Irving Institute for Clinical and Translational Science, Columbia University Irving Medical Center, New York, New York, USA.
Clin Transl Sci. 2023 Jun;16(6):915-921. doi: 10.1111/cts.13516. Epub 2023 May 4.
Clinical Research Coordinators (CRCs) are vital collaborators in a clinical research project. They often are the primary liaisons between investigators and human participants in studies and are involved in every aspect of many protocols, including participant recruitment, care (both usual medical care and specific study-related monitoring and procedures), data collection, specimen processing, and follow-up. The Clinical Translational Science Award program, which was created by the National Institutes of Health in 2006, has significantly expanded the venues in which Clinical Research Resource (CRR) - based CRCs are embedded. CRCs functioning in these areas, outside of the research-focused in-patient environment of the CRR, are designated as "off-site" CRCs. Many of these locations, such as intensive care units and emergency departments, require that CRCs interact regularly with healthcare providers whose primary functions are focused on providing optimal patient care rather than research and often involving very complex patients. These off-site CRCs require additional training and support outside of the usual research-oriented environment of the CRR. They are required to function within the context of the patient-care team while fostering implementation of collaborative research. This is a description of such a program specifically geared to off-site CRCs with the goal of enhancing the quality of research and experiences of CRCs.
临床研究协调员(CRC)是临床研究项目中不可或缺的合作者。他们通常是研究中研究者和人类参与者之间的主要联络人,并且参与许多方案的各个方面,包括参与者招募、护理(包括常规医疗护理和特定的研究相关监测和程序)、数据收集、标本处理和随访。临床转化科学奖计划于 2006 年由美国国立卫生研究院创建,大大扩大了临床研究资源(CRR)为基础的 CRC 所在的场所。在 CRR 专注于研究的住院环境之外的这些领域中运作的 CRC 被指定为“场外”CRC。这些地点中的许多,如重症监护病房和急诊部门,要求 CRC 定期与医疗保健提供者互动,这些提供者的主要职能集中在提供最佳的患者护理上,而不是研究,并且通常涉及非常复杂的患者。这些场外 CRC 需要在 CRR 的常规面向研究的环境之外接受额外的培训和支持。他们需要在患者护理团队的背景下运作,同时促进协作研究的实施。这是一个专门针对场外 CRC 的计划的描述,旨在提高研究质量和 CRC 的经验。