Efforts to Optimize Clinical Trial Management by Revising Deviation Reports and Classifying Deviation Cases for Efficient Clinical Trial Quality Improvement at Asahikawa Medical University Hospital

Masumi Ogawa, Takayuki Manabe, Yuko Kondo, Sachie Hatayama, Kanae Tani, Miyuki Sato, Mariko Yokoyama, Kazumi Yuki, Naoya Kamiyama, M. Honma, Yoshikazu Tasaki, S. Matsumoto
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Abstract

Face-to-face communication during on-site monitoring is important for clinical trial quality assurance. However, with the coronavirus disease early 2020 pandemic, medical institutions placed restrictions on hospital visits to secure their medical systems. Asahikawa Medical University Hospital similarly established restrictions on outpatient and inpatient visits and legal restrictions on outside vendors. Therefore, the frequency of on-site monitoring of clinical trials conducted at our hospital was reduced. Since there was no sign of convergence at the infection units even after 2 years, we investigated the frequency of on-site monitoring and the frequency of clinical trial deviations in the review of the system. In addition, although a clinical trial deviation report form (previous form)was prepared in the fiscal year 2019, there were many free descriptions, and many deviation reports were difficult to understand. Similarly, there were cases where deviations were not recorded on the deviation report form but only on article records (source documents), such as electronic medical records after consultation with the sponsor, and deviations were not recorded in a uniform format. Thus, the hospital experienced difficulty tabulating and classifying the number of deviation occurrences. Based on this experience, this report describes the progress of revising the clinical trial deviation report, clarifying the items to be included in the report, and establishing a system to clarify the process related to clinical trial deviation occurrences.Copyright: © 2023 the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT).
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通过修订偏差报告和分类偏差病例优化临床试验管理,有效提高旭川医科大学附属医院临床试验质量
现场监测期间的面对面沟通对临床试验质量保证至关重要。然而,随着2020年初冠状病毒大流行,医疗机构对医院就诊进行了限制,以确保其医疗系统的安全。旭川医科大学医院同样对门诊和住院病人进行限制,并对外部供应商进行法律限制。因此,减少了在我院进行临床试验的现场监测频率。由于即使在2年后感染单位也没有趋同的迹象,我们在系统审查中调查了现场监测的频率和临床试验偏差的频率。此外,虽然在2019财年编制了临床试验偏差报告表格(以前的表格),但其中有许多自由描述,并且许多偏差报告难以理解。同样,有些情况下,偏差没有记录在偏差报告表上,而只记录在物品记录(源文件)上,例如与申办方协商后的电子病历,并且偏差没有以统一的格式记录。因此,医院很难将偏离事件的数量制成表格并进行分类。根据这一经验,本报告描述了修订临床试验偏差报告、明确报告内容、建立制度明确临床试验偏差发生相关流程的进展情况。版权所有:©2023日本临床药理学和治疗学学会(JSCPT)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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