Clinical Research Blog

QA & QC in clinical trials


Difference between QA and QC

Quality Assurance: 
Quality Assurance is the systematic and independent examination of all trial related activities and documents. Quality assurance determine whether the evaluated activities were appropriately conducted and data were generated, recorded, analyzed and accurately reported according to protocol, standard operating procedures and Good Clinical Practice.

Quality Control:
Periodic operational checks within each functional department to verify that the clinical data are generated, collected, handled, analyzed and reported according to protocol, standard operating procedures and Good Clinical Practice.

ACRP and IISRA Establish Strategic Partnership


Alexandria, Va.—The Association of Clinical Research Professionals (ACRP) and the Investigator Initiated Sponsored Research Association (IISRA) are pleased to announce the initiation of a strategic partnership. The two organizations share a commitment to supporting their membership through the creation of professional development activities, knowledge standards and exchange amongst members. Together, ACRP and IISRA aim to increase the level of service provided to their members by sharing resources through this collaborative partnership.

For members of IISRA this partnership will provide access to ACRP and IISRA knowledge resources through a specialty Interest Group on the ACRP website (scheduled for launch in May 2013), created for and supported by the IISRA leadership team. Upon joining ACRP, IISRA members will have full access to the resources available to ACRP members such as The Monitor, ACRP’s award-winning peer reviewed journal, and the ACRP Online Community, where a specialized eForum and resource library will be established for members of the IISRA organization.

IISRA’s President, Anton Ehrhardt, PhD says ‘The concentrated IISR expertise of IISRA and the deep clinical research expertise of the ACRP seem to form a synergistic match. Merging the two organizations will provide IISRA members with greater resources while allowing the IISRA leadership team the avenues to expand our impact within the clinical research environment.’

For ACRP, the partnership addresses a need of the ACRP membership by providing an immediate increase in resources and volunteer expertise in the field of investigator initiated-sponsored research (IISR). While the two organizations have worked collaboratively over time, most recently through IISRA leadership presenting a session at the ACRP Global Conference in Orlando in April, and at the Minnesota Chapter of ACRP in May, the partnership marks an official merger of the two organizations.

‘I am thrilled to have the opportunity to collaborate with the outstanding professionals of IISRA who have made such a superb contribution to clinical research.’ says ACRP Executive Director, Jim Thomasell. ‘The additional expertise in the area of investigator initiated-sponsored research will be invaluable to many current and future ACRP members and further enhances our ability to advance our mission.’

**ACRP**

Based in Alexandria, Va., and founded in 1976, the nonprofit ACRP has a worldwide membership of nearly 18,000 research professionals dedicated to the safe and ethical conduct of clinical trials across the globe for new drugs, medical devices, and therapies in volunteer human subjects.

**IISRA**

Founded in 2006, IISRA is an independent association of professionals dedicated to promoting excellence in investigator initiated-sponsored research (IISR) programs. IISRA is committed to supporting its membership through the development and implementation of educational activities, professional knowledge standards, and ethical practices.

新闻发布(中文翻译)
弗吉尼亚州亚历山德里亚市: “临床研究专业人员协会”(ACRP)同“研究者发起的受赞助的研究协会”(IISRA)很高兴地宣布了开始战略合作伙伴关系。这两个组织共同承诺,通过建立专业发展活动、知识标准、及成员之间的交换,支持他们的会员。通过这种合作伙伴关系,通过资源共享,ACRP和IISRA的目的是增加为其成员提供的服务水平。

对IISRA成员,这个伙伴关系,将通过ACRP网站上的一个专业兴趣组(定于2013年5月推出),提供ACR和IISRA的知识资源。该专业兴趣组由IISRA领导团队创建和支持。加入ACRP后,IISRA成员,如同ACEP成员一样,将得到享受ACRP的资源,例如《Monitor》,的完全权限,《Monitor》是ACRP的屡获殊荣的同行评审的杂志,并是在ACRP在线社区,其中有一个专门的网上论坛和将为IISRA成员建立的资源库。

IISRA公司的总裁、安东.俄哈特(Anoto Ehrhardt EH​​RHARDT)博士说:“IISRA的集中IISR专业知识和ACRP的丰富的临床研究专长,似乎形成一个强化的匹配。这两个组织的合作将为IISRA成员提供更多的资源,同时赋予IISRA领导团队更宽途径,扩大我们在临床研究环境的影响。”

对于ACRP,这个伙伴关系,通过立即增加资源,及在研究者发起的受赞助的研究(IISR)领域增加专业自愿支持,解决需求。这两个组织已经进行合作,最近例子包括4月在奥兰多举行的ACRP全球会议上,IISRA的领导提供一个专题项目; 再如在ACRP明尼苏达州分组的五月会议上,这两个组织的合作伙伴关系标志着正式合并。

ACRP执行长、吉姆.托马瑟尔(Jim Thomasell)说:“我很高兴能有机会与IISRA的优秀专业人才合作,他们对临床研究作出了如此高超的贡献。更多来自研究者发起的受赞助的研究领域的专业知识,对许多现有和未来的ACRP成员将是非常宝贵的,将进一步推动我们的使命。”

* ACRP **

总部设在弗吉尼亚州亚历山德里亚市,成立于1976年,该非营利性组织在世界各地有近18,000名专业研究人员组成的会员。在全球范围内临床新药品,新医疗器械及人类志愿者受试者中,该组织致力于安全和道德行为。

* IISRA **

IISRA成立于2006年,是一个独立的专业协会,致力于促进卓越的研究者发起主办的研究(IISR)计划。 IISRA致力于通过制定和实施教育活动,支持其成员的专业知识水平和伦理实践。

How to Use SAS – Lesson 2 – Creating Datasets on the Fly


 

临床研究中保护人类受试者 – 历史与美国现状


全文:临床研究中保护人类受试者 – 历史与美国现状

摘要:

该文介绍了美国临床研究中,保护人类受试者的历史与现状,以及与伦理学相关的法规、文件.希望对国内同行在医学和行为学研究中有关复杂的伦理及规则问题有借鉴作用.
作者: 林义顺
Author: LIN Yishun
作者单位: Temple Uniuersity Hospital,Philadelphia, PA 19140, U.S.A
期 刊: 福建医科大学学报(社会科学版)
Journal: JOURNAL OF FUJIAN MEDICAL UNIVERSITY(SOCIAL SCIENCE EDITION)
年,卷(期): 2005, 6(1)
分类号: R-055
关键词: 临床研究 知识脉络    人类受试者 知识脉络    历史 知识脉络    美国 知识脉络
机标分类号: R28 G64
在线出版日期: 2005年6月9日

 

 

美国癌症临床研究简介


美国癌症临床研究简介

放射肿瘤学 (第二章),第二版,(朱广迎主编)科学技术文献出版社,2007, ISBN9787502336707