A qualitative survey on compliance with US FDA 21 code of federal regulation, part 11 in 13 Korean trial centers using the full electronic medical record system

Abstract

[한글]

[영문]This study is a qualitative research to investigate how the Electronic Medical Record (EMR) system is operated in clinical trial centers in Korea and evaluate their compliance with US FDA Code of Federal Regulation (CFR) Title 21, Part 11.There were 119 clinical trial centers registered at KFDA in 2009, but only 18 centers (15%) used a full EMR system. To assess their compliance with Part 11, questionnaires were sent to the 18 clinical trial centers using a full EMR system and 13 centers (72%) responded to the questionnaire survey. Of respondents, 8 centers (62%) were regional clinical research centers and 5 centers (38%) were not. The survey found that EMR systems used at 8 centers (62%) were 100% compliant with Part 11. Overall study participants showed 91.12% compliance. Categorical compliance was 88% for data and audit trail, 92.3% for system, 92.3% for training and 90.2% for security. This study shows some further improvements are required (i) to ensure a record of audit trail including date and time is available; (ii) to ensure the EMR system is regularly validated and the validation documents are maintained in accordance with a written policy on retention period; (iii) to ensure training records and EMR installation documents are available for all EMR users; (iv) to provide a written list of identification codes and passwords available to each authorization level; (v) to have an e-signature protection function from intentional or unintentional misuse with ‘cutting and pasting”; and (vi) to ensure re-signature is requested whenever any data is changed.