External Data Transfers in Clinical Trials

This technical report discusses the integration of external data in clinical trials, focusing on the best practices and procedures for handling such data. It outlines the importance of external data for enhancing the quality of clinical trials and the challenges associated with incorporating this data into clinical databases. The report details the processing steps required for validation, editing, and verification of external data, emphasizing the significance of key variables. It also presents guidelines for establishing procedures for collecting, transferring, and validating external data, including the involvement of vendors early in the process. The document highlights the necessity of maintaining a documentation trail and applying quality control measures at each stage of data handling. Additionally, it describes the types of external data commonly used, such as laboratory data and electronic patient diaries, and stresses the importance of safeguarding data integrity and confidentiality throughout the process.