一份模型数据管理计划标准操作规程：来自DIA临床数据管理社区临床数据管理计划委员会的结果
A Model Data Management Plan Standard Operating Procedure: Results From the DIA Clinical Data Management Community, Committee on Clinical Data Management Plan.
作者信息
Brand Scott, Bartlett Diana, Farley Mary, Fogelson Miriam, Hak Jan Bart, Hu Grace, Montana Olivia D, Pierre Jan Holladay, Proeve Johann, Qureshi Samina, Shen Anita, Stockman Peter, Chamberlain Richard, Neff Kristin
机构信息
1 QPS LLC, Newark, DE, USA.
Committee chair.
出版信息
Ther Innov Regul Sci. 2015 Sep;49(5):720-729. doi: 10.1177/2168479015579520.
BACKGROUND
The DIA Clinical Data Management Community created a committee to develop a model standard operating procedure (SOP) for writing a data management plan.
METHODS
The goal of the committee was to develop a plan that could be used by industry and academic institutions. The model was based on contributed examples from committee members and their experiences with current practices and technologies. It is understood that as new clinical trial technology is implemented, the SOP will require modification.
RESULTS
The model SOP and associated templates are presented as a starting point, and each company or institution will need to modify them to meet its individual needs.
CONCLUSION
The model DMP SOP produced addresses most data management issues that are present in any phase clinical trial while providing a flexible framework.
背景
DIA临床数据管理社区成立了一个委员会，以制定撰写数据管理计划的标准操作规程（SOP）模型。
方法
委员会的目标是制定一个可供行业和学术机构使用的计划。该模型基于委员会成员提供的示例以及他们在当前实践和技术方面的经验。可以理解的是，随着新的临床试验技术的实施，该SOP将需要修改。
结果
呈现了标准操作规程模型及相关模板作为起点，每个公司或机构都需要对其进行修改以满足自身需求。
结论
所产生的DMP标准操作规程模型解决了任何阶段临床试验中存在的大多数数据管理问题，同时提供了一个灵活的框架。
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