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Advance Oracle Clinical Software tool used in clinical research from patient data collection to data base lock

机译：从患者数据收集到数据库锁定的临床研究中使用的高级Oracle临床软件工具

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摘要

This article is based on how the Oracle Clinical Software tool is used in clinical research. It is known that conducting research is a costly and time consuming process as it requires extra human resources, many software tools, and thorough knowledge of software in clinical research. This particular software helps in improving the trial performance and reduces the cost to the company. This article mainly describes the process of patient enrollment, data entry, data validation, E-data & SAE reconciliation, coding, discrepancy management, quality control process and data lock. Pharma Industries follow different methods for collecting, transferring, and storing patients data. Providing the knowledge of software tools to the persons who are involved in the trails will help them in simplifying their work. The objective is to provide complete knowledge of the Oracle Clinical Software tool by using proper guidelines of clinical trials. This also gives a complete idea of responsibilities and the functionality of data operation as well as tools analysis which would also help in tackling the risk profiles. All the above-mentioned applications would make one extract appropriate and consistent data of a patient, while submitting FDA.
机译：本文基于在临床研究中如何使用Oracle Clinical Software工具。众所周知，进行研究是一个昂贵且耗时的过程，因为它需要额外的人力资源，许多软件工具以及对临床研究中软件的全面了解。该特定软件有助于提高试用性能并降低公司成本。本文主要介绍患者注册，数据输入，数据验证，电子数据和SAE对帐，编码，差异管理，质量控制过程和数据锁定的过程。制药工业遵循不同的方法来收集，传输和存储患者数据。向参与试验的人员提供软件工具的知识将有助于他们简化工作。目的是通过使用适当的临床试验指南来提供有关Oracle Clinical Software工具的完整知识。这也给出了责任和数据操作功能以及工具分析的完整概念，这也将有助于解决风险状况。所有上述申请都将在提交FDA的同时提取患者的适当且一致的数据。

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