作者
Lauren Houston, Colin H Cortie, Yasmine Probst, Barbara J Meyer
发表日期
2021/10
期刊
Clinical Trials
卷号
18
期号
5
页码范围
639-641
出版商
SAGE Publications
简介
The use of a data monitoring plan in clinical research protects participant safety, ensures data quality, and protects data integrity. Creating a data monitoring plan, however, is a significant investment of time and includes formalising staff roles and responsibilities, defining monitoring purpose, a communication plan, site contacts, types of visits (including the procedure, frequency and amount), essential documents (ie Master file), an overview of source documents, adequate training, qualifications and resources, and reporting needs (The International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guideline E6 (R2), Section 5.18. 7). Producing such a plan can be a significant burden on small research teams, and it is therefore unsurprising that a survey of 547 clinical researchers listed on the Australian and New Zealand Clinical Trial Registry found that most trials that did not meet the ICH guidelines for …
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