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Paving the Way for Workforce Innovation 为劳动力创新铺平道路
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-16-4050
James Michael Causey
{"title":"Paving the Way for Workforce Innovation","authors":"James Michael Causey","doi":"10.14524/CR-16-4050","DOIUrl":"https://doi.org/10.14524/CR-16-4050","url":null,"abstract":"ACRP’s Editor-in-Chief presents some of the insights gained from a recent discussion with the Association’s new Workforce Innovation Officer, Terri Hinkley, RN, BScN, MBA, CCRC, FACRP, about how rapid change across the clinical research enterprise requires a new set of skills and competencies from its professionals.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"136 1","pages":"8-9"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78541957","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quality Assurance from the Independent Site Perspective 从独立站点的角度看质量保证
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-16-4048
Christine Senn
{"title":"Quality Assurance from the Independent Site Perspective","authors":"Christine Senn","doi":"10.14524/CR-16-4048","DOIUrl":"https://doi.org/10.14524/CR-16-4048","url":null,"abstract":"So often, it seems that the forces of enrollment and quality assurance (QA) are at odds in clinical research. If a site focuses on enrollment, quality may suffer. If a site focuses on quality to the detriment of enrollment, the site may not survive the financial consequences. This column’s author considers the advantages of using both real-time and after-the-fact QA procedures at her organization.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"42 1","pages":"26-27"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77566290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Data-Tech Connect: Improving Technology Training to Facilitate Competency for the Clinical Research Professional 数据-技术连接:改进技术培训以促进临床研究专业人员的能力
Clinical researcher (Alexandria, Va.) Pub Date : 2016-10-01 DOI: 10.14524/CR-16-4035
P. Smailes
{"title":"Data-Tech Connect: Improving Technology Training to Facilitate Competency for the Clinical Research Professional","authors":"P. Smailes","doi":"10.14524/CR-16-4035","DOIUrl":"https://doi.org/10.14524/CR-16-4035","url":null,"abstract":"It is without question that the technological advances that have infiltrated the clinical research industry have created efficient workflows that allow for faster reporting of data with huge cost savings. However, systems powered by technology can often be complicated to use and may require extensive training.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"37 1","pages":"44-45"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75388778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Talent Management Tools and Tactics for Today’s Researchers 当今研究人员的人才管理工具和策略
Clinical researcher (Alexandria, Va.) Pub Date : 2016-10-01 DOI: 10.14524/CR-16-4043
James Michael Causey
{"title":"Talent Management Tools and Tactics for Today’s Researchers","authors":"James Michael Causey","doi":"10.14524/CR-16-4043","DOIUrl":"https://doi.org/10.14524/CR-16-4043","url":null,"abstract":"Clinical Researcher ’s editor-in-chief interviews some of the clinical research enterprise’s top thought leaders about the challenges of human talent management for leaders at study sites, sponsors, and contract research organizations, and for others in managerial roles in the clinical trial lifecycle.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"61 37","pages":"12-13"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72445394","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Increase Awareness of Research in Your Organization by Using the Marketing Megaphone 通过使用营销扩音器来提高组织对研究的认识
Clinical researcher (Alexandria, Va.) Pub Date : 2016-10-01 DOI: 10.14524/CR-15-0046
Shirley Trainor-Thomas, M. Materne
{"title":"Increase Awareness of Research in Your Organization by Using the Marketing Megaphone","authors":"Shirley Trainor-Thomas, M. Materne","doi":"10.14524/CR-15-0046","DOIUrl":"https://doi.org/10.14524/CR-15-0046","url":null,"abstract":"Marketing is crucial to the success of any clinical research program, and while many organizations excel at marketing study opportunities to the community, there is often a disconnect when it comes to an organization’s internal awareness of research. Many organizations conducting clinical research already have tools in place to facilitate successful study operations, but if physicians are unaware of these resources, they may shy away from research.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"4 1","pages":"52-53"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86027902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Executive Director’s Message: Learning, Listening, and Learning to Listen 执行董事寄语:学习，倾听，学会倾听
Clinical researcher (Alexandria, Va.) Pub Date : 2016-10-01 DOI: 10.14524/CR-16-4036
J. Kremidas
{"title":"Executive Director’s Message: Learning, Listening, and Learning to Listen","authors":"J. Kremidas","doi":"10.14524/CR-16-4036","DOIUrl":"https://doi.org/10.14524/CR-16-4036","url":null,"abstract":"ACRP’s Executive Director has had the opportunity to do a lot of listening and learning in the past several months as he visited with ACRP chapters in Salt Lake City and Chicago. More meetings with chapter members around the country are on the schedule. He writes that it’s been an invaluable educational experience, and reflects on what he’s learned so far in his first year with the Association.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"10 1","pages":"6-7"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88148724","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Research Compliance: Launch of Medicare’s Oncology Care Model—An Opportunity for Administrative Reform 研究合规:医疗保险肿瘤护理模式的启动-行政改革的机会
Clinical researcher (Alexandria, Va.) Pub Date : 2016-10-01 DOI: 10.14524/CR-16-4039
L. Christianson
{"title":"Research Compliance: Launch of Medicare’s Oncology Care Model—An Opportunity for Administrative Reform","authors":"L. Christianson","doi":"10.14524/CR-16-4039","DOIUrl":"https://doi.org/10.14524/CR-16-4039","url":null,"abstract":"An examination of how Medicare recently began enrolling select oncology patients under its newest payment plan, the Oncology Care Model, many aspects of which have yet to be established.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"53 1","pages":"46-47"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86698912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
QA Q&A Corner: Regulations, Records, and Razzle-Dazzle in Research QA问答角:研究中的法规、记录和眼花缭乱
Clinical researcher (Alexandria, Va.) Pub Date : 2016-10-01 DOI: 10.14524/CR-16-4041
M. Hamrell
{"title":"QA Q&A Corner: Regulations, Records, and Razzle-Dazzle in Research","authors":"M. Hamrell","doi":"10.14524/CR-16-4041","DOIUrl":"https://doi.org/10.14524/CR-16-4041","url":null,"abstract":"This issue’s column considers some of the complicating factors regarding responsibilities, documentation, branding, and screening in clinical studies.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"1 1","pages":"50-51"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89552737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Addressing Educational Gaps in Biomarker and Pharmacogenomics Research Knowledge Among IRB/IEC Members 解决生物标志物和药物基因组学研究知识在IRB/IEC成员中的教育差距
Clinical researcher (Alexandria, Va.) Pub Date : 2016-10-01 DOI: 10.14524/CR-15-0038
D. Pulford, Linda M. Coleman, Kathleen M. Smith, Jennifer Ribeiro, S. Prucka
{"title":"Addressing Educational Gaps in Biomarker and Pharmacogenomics Research Knowledge Among IRB/IEC Members","authors":"D. Pulford, Linda M. Coleman, Kathleen M. Smith, Jennifer Ribeiro, S. Prucka","doi":"10.14524/CR-15-0038","DOIUrl":"https://doi.org/10.14524/CR-15-0038","url":null,"abstract":"What is the difference between biomarker and pharmacogenomic (PGx) research? How is this research conducted and what value does it have for patient care? These are just some of the questions that institutional review board and independent ethics committee (IRB/IEC) members may ask themselves when encountering PGx or biomarker research in a clinical protocol. This article summarizes findings from an Industry Pharmacogenomics Working Group survey of IRB/IEC members on related topics.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"19 1","pages":"28-33"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83323033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Monitoring of Clinical Trials—Are Remote Activities Helpful in Controlling Quality? 临床试验的监测——远程活动有助于控制质量吗?
Clinical researcher (Alexandria, Va.) Pub Date : 2016-10-01 DOI: 10.14524/CR-15-0049
M. Hamrell, Kathleen Mostek, Lyn Goldsmith
{"title":"Monitoring of Clinical Trials—Are Remote Activities Helpful in Controlling Quality?","authors":"M. Hamrell, Kathleen Mostek, Lyn Goldsmith","doi":"10.14524/CR-15-0049","DOIUrl":"https://doi.org/10.14524/CR-15-0049","url":null,"abstract":"The implementation of risk-based monitoring has spawned many forms of remote monitoring activities. This development has the potential to significantly impact how monitoring is accomplished for clinical trials. One question raised is whether remote monitoring activities are helpful or a hindrance to an effective data quality program. A survey was undertaken to assess the utilization and considerations related to remote monitoring activities and its impact on clinical data quality.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"7 1","pages":"18-21"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88682235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
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