Honari Shari, Caceres Maria, Romo Mariana, Gibran Nicole S, Gamelli Richard L
From the *Department of Surgery, University of Washington Regional Burn Center, Harborview Medical Seattle; and †Department of Surgery, Loyola University Medical Center, Maywood, Illinois.
J Burn Care Res. 2016 Mar-Apr;37(2):127-34. doi: 10.1097/BCR.0000000000000264.
As health-care complexity and costs increase, evidence-based research has become essential to the advancement of burn care. Multicenter trials involve procedures, regulations, and guidelines that require meticulous attention to details and strict adherence to compliance issues. Taking on a large, multicenter trial can be a daunting task for a new burn research coordinator. The purpose of this article is to provide a resource for new burn research coordinators in multicenter clinical trial planning, especially in the field of burns. The burn research coordinator must possess organizational and multitasking skills, attention to detail, professionalism, initiative, and motivation. The burn research coordinator must exercise five principles of practice: compliance, confidentiality, consistency and correctness, and collaboration. Compliance assures subject safety, study integrity, and burn center reputation. Confidentiality is essential, especially when handling sensitive health information. Maintaining subject privacy through secure links and destruction of linked data in a timely matter protects the subjects and complies with the regulations of many governing bodies. Consistency and correctness minimize human errors through continuous data validation and self-auditing and peer auditing. Collaboration between the Principal Investigator/burn research coordinator and all departments involved in the study maintains the study focus and allows for enforcement of procedures. Preparing a budget confirms adequate compensation for work done by the research team and can be broken down into the following five steps: protocol review, calculation of initial payment, establishment of indirect costs, calculation of direct costs, and budget negotiation. Over time, one becomes familiar with the details involved with study success. Advocating for subject safety and protocol adherence are of highest priority. Study design is the most important element that dictates the success of the study. Anticipating the direct and indirect costs of a particular trial assures that the study can be completed with adequate allotment for staff time, laboratory costs, and supplies. Regular communication with the Principal Investigator, clinical staff, and consultants is vital for study completion. An essential contributor to burn research and the advancement of burn care, the burn research coordinator must balance many study-related tasks. Through the practice of compliance, confidentiality, and organization/planning, the burn research coordinator can ensure proper study management. These recommendations may assist new burn research coordinators in their practice.
随着医疗保健的复杂性和成本不断增加,循证研究对于烧伤护理的进步变得至关重要。多中心试验涉及程序、法规和指南,这需要对细节给予精心关注并严格遵守合规问题。对于一名新的烧伤研究协调员而言,开展一项大型多中心试验可能是一项艰巨的任务。本文的目的是为新的烧伤研究协调员提供一份在多中心临床试验规划方面的资源,尤其是在烧伤领域。烧伤研究协调员必须具备组织和多任务处理能力、注重细节、专业精神、主动性和积极性。烧伤研究协调员必须践行五项实践原则:合规、保密、一致性与正确性以及协作。合规可确保受试者安全、研究完整性以及烧伤中心的声誉。保密至关重要,尤其是在处理敏感健康信息时。通过安全链接维护受试者隐私并及时销毁关联数据可保护受试者并符合许多管理机构的规定。一致性与正确性通过持续的数据验证、自我审核和同行审核将人为错误降至最低。主要研究者/烧伤研究协调员与研究涉及的所有部门之间的协作可保持研究重点并便于程序的执行。编制预算可确认对研究团队所做工作给予足够的补偿,并且可细分为以下五个步骤:方案审查、初始付款计算、间接成本确定、直接成本计算以及预算谈判。随着时间推移,人们会熟悉研究成功所涉及的细节。倡导受试者安全和遵守方案是最优先事项。研究设计是决定研究成功的最重要因素。预估特定试验的直接和间接成本可确保研究能够在为工作人员时间、实验室成本和物资提供足够分配的情况下完成。与主要研究者、临床工作人员和顾问定期沟通对于研究完成至关重要。作为烧伤研究和烧伤护理进步的重要贡献者,烧伤研究协调员必须平衡许多与研究相关的任务。通过践行合规、保密以及组织/规划,烧伤研究协调员可确保对研究进行妥善管理。这些建议可能会帮助新的烧伤研究协调员开展工作。