Primer: establishing a clinical trial unit - regulations and infrastructure.

Fleischmann R

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Primer: establishing a clinical trial unit - regulations and infrastructure.

机译：底漆：建立临床试验部门-法规和基础设施。

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The performance of clinical trials can be very rewarding for the practicing or academic clinical rheumatologist. There are at least 50 new compounds - small molecules and biologics - in development for rheumatic diseases such as rheumatoid arthritis, osteoarthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, scleroderma, gout and fibromyalgia. Clinical trials are important to try to determine the appropriate use of these compounds, as well as to answer questions about their safety. To carry out clinical trials effectively, the physician-investigator must be aware of, and adhere to, the regulatory requirements. The purpose of this article is to review these requirements in depth, as well as to discuss the infrastructure required to establish a successful clinical trial unit.

机译：对于临床或风湿病临床医师来说，临床试验的执行可能会非常有益。针对风湿性疾病，例如类风湿性关节炎，骨关节炎，系统性红斑狼疮，强直性脊柱炎，银屑病关节炎，硬皮病，痛风和纤维肌痛，至少有50种新化合物（小分子和生物制剂）正在开发中。临床试验对于尝试确定这些化合物的适当用途以及回答有关其安全性的问题非常重要。为了有效地进行临床试验，医师研究人员必须了解并遵守法规要求。本文的目的是深入研究这些要求，并讨论建立成功的临床试验单位所需的基础结构。

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《Nature clinical practice. Rheumatology》 |2007年第4期|共6页
作者
Fleischmann R;
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正文语种 eng
中图分类免疫性疾病;
关键词
Antirheumatic Agents; Clinical Trials; Rheumatic Diseases; 抗风湿药; 临床试验; 风湿性疾病;

机译：Antirheumatic Agents;Clinical Trials;Rheumatic Diseases;抗风湿药;临床试验;风湿性疾病;

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1. Primer: establishing a clinical trial unit - regulations and infrastructure. [J] . Fleischmann R Nature clinical practice. Rheumatology . 2007,第4期

机译：底漆：建立临床试验部门-法规和基础设施。
2. Trial Steering Committees in randomised controlled trials: A survey of registered clinical trials units to establish current practice and experiences [J] . Conroy Elizabeth J., Harman Nicola L., Lane J. Athene, Clinical trials: journal of the Society for Clinical Trials . 2015,第6期

机译：随机对照试验中的试验指导委员会：对注册临床试验单位的调查，以建立当前的实践和经验
3. A community-academic partnership to explore informational needs of African American women as a primer for cancer clinical trial recruitment [J] . Rivers Desiree A., Pal Tuya, Vadaparampil Susan T., Ethnicity & health . 2019,第6期

机译：社区学术伙伴关系，探讨非洲裔美国女性的信息需求作为癌症临床试验招聘的底漆
4. Establishing an Interoperable Clinical Trial Information System Within MIRACUM [C] . Hanna HASSELBLATT, Johanna ANDRAE, Adrian TASSONI, EFMI STC 2019 . 2019

机译：在Miracum中建立可互操作的临床试验信息系统
5. Establishing an outsourcing program needed for the packaging and labeling of pharmaceutical products used during clinical trials for XYZ Corporation. [D] . Dubourg, Gladys. 2003

机译：为XYZ Corporation建立在临床试验中使用的药品包装和标签所需的外包计划。
6. Role of clinical trials informatics in the NCIs cancer informatics infrastructure. [O] . J. Silva, R. Wittes 1999

机译：临床试验信息学在NCI的癌症信息学基础架构中的作用。
7. Proposal for a Council Regulation (EEC) fixing indicative ceilings and establishing Community supervision of imports of certain products originating in Austria (1977); Proposal for a Council Regulation (EEC) fixing indicative ceilings and establishing Community supervision of imports of certain products originating in Finland (1977); Proposal for a Council Regulation (EEC) establishing Community supervision of imports of certain products originating in Iceland (1977); Proposal for a Council Regulation (EEC) fixing indicative ceilings and establishing Community supervision of imports of certain products originating in Norway (1977); Proposal for a Council Regulation (EEC) fixing indicative ceilings and establishing Community supervision of imports of certain products originating in Portugal (1977); Proposal for a Council Regulation (EEC) fixing indicative ceilings and establishing Community supervision of imports of certain products originating in Sweden(1977); Proposal for a Council Regulation (EEC) establishing Community supervision of imports of certain products originating in Switzerland (1977); Draft of decision of the representatives of the governments of the Member States of the European Coal and Steel Community, meeting within the Council establishing supervision of imports of certain products originating in Austria (1977); Draft of decision of the representatives of the governments of the Member States of the European Coal and Steel Community, meeting within the Council establishing supervision of imports of certain products originating in Sweden (1977) (submitted to the Council by the Commission). COM (76) 489 final, 24 September 1976 [O] . 1976

机译：关于理事会条例（EEC）的提案，确定指示性上限并建立共同体对源自奥地利的某些产品进口的监督（1977年）;关于理事会条例（EEC）的提案，确定指示性上限并建立共同体对源自芬兰的某些产品进口的监督（1977年）;建议理事会条例（EEC）建立共同体对源自冰岛的某些产品进口的监督（1977年）;关于理事会条例（EEC）的提案，确定指示性上限并建立共同体对源自挪威的某些产品进口的监督（1977年）;关于理事会条例（EEC）的提案，确定指示性上限并建立共同体对源自葡萄牙的某些产品进口的监督（1977年）;关于理事会条例（EEC）的提案，确定指示性上限并建立共同体对源自瑞典的某些产品进口的监督（1977年）;建议理事会条例（EEC）建立共同体对源自瑞士的某些产品进口的监督（1977年）;欧洲煤钢共同体成员国政府代表的决定草案，在理事会内举行会议，对源自奥地利的某些产品的进口实施监督（1977年）;欧洲煤钢共同体成员国政府代表的决定草案，在理事会内举行会议，对源自瑞典的某些产品的进口实施监督（1977年）（由委员会提交理事会）。 COm（76）489决赛，1976年9月24日
8. Community Clinical Oncology Program and Minority-Based Community Clinical Oncology Program: Accomplishments in Cancer Clinical Trials [R] . 2011

机译：社区临床肿瘤学计划和基于少数民族的社区临床肿瘤学计划：癌症临床试验的成就

Primer: establishing a clinical trial unit - regulations and infrastructure.

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