임상시험자료 관리를 위한 전자문서 표준안 및 지침서 = Introduction to Electronic Document Standards and Guidelines for the Management, Exchange, and Submission of Clinical Trial Data

다국어 초록 (Multilingual Abstract)

Background and Objectives: Electronic documents provide cost-time benefits over paper documents generated during clinical trials. Electronic document standards and guidelines for management, exchange, and submission of clinical trial data are now being prepared by international standard organizations. As a step from paper based clinical trial toward electronic clinical trial, it is essential to keep up with international electronic document standards and guidelines.
Methods: We introduce electronic document standards and guidelines, which were discussed at the 18th Drug Information Association Electronic Document Annual Meeting. We first present the necessity of standards and guidelines related to electronic documents of clinical trial data. Next, we introduce
international standard organizations including ICH, CDISC, and regulatory agency like US FDA, and their standards and guidelines.
Results: ICH has developed guidelines for the registration of pharmaceuticals for human use. It has proposed two electronic document standards, Individual Case Safety Report and Electronic Common Technical Documents. US FDA posted final rules and drafts describing submission of data for new drug application in electronic format. CDISC develops models for submitting clinical trial data, operating institutions performing clinical trials, and generating metadata from statistical data.
Conclusion: The standards and guidelines related with electronic documents of clinical trial data presented by international standard organizations will play a key role in the era of electronic clinical trials. It is recommended to join the standardization movement while standards and guidelines are actively being prepared.