PDF(Pubmed)
Abstract：
UNASSIGNED: The traditional clinical trial data collection process requires a clinical research coordinator who is authorized by the investigators to read from the hospital\'s electronic medical record. Using electronic source data opens a new path to extract patients\' data from electronic health records (EHRs) and transfer them directly to an electronic data capture (EDC) system; this method is often referred to as eSource. eSource technology in a clinical trial data flow can improve data quality without compromising timeliness. At the same time, improved data collection efficiency reduces clinical trial costs.
UNASSIGNED: This study aims to explore how to extract clinical trial-related data from hospital EHR systems, transform the data into a format required by the EDC system, and transfer it into sponsors\' environments, and to evaluate the transferred data sets to validate the availability, completeness, and accuracy of building an eSource dataflow.
UNASSIGNED: A prospective clinical trial study registered on the Drug Clinical Trial Registration and Information Disclosure Platform was selected, and the following data modules were extracted from the structured data of 4 case report forms: demographics, vital signs, local laboratory data, and concomitant medications. The extracted data was mapped and transformed, deidentified, and transferred to the sponsor\'s environment. Data validation was performed based on availability, completeness, and accuracy.
UNASSIGNED: In a secure and controlled data environment, clinical trial data was successfully transferred from a hospital EHR to the sponsor\'s environment with 100% transcriptional accuracy, but the availability and completeness of the data could be improved.
UNASSIGNED: Data availability was low due to some required fields in the EDC system not being available directly in the EHR. Some data is also still in an unstructured or paper-based format. The top-level design of the eSource technology and the construction of hospital electronic data standards should help lay a foundation for a full electronic data flow from EHRs to EDC systems in the future.
UNASSIGNED: This study aims to explore how to extract clinical trial-related data from hospital EHR systems, transform the data into a format required by the EDC system, and transfer it into sponsors\' environments, and to evaluate the transferred data sets to validate the availability, completeness, and accuracy of building an eSource dataflow.
UNASSIGNED: A prospective clinical trial study registered on the Drug Clinical Trial Registration and Information Disclosure Platform was selected, and the following data modules were extracted from the structured data of 4 case report forms: demographics, vital signs, local laboratory data, and concomitant medications. The extracted data was mapped and transformed, deidentified, and transferred to the sponsor\'s environment. Data validation was performed based on availability, completeness, and accuracy.
UNASSIGNED: In a secure and controlled data environment, clinical trial data was successfully transferred from a hospital EHR to the sponsor\'s environment with 100% transcriptional accuracy, but the availability and completeness of the data could be improved.
UNASSIGNED: Data availability was low due to some required fields in the EDC system not being available directly in the EHR. Some data is also still in an unstructured or paper-based format. The top-level design of the eSource technology and the construction of hospital electronic data standards should help lay a foundation for a full electronic data flow from EHRs to EDC systems in the future.
摘要：
■传统的临床试验数据收集过程需要由研究者授权的临床研究协调员读取医院的电子病历。使用电子源数据为从电子健康记录（EHR）中提取患者数据并将其直接传输到电子数据捕获（EDC）系统开辟了一条新的途径；这种方法通常被称为eSource。临床试验数据流中的eSource技术可以在不影响及时性的情况下提高数据质量。同时,提高数据收集效率，降低临床试验成本。
■本研究旨在探索如何从医院EHR系统中提取临床试验相关数据，将数据转换为EDC系统所需的格式，并将其转移到赞助商的环境中，并评估传输的数据集以验证可用性，完整性，以及构建eSource数据流的准确性。
■选择在药物临床试验注册和信息披露平台注册的前瞻性临床试验研究，从4种病例报告表的结构化数据中提取以下数据模块:人口统计、生命体征,本地实验室数据,和伴随的药物。提取的数据被映射和转换，被取消身份，并转移到赞助商的环境中。数据验证是根据可用性进行的，完整性，和准确性。
■在安全和受控的数据环境中，临床试验数据成功地从医院EHR转移到申办者的环境，具有100%的转录准确性，但是数据的可用性和完整性可以提高。
■由于EDC系统中的某些必需字段无法直接在EHR中使用，因此数据可用性较低。一些数据也仍然是非结构化或基于纸张的格式。eSource技术的顶层设计和医院电子数据标准的构建将有助于为将来从EHR到EDC系统的完整电子数据流奠定基础。
■本研究旨在探索如何从医院EHR系统中提取临床试验相关数据，将数据转换为EDC系统所需的格式，并将其转移到赞助商的环境中，并评估传输的数据集以验证可用性，完整性，以及构建eSource数据流的准确性。
■选择在药物临床试验注册和信息披露平台注册的前瞻性临床试验研究，从4种病例报告表的结构化数据中提取以下数据模块:人口统计、生命体征,本地实验室数据,和伴随的药物。提取的数据被映射和转换，被取消身份，并转移到赞助商的环境中。数据验证是根据可用性进行的，完整性，和准确性。
■在安全和受控的数据环境中，临床试验数据成功地从医院EHR转移到申办者的环境，具有100%的转录准确性，但是数据的可用性和完整性可以提高。
■由于EDC系统中的某些必需字段无法直接在EHR中使用，因此数据可用性较低。一些数据也仍然是非结构化或基于纸张的格式。eSource技术的顶层设计和医院电子数据标准的构建将有助于为将来从EHR到EDC系统的完整电子数据流奠定基础。
