{"title":"eSource and Risk-Based Monitoring","authors":"N. Sharma","doi":"10.14524/CR-16-0001","DOIUrl":"https://doi.org/10.14524/CR-16-0001","url":null,"abstract":"The growing cost of drug development paves the way for newer technologies in clinical research. Taking its cue from success stories of automation across industries, the pharmaceutical sector’s acceptance of the Cloud, Big Data, and analytics stands as a testimony to changing times. Risk-based monitoring (RBM) looks at study issues at the root level and uses technology to challenge the status quo. The need for 100% source data verification (SDV) is being challenged, and innovative ideas to reduce SDV are being explored. Electronic source (eSource) can catalyze clinical trials transformation via RBM.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"178 1","pages":"26-29"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84883993","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}
P. Smailes, C. Reider, Rose Hallarn, L. Hafer, L. Wallace, W. Miser
{"title":"Implementation of a Research Participant Satisfaction Survey at an Academic Medical Center.","authors":"P. Smailes, C. Reider, Rose Hallarn, L. Hafer, L. Wallace, W. Miser","doi":"10.14524/CR-16-0003","DOIUrl":"https://doi.org/10.14524/CR-16-0003","url":null,"abstract":"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.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"37 1","pages":"42-47"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89781861","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}
{"title":"Revisiting the Future…Again!","authors":"D. Vulcano","doi":"10.14524/CR-16-4013","DOIUrl":"https://doi.org/10.14524/CR-16-4013","url":null,"abstract":"This edition of Clinical Researcher was assembled in celebration of the 40th anniversary of ACRP with the intent to look toward the future, rather than to provide a historical review. For the 30th anniversary of ACRP, the predecessor of this journal published some “Visions of the Future,” in which then-current and former ACRP leaders gazed into their crystal balls to report on where they thought ACRP would be at today’s 40th anniversary. I can’t tell you exactly what 10 years from now will look like because I (thankfully) am not determining that alone. I can, however, celebrate that it will be built with not only some of the greatest people I have (and will have) the privilege of knowing, but who also share the values of the ACRP mission and vision.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"1 1","pages":"4-5"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77209101","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}
{"title":"To Imagine the Future of Clinical Research","authors":"E. Weeks-Rowe","doi":"10.14524/CR-16-4016","DOIUrl":"https://doi.org/10.14524/CR-16-4016","url":null,"abstract":"There are endless possibilities for the future of clinical research, but the assurance of continued innovation requires reflection on our past experiences to map a pathway forward. In this article, a clinical research associate reflects on her nearly 15 years of experience in the field, and on where trends in technology and human interaction may take us in the years ahead.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"13 1","pages":"58-59"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86132642","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}
{"title":"Executive Director’s/Chair’s Message","authors":"J. Kremidas, B. Ibata","doi":"10.14524/CR-16-4007","DOIUrl":"https://doi.org/10.14524/CR-16-4007","url":null,"abstract":"You are one in a million. At ACRP, we’re honored to have been your voice and resource for the past 40 years. We think it’s time you gave yourself a loud round of applause to recognize the incredible contributions you’ve made, and will continue to make, to promote excellence in clinical research and advance new therapeutic options for humankind. It might sound like a big claim, but it’s mighty easy to back up.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"75 1","pages":"8-9"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86166512","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}
{"title":"Drug Products for Investigator- Initiated Research","authors":"Philip Burns","doi":"10.14524/CR-15-0040","DOIUrl":"https://doi.org/10.14524/CR-15-0040","url":null,"abstract":"Investigator-sponsored clinical research is different from company-sponsored research. Pursuing an idea for a drug requires having the physical drug available. The effort applied to making that drug can be as critical as the effort applied to the clinical research. The manufacturing, packaging, and testing of the drug product is discussed in this article, including details about the facility, equipment, and personnel requirements. The control efforts to minimize drug variation have implications for the researcher and the subjects involved. The controls are extensive, and are not intuitively obvious.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"57 1","pages":"18-21"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90853928","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}
{"title":"Bonnie Miller’s recipe for success begins with hard work, risk-taking, and a heaping scoop of good humor","authors":"J. Meseke","doi":"10.14524/CR-16-4010","DOIUrl":"https://doi.org/10.14524/CR-16-4010","url":null,"abstract":"Bonnie Miller’s recipe for success begins with hard work, risk-taking, and a heaping scoop of good humor. In this Q&A, Miller shares details from her professional background and where her expertise in clinical operations, good clinical practices, standard operating procedures, infrastructure, training, and mentoring have taken her in her career.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"34 1","pages":"78-79"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79718993","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}
{"title":"Ten Years Have Got Behind Me","authors":"G. Cramer","doi":"10.14524/CR-16-4017","DOIUrl":"https://doi.org/10.14524/CR-16-4017","url":null,"abstract":"In this article, the Managing Editor for Clinical Researcher looks back on how he began his career with ACRP just as the Association was celebrating its 30th anniversary, and considers the melancholy and excitement engendered by celebrating 10 years with ACRP even as the 40th anniversary arrives.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"54 1","pages":"68-69"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76958367","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}
Franeli M. Yadao, S. M. Rockwell, Laurie A. Halloran, James Michael Causey
{"title":"Clinical Researcher Roundtable","authors":"Franeli M. Yadao, S. M. Rockwell, Laurie A. Halloran, James Michael Causey","doi":"10.14524/CR-16-4014","DOIUrl":"https://doi.org/10.14524/CR-16-4014","url":null,"abstract":"In this feature, the Editor-in-Chief of Clinical Researcher leads a wide-ranging discussion with three experienced professionals from different corners of the clinical research enterprise, examining their greatest professional triumphs, what’s surprised them most in the last several years, and advice they’d give to someone considering joining the clinical research field.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"7 1","pages":"50-53"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83452179","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}
{"title":"A Look Back on the Development of Good Clinical Practice","authors":"M. Hamrell","doi":"10.14524/CR-16-4008","DOIUrl":"https://doi.org/10.14524/CR-16-4008","url":null,"abstract":"As we celebrate the 40th anniversary of ACRP, this installment of the “QA Q&A Corner” reflects back on the changes in tone and direction that have happened in the realm of good clinical practice—the international quality standard for the conduct of clinical trials—over the past 40 years and more.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"21 1","pages":"71-71"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73150480","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}
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