Investigation and analysis of clinical trial research nurse to perform standard operating procedures

• Published in: Chinese nursing research Vol. 3; no. 2; pp. 77 - 79
• Main Authors: Lin, Yan, Wu, Yan-Yun, Wu, Mei-Hua, Yang, Xiu-Yu, Zhou, Ming
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 01.06.2016; Lymphoma/Head and Neck 0ncology Department, Fujian Province Cancer Hospital, Fuzhou, Fujian 350014, China%Nursing Department, Fujian Province Cancer Hospital, Fuzhou, Fujian 350014, China%Gastrointestinal 0ncology, Fujian Province Cancer Hospital, Fuzhou, Fujian 350014, China
• Subjects: Analysis; Clinical trial; Investigation; Nurse; Standard operating procedures (SOP); Investigation; Clinical trial; Analysis; Standard operating procedures (SOP); Nurse
• ISSN: 2095-7718
• DOI: 10.1016/j.cnre.2015.12.005

Objective： The aim of this study was to investigate the situations and factors that cause nurses not to follow standard operating procedures （SOPs） during the clinical trial process. Methods： Five cases involving patients enrolled in a clinical trial were divided into two groups, pre-SOP training and post-SOP training, to compare and observe the process problems and whether nurses fol- lowed SOPs in clinical trials. The causes of problems were analyzed and corrective measures were proposed. Results： Our results indicate significant improvement in compliance with SOPs after training. There were three occurrences of irregular behavior after training compared with 21 occurrences of irregular behavior before training. Conclusions： The quality of clinical trials can be improved if nurses strictly follow SOPs.