Price Kandie C, Barrett Barbara K, Roark Jean M
Delaware Community Clinical Oncology Program, Christiana Care Health Services, Inc., Newark, Delaware, USA.
Clin Cancer Res. 2006 Jun 1;12(11 Pt 2):3642s-4s. doi: 10.1158/1078-0432.CCR-06-9014.
The Cancer and Leukemia Group B is dedicated to developing and implementing training programs that will enhance the skills and abilities of Clinical Research Associates (CRA) involved in all aspects of data collection and research. Training programs not only improve overall knowledge and professionalism but also improve the integrity of study data. The CRA roles and responsibilities include the following: collect, analyze, and monitor data; collaborate with other members of the health care team; insure regulatory mandates are followed; manage the care of research participants; assist in the recruitment and enrollment of human subjects; protect subjects rights by adhering to Institutional Review Board guidelines, the Code of Federal Regulations; prepare and submit timely adverse event experience reports; maintain case report forms and drug accountability records; educate other health care professionals, patients, and families regarding clinical trials; participate in research audits; and function as a team member with the research team. In addition, CRAs may also be responsible for writing reports, grant, and budget development and the development of protocols, forms, and informed consent documents.
癌症与白血病B组致力于开发和实施培训项目，以提升参与数据收集和研究各个方面的临床研究协调员（CRA）的技能和能力。培训项目不仅能提高整体知识水平和专业素养，还能提升研究数据的完整性。CRA的角色和职责包括以下方面：收集、分析和监测数据；与医疗团队的其他成员协作；确保遵循监管要求；管理研究参与者的护理；协助招募和纳入人类受试者；通过遵守机构审查委员会指南、联邦法规法典来保护受试者权利；及时准备和提交不良事件经验报告；维护病例报告表和药物 accountability 记录；就临床试验对其他医疗专业人员、患者及家属进行教育；参与研究审计；并作为研究团队的一员发挥作用。此外，CRA还可能负责撰写报告、申请资助和预算编制以及制定方案、表格和知情同意文件。
