发布求助
文献互助 智能选刊 最新文献

Clinical researcher (Alexandria, Va.)最新文献

筛选
英文 中文
Challenges to the Implementation of Risk-Based Monitoring 实施基于风险的监测的挑战
Clinical researcher (Alexandria, Va.) Pub Date : 2016-06-01 DOI: 10.14524/CR-15-0034
S. Patkar, J. Dalal
{"title":"Challenges to the Implementation of Risk-Based Monitoring","authors":"S. Patkar, J. Dalal","doi":"10.14524/CR-15-0034","DOIUrl":"https://doi.org/10.14524/CR-15-0034","url":null,"abstract":"Regulatory agencies, multinational companies, and contract research organizations across the globe advocate implementation of risk-based monitoring (RBM) due to its perceived benefits, yet the pharmaceutical industry has yet to employ it on a full scale. Implementing the RBM strategy confidently and consistently among all stakeholders requires a shift in mindset from conducting 100% source data verification to a risk-based approach, cognizance of evolving roles, consistent understanding of RBM’s underlying principles and methodology, objective decision-making, and more regulatory guidance.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"11 1","pages":"57-60"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88045012","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: 2
The Rise of Electronic Data Capture and its Greatest Obstacle 电子数据采集的兴起及其最大障碍
Clinical researcher (Alexandria, Va.) Pub Date : 2016-06-01 DOI: 10.14524/CR-16-0004
Colton E. Castle, A. Bell, P. Gwirtz
{"title":"The Rise of Electronic Data Capture and its Greatest Obstacle","authors":"Colton E. Castle, A. Bell, P. Gwirtz","doi":"10.14524/CR-16-0004","DOIUrl":"https://doi.org/10.14524/CR-16-0004","url":null,"abstract":"Advancement in healthcare-related technologies has resulted in a groundswell of information contained in patient health records. Electronic data abstraction systems have allowed medical professionals to analyze and apply vast bodies of information comprehensively. In the field of clinical trial management, electronic data capture (EDC) has become vital to this process. Over time, EDC yields benefits in cost, trial duration, and the capacity to utilize remote monitoring. However, EDC implementation can prove costly, and often causes temporary disruptions to workflow and productivity.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"27 1","pages":"30-33"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73699382","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
Clinical researcher (Alexandria, Va.) Pub Date : 2016-06-01 DOI: 10.14524/CR-16-4022
Kris Walters-Herring
{"title":"QA Q&A Corner","authors":"Kris Walters-Herring","doi":"10.14524/CR-16-4022","DOIUrl":"https://doi.org/10.14524/CR-16-4022","url":null,"abstract":"Several misconceptions prevail regarding what constitutes “quality” and a “quality program.” When designing a quality program, one must distinguish between quality, quality system, and compliance. These terms are used pervasively throughout the clinical research arena, and they are often erroneously used interchangeably.\u0000\u0000Editor’s Note: For this issue, the usual author of this column, Michael R. Hamrell, PhD, RAC, RQAP-GCP, CCRA, is pleased to present Dr. Walters-Herring, a professor and expert compliance consultant in clinical research, as an invited contributor to address the role and importance of quality programs in clinical research.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"76 1","pages":"55-56"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79966094","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
Site Monitoring an Expensive Affair 站点监控是一件昂贵的事情
Clinical researcher (Alexandria, Va.) Pub Date : 2016-06-01 DOI: 10.14524/CR-15-0037
Priya Temkar
{"title":"Site Monitoring an Expensive Affair","authors":"Priya Temkar","doi":"10.14524/CR-15-0037","DOIUrl":"https://doi.org/10.14524/CR-15-0037","url":null,"abstract":"The shift from classical study monitoring practices to adopting advanced practices is well under way in the pharmaceutical industry. Risk-based monitoring, remote central monitoring, and eSource are already popular and are being largely considered as effective solutions for improved quality, as well as for time and cost savings. This article offers insights on the potential benefits of changes in another aspect of a monitor’s responsibilities, in terms of non-onsite work or support work, which can be delegated/outsourced to monitoring support teams in order to save further on monitoring costs.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"144 1","pages":"50-54"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77514565","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
Maximize Your EHR Systems for Clinical Trials Operations 最大化您的EHR系统的临床试验操作
Clinical researcher (Alexandria, Va.) Pub Date : 2016-06-01 DOI: 10.14524/CR-15-0048
D. Vulcano, Candida Barlow, Natalie F. Scully, Cynthia M. Soto-Azghani, Anthony Keyes, S. Ziemba
{"title":"Maximize Your EHR Systems for Clinical Trials Operations","authors":"D. Vulcano, Candida Barlow, Natalie F. Scully, Cynthia M. Soto-Azghani, Anthony Keyes, S. Ziemba","doi":"10.14524/CR-15-0048","DOIUrl":"https://doi.org/10.14524/CR-15-0048","url":null,"abstract":"Many clinical trial sites are part of healthcare providers that either have converted, or are in the process of converting, to electronic health records. As these systems were neither designed nor purchased to support research operations, research staff have struggled with obtaining the internal resources to maximize the benefit of such conversions. This article assists research staff in building and implementing business cases for their institutions to expend resources for tying research operations support functionality into their electronic health records, supported by case histories and suggested resources.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"12 1","pages":"16-25"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78920858","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 执行董事的话
Clinical researcher (Alexandria, Va.) Pub Date : 2016-06-01 DOI: 10.14524/CR-16-4023
J. Kremidas
{"title":"Executive Director’s Message","authors":"J. Kremidas","doi":"10.14524/CR-16-4023","DOIUrl":"https://doi.org/10.14524/CR-16-4023","url":null,"abstract":"If you attended our successful ACRP 2016 Meeting & Expo in Atlanta, Ga. in April, you had the chance to see the unveiling of ACRP’s new logo and philosophy: For Learning. For Listening. For Life. While I believe we all shared the excitement of viewing and discussing ACRP’s new look, I also believe the actions we’ve begun to take to support it are what are most important.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"18 1","pages":"8-9"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78507069","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 Data-Tech连接
Clinical researcher (Alexandria, Va.) Pub Date : 2016-06-01 DOI: 10.14524/CR-16-4020
E. Muñiz
{"title":"Data-Tech Connect","authors":"E. Muñiz","doi":"10.14524/CR-16-4020","DOIUrl":"https://doi.org/10.14524/CR-16-4020","url":null,"abstract":"Today, drug development is carried out in human subjects and animals. However, as computing power and the number of sophisticated technology platforms grow exponentially, and our knowledge of human health and disease increases, the virtualization of clinical research and development will grow steadily.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"289 1","pages":"39-41"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78890207","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
Implementation of a Research Participant Satisfaction Survey at an Academic Medical Center. 某学术医疗中心研究参与者满意度调查之实施。
Clinical researcher (Alexandria, Va.) Pub Date : 2016-06-01
Paula Smailes, Carson Reider, Rose Kegler Hallarn, Lisa Hafer, Lorraine Wallace, William F Miser
{"title":"Implementation of a Research Participant Satisfaction Survey at an Academic Medical Center.","authors":"Paula Smailes,&nbsp;Carson Reider,&nbsp;Rose Kegler Hallarn,&nbsp;Lisa Hafer,&nbsp;Lorraine Wallace,&nbsp;William F Miser","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This descriptive case study covers the development of a survey to assess research subject satisfaction among those participating in clinical research studies at an academic medical center (AMC). The purpose was twofold: to gauge the effectiveness of the survey, as well as to determine the level of satisfaction of the research participants. The authors developed and implemented an electronic research participant satisfaction survey. It was created to provide research teams at the authors' AMC with a common instrument to capture research participant experiences in order to improve upon the quality of research operations. The instrument captured participant responses in a standardized format. Ultimately, the results are to serve as a means to improve the research experience of participants for single studies, studies conducted within a division or department of the AMC, or across the entire research enterprise at the institution. For ease of use, the survey was created within an electronic data capture system known as REDCap, which is used by a consortium of more than 1,800 institutional partners as a tool from the Clinical and Translational Science Awards (CTSA) program of the National Institutes of Health (NIH). Participants in the survey described in this article were more than 18 years of age and participating in an institutional review board (IRB)-approved study. Results showed that the vast majority of participants surveyed had a positive experience engaging in research at the authors' AMC. Further, the tool was found to be effective in making that determination. The authors hope to expand the use of the survey as a means to increase research satisfaction and quality at their university.</p>","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"30 3","pages":"42-47"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4933303/pdf/nihms792345.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34712217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Good Management Practice 良好管理守则
Clinical researcher (Alexandria, Va.) Pub Date : 2016-06-01 DOI: 10.14524/CR-16-4019
Martin Robinson
{"title":"Good Management Practice","authors":"Martin Robinson","doi":"10.14524/CR-16-4019","DOIUrl":"https://doi.org/10.14524/CR-16-4019","url":null,"abstract":"A common career change for many people working in clinical research is to move from “operations” into “project management.” For some, this transition may be reasonably gradual; for others, the move may be more sudden. Making this transition can sometimes seem overwhelming; however, one of the key roles of a manager is to help his or her staff make the transition smoothly.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"21 1","pages":"48-49"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75670173","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: 1
Careers—Passing It On 职业生涯——传承下去
Clinical researcher (Alexandria, Va.) Pub Date : 2016-06-01 DOI: 10.14524/CR-16-4025
J. Meseke
{"title":"Careers—Passing It On","authors":"J. Meseke","doi":"10.14524/CR-16-4025","DOIUrl":"https://doi.org/10.14524/CR-16-4025","url":null,"abstract":"Dan Dumrauf, director at Medix Scientific, understands the unique challenges of identifying leading resource talent for the clinical research industry, and is not afraid to confront obstacles head on. Hiring the right talent is one of the toughest things to do, he says, especially when the organization’s leaders or the talented prospects don’t know exactly what they are looking for.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"34 1","pages":"63-64"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89489354","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
首页 上一页 下一页 尾页
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整，为了账户安全，请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们：info@booksci.cn Book学术提供免费学术资源搜索服务，方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号：481959085
Book学术官方微信