Gaps in electronic Trial Master File (eTMF) implementation: A study in the organization case

A Trial Master File (TMF) plays a significant role in clinical trials to comply with regulatory requirements. Many organizations involve clinical trials in the process of implementing Enterprise Content Management (ECM) called electronic eTMF. The concept of this study was based on concerns about the implementation of the eTMF system. This case study aimed to identify and gain in-depth understanding of the gaps in eTMF system implementation for organizations in Thailand. Interviews followed a semistructured questionnaire with fourteen users of the eTMF system, which were conducted to collect users’ opinions concerning eTMF system satisfaction, tool (named master list) application, eTMF management processes complexity, and user knowledge. Besides, the survey was conducted to assess user knowledge on master list application and eTMF management processes. The interview findings revealed that unsatis- fied search function of the eTMF system was the highest ranking gap. The second and third ranking gaps were the lack of understanding and the complexity of the master list, respectively. Lack of knowledge concerning the master list and eTMF system functions was ranked as the fourth-ranking gap. Lastly, repeating the processes of eTMF was the fifth-ranking gap. Also, the results of the user knowledge assessment con- firmed the lack of knowledge in eTMF management processes and the master list. Determining the critical gaps in system implementation would be useful for the application of suitable solutions. Future study will utilize practices, tools, and guidelines developed for success in system implementation with a knowledge management approach. An efficient knowledge management program allows the utilization of knowledge, including improving users' productivity and satisfaction.