Sanford Research, Sioux Falls, SD.
Kulkarni Law Firm, PC, Philadelphia, PA.
Semin Oncol Nurs. 2020 Apr;36(2):151004. doi: 10.1016/j.soncn.2020.151004. Epub 2020 Apr 4.
This article will provide an overview of the purpose, structure, and function of an investigational pharmacy in oncology clinical research. It will also discuss the role of the oncology nurse in managing investigational drugs (ID) when caring for a patient receiving treatment on a clinical trial and the importance of their role in the trial process.
Government regulations, professional guidelines, and best practices.
ID management for clinical trials is a multidisciplinary process requiring input from various professionals to ensure safe, accurate, and study-specific administration. The nurse's role in the process of clinical trial ID management is dependent on each institution's expectations of clinical research nurses and the scope of their role.
Multiple nursing roles may be involved in caring for patients who are being treated as part of a clinical trial, including clinical research nurses, infusion nurses, or as nurses providing direct patient care (inpatient or outpatient). Providing education on ID management, specific to the nurse's involvement, is a responsibility of the study team. Ensuring proper safeguards, accurate and protocol-specific delivery and documentation of ID, and completion of patient education are key in the conduct of oncology clinical research.
本文将概述肿瘤临床研究中研究药房的目的、结构和功能。还将讨论肿瘤护士在管理接受临床试验治疗的患者的研究药物 (ID) 时的作用，以及他们在试验过程中的重要性。
政府法规、专业准则和最佳实践。
临床试验的 ID 管理是一个多学科的过程，需要来自各种专业人员的投入，以确保安全、准确和特定于研究的管理。护士在临床试验 ID 管理过程中的作用取决于每个机构对临床研究护士的期望以及他们的角色范围。
在照顾作为临床试验一部分的患者时，可能涉及多个护理角色，包括临床研究护士、输液护士或直接提供患者护理的护士（住院或门诊）。提供特定于护士参与的 ID 管理教育是研究团队的责任。确保适当的保护措施、准确且符合方案的 ID 交付和文件记录，以及完成患者教育，是进行肿瘤临床研究的关键。
