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Patient organisations: COVID-19 concerns related to human research 患者组织:与人体研究相关的COVID-19问题
Regulatory Affairs Watch Pub Date : 2021-03-01 DOI: 10.54920/scto.2021.rawatch.5.20
{"title":"Patient organisations: COVID-19 concerns related to human research","authors":"","doi":"10.54920/scto.2021.rawatch.5.20","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.5.20","url":null,"abstract":"Patient organisations support and advocate for the patient communities they represent while also increasing the role of patients in improving and shaping healthcare practices, policies, and systems. During the coronavirus pandemic, patient organisations have provided their patient communities with relevant information on COVID-19 and have brought patients’ perspectives into the dialogue around COVID-19. Moreover, they have advocated for patients’ needs and concerns related to the pandemic’s effects on human research and to coronavirus vaccine development and authorisation. This article summarises several of the issues facing patient communities during the pandemic and provides examples of patient organisations’ responses to these issues.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"46 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125562980","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
Supporting research during the pandemic: How the Swiss National Science Foundation has responded to COVID-19 大流行期间支持研究:瑞士国家科学基金会如何应对COVID-19
Regulatory Affairs Watch Pub Date : 2021-03-01 DOI: 10.54920/scto.2021.rawatch.5.13
Irène Knüsel, Stéphanie Wyss, Pascal Walther, Marc Zbinden
{"title":"Supporting research during the pandemic: How the Swiss National Science Foundation has responded to COVID-19","authors":"Irène Knüsel, Stéphanie Wyss, Pascal Walther, Marc Zbinden","doi":"10.54920/scto.2021.rawatch.5.13","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.5.13","url":null,"abstract":"As the foremost research funding organisation in Switzerland, the Swiss National Science Foundation (SNSF) plays a key role in promoting scientific research in Switzerland. In 2019, the SNSF supported 18,900 researchers with over 1 billion Swiss francs in order to promote research that benefits society, the economy, and politics. All three of these areas have been dramatically affected by the COVID-19 pandemic – with profound national and inter- national consequences. This article provides an overview of the SNSF’s national and international responses to the pandemic, discusses the challenges the SNSF has faced during the pandemic, and highlights lessons learnt so far.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"68 31","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"120887083","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
COVID: 1–9 work practices and lessons learnt at one CTU COVID:在一个CTU的1-9个工作实践和经验教训
Regulatory Affairs Watch Pub Date : 2021-03-01 DOI: 10.54920/scto.2021.rawatch.5.10
Madeleine Vollmer, Claudia Becherer
{"title":"COVID: 1–9 work practices and lessons learnt at one CTU","authors":"Madeleine Vollmer, Claudia Becherer","doi":"10.54920/scto.2021.rawatch.5.10","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.5.10","url":null,"abstract":"The pandemic hit us all much faster and to a larger extent than we could have imagined. We have had to find strategies for adapting quickly to the circumstances on both private and business levels. The Department of Clinical Research (DKF) at the University Hospital Basel (USB) has developed work practices for how to reconcile home office and work, how to handle frequently updated guidelines, and how to respond to questions from researchers about their clinical trials. In this article, we summarise nine DKF work practices and discuss lessons learnt during the corona crisis.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"244 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134274667","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
The role of swissethics and ethics committees during the COVID-19 pandemic 2019冠状病毒病大流行期间瑞士伦理委员会的作用
Regulatory Affairs Watch Pub Date : 2021-03-01 DOI: 10.54920/scto.2021.rawatch.5.17
{"title":"The role of swissethics and ethics committees during the COVID-19 pandemic","authors":"","doi":"10.54920/scto.2021.rawatch.5.17","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.5.17","url":null,"abstract":"","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"37 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125149126","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
A national survey on the use of EHR systems in clinical research 在临床研究中使用电子病历系统的全国调查
Regulatory Affairs Watch Pub Date : 2020-10-01 DOI: 10.54920/scto.2021.rawatch.4.23
Elke Hiendlmeyer
{"title":"A national survey on the use of EHR systems in clinical research","authors":"Elke Hiendlmeyer","doi":"10.54920/scto.2021.rawatch.4.23","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.4.23","url":null,"abstract":"Every day, more and more health data are captured and documented electronically instead of in stacks of printouts, as it often once was. The near future promises a full transition from paper to electronic records. This digital progress is felt far beyond the initial steps of capturing patient records, however. Health data are a fundamental building block of clinical trials. So the practices of how data are selected and collected are closely linked to the regulatory requirements of clinical trials and how these trials will be run from an operational standpoint.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"29 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"117081675","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
Towards a national strategy for registries and cohorts 制定国家登记和队列战略
Regulatory Affairs Watch Pub Date : 2020-10-01 DOI: 10.54920/scto.2021.rawatch.4.12
A. Nienhaus
{"title":"Towards a national strategy for registries and cohorts","authors":"A. Nienhaus","doi":"10.54920/scto.2021.rawatch.4.12","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.4.12","url":null,"abstract":"","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130976096","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
Medical registries: An illustration of how governance works at the university hospital level 医疗登记:大学医院级别的治理如何运作的说明
Regulatory Affairs Watch Pub Date : 2020-10-01 DOI: 10.54920/scto.2021.rawatch.4.20
{"title":"Medical registries: An illustration of how governance works at the university hospital level","authors":"","doi":"10.54920/scto.2021.rawatch.4.20","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.4.20","url":null,"abstract":"Interview with Julia Parafita, project leader for data registries, medical direction, CHUV","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133288656","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
Swiss Multiple Sclerosis Registry: A landmark project for citizen science 瑞士多发性硬化症登记处:公民科学的里程碑项目
Regulatory Affairs Watch Pub Date : 2020-10-01 DOI: 10.54920/scto.2021.rawatch.4.17
Philipp do Canto
{"title":"Swiss Multiple Sclerosis Registry: A landmark project for citizen science","authors":"Philipp do Canto","doi":"10.54920/scto.2021.rawatch.4.17","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.4.17","url":null,"abstract":"Since its foundation in 1959, the Swiss Multiple Sclerosis Society (Swiss MS Society) has been supporting people living with multiple sclerosis (MS) in their daily lives. The organisation also provides funding for scientific research and serves as an independent platform for information related to MS. The quest to better understand MS and ultimately find its cure has always been a driver for innovation. Seizing the opportunities created by the emergence of data-driven medicine, the Swiss MS Society created the Swiss MS Registry – the first health registry in Switzerland owned exclusively by a patient organisation.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"30 6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124326035","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
Medical registries and their use for research projects 医疗登记及其在研究项目中的使用
Regulatory Affairs Watch Pub Date : 2020-10-01 DOI: 10.54920/scto.2021.rawatch.4.4
Elke Hiendlmeyer, F. Jörger
{"title":"Medical registries and their use for research projects","authors":"Elke Hiendlmeyer, F. Jörger","doi":"10.54920/scto.2021.rawatch.4.4","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.4.4","url":null,"abstract":"Registries provide important real-world data about public health and thus have a major impact on far-reaching political health decisions and medical patient care. In addition, registries contribute to transparency and comparability of medical services and are the basis for epidemiological and clinical research. Last but not least, they play a key role for quality assurance and the development of medical services (Mathis-Edenhofer and Piso 2011). It is therefore hardly surprising that the number of registries in Switzerland is steadily increasing. In order to effectively operate registries and use them for research purposes, it is essential to ensure the quality of the collected data and their compliance with regulatory requirements. This article provides an overview of medical registries by discussing four related questions.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"61 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114645629","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
Using medical registries: Switzerland’s implant registry SIRIS as a successful model 使用医疗登记:瑞士的植入物登记SIRIS是一个成功的模式
Regulatory Affairs Watch Pub Date : 2020-10-01 DOI: 10.54920/scto.2021.rawatch.4.14
Nicole Steck, M. Zwahlen, A. Spoerri
{"title":"Using medical registries: Switzerland’s implant registry SIRIS as a successful model","authors":"Nicole Steck, M. Zwahlen, A. Spoerri","doi":"10.54920/scto.2021.rawatch.4.14","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.4.14","url":null,"abstract":"With the increasing use of implantable medical devices, registries are critical for conducting post-market surveillance and identifying long-term safety risks. Switzerland’s national implant registry SIRIS is an outstanding example of the benefits a well-managed registry can provide to different players in healthcare. The SIRIS registry also illustrates how to ensure high-quality registry data.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131530262","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
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