航工业无线电电子研究所--Vxworks 应用和BSP开发技术培训
北京交通大学--Powerpc开发技术培训
浙江理工大学--Dsp6000图像/视频处理技术培训
台湾双阳科技股份有限公司--MTK应用(MMI)和驱动开发技术培训
滚石移动--MTK应用(MMI)和驱动开发技术培训
冠捷半导体--Linux系统开发技术培训
奥波--CortexM3+uC/OS开发技术培训
迅时通信--WinCE应用与驱动开发技术培训
海鹰医疗电子系统--DSP6000图像处理技术培训
博耀科技--Linux系统开发技术培训
华路时代信息技术--VxWorks BSP开发技术培训
台湾欧泽科技--iPhone开发技术培训
宝康电子--Allegro Candence PCB 仿真和信号完整性技术培训
上海天能电子有限公司--Allegro Candence PCB 仿真和信号完整性技术培训
上海亨通光电科技有限公司--andriod应用和系统移植技术培训
上海智搜文化传播有限公司--Symbian开发培训
先先信息科技有限公司--brew 手机开发技术培训
鼎捷集团--MTK应用(MMI)和驱动开发技术培训
傲然科技--MTK应用(MMI)和驱动开发技术培训
中软国际--Linux系统开发技术培训
龙旗控股集团--MTK应用(MMI)和驱动开发技术培训
研祥智能股份有限公司--MTK应用(MMI)和驱动开发技术培训
罗氏诊断--Linux应用开发技术培训
西东控制集团--DSP2000应用技术及DSP2000在光伏并网发电中的应用与开发
科大讯飞--MTK应用(MMI)和驱动开发技术培训
东北农业大学--IPHONE 苹果应用开发技术培训
中国电子科技集团--Dsp2000系统和应用开发技术培训
中国船舶重工集团--Dsp2000系统开发技术培训
晶方半导体--FPGA初中高技术培训
肯特智能仪器有限公司--FPGA初中高技术培训
哈尔滨大学--IPHONE 苹果应用开发技术培训
昆明电器科学研究所--Dsp2000系统开发技术
奇瑞汽车股份--单片机应用开发技术培训


 

        Troubleshooting Java Applications
                Classpath Errors
                Class Loaders
                Common Java Errors
        Troubleshooting Servers
                Native Libraries
                Threading Architecture
                Work Managers
                Deadlocks
                Overload Protection
                Deployment Problems
        Troubleshooting JDBC
                Data Source Management
                Diagnostics
                Debug Flags
                Connectivity Problems
                Connection Leaks
                Database Availability
        Troubleshooting JMS
                Management
                MBean Hierarchy
                Message Logging
                Diagnostics
                Debug Flags
                Overload Protection
                Lost Messages
                Duplicate Messages
        Troubleshooting Security
                SSL Internals
                Keystore Management
                Debug Flags
                Common SSL Problems
                Certificate Validation
                Embedded LDAP
                Security Audit
                Common LDAP Problems
        Troubleshooting Node Manager
                Internals
                Security
                Common Issues
        Troubleshooting Clusters
                Plug-in Configuration
                OHS Overview
                Plug-in Connectivity
                Plug-in Diagnostics
                Unicast Communication
                Replication Debug Flags
                Typical Replication Issues
  曙海企业  
  备案号:沪ICP备08026168号 .(2014年7月11)...................
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