Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development

Abstract

BackgroundClinical trials pose potential risks in both communications and management due to the various stakeholders involved when performing clinical trials. The academic medical center has a responsibility and obligation to conduct and manage clinical trials while maintaining a sufficiently high level of quality, therefore it is necessary to build an information technology system to support standardized clinical trial processes and comply with relevant regulations.ObjectiveThe objective of the study was to address the challenges identified while performing clinical trials at an academic medical center, Asan Medical Center (AMC) in Korea, by developing and utilizing a clinical trial management system (CTMS) that complies with standardized processes from multiple departments or units, controlled vocabularies, security, and privacy regulations.MethodsThis study describes the methods, considerations, and recommendations for the development and utilization of the CTMS as a consolidated research database in an academic medical center. A task force was formed to define and standardize the clinical trial performance process at the site level. On the basis of the agreed standardized process, the CTMS was designed and developed as an all-in-one system complying with privacy and security regulations.ResultsIn this study, the processes and standard mapped vocabularies of a clinical trial were established at the academic medical center. On the basis of these processes and vocabularies, a CTMS was built which interfaces with the existing trial systems such as the electronic institutional review board health information system, enterprise resource planning, and the barcode system. To protect patient data, the CTMS implements data governance and access rules, and excludes 21 personal health identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rule and Korean privacy laws. Since December 2014, the CTMS has been successfully implemented and used by 881 internal and external users for managing 11,645 studies and 146,943 subjects.ConclusionsThe CTMS was introduced in the Asan Medical Center to manage the large amounts of data involved with clinical trial operations. Inter- and intraunit control of data and resources can be easily conducted through the CTMS system. To our knowledge, this is the first CTMS developed in-house at an academic medical center side which can enhance the efficiency of clinical trial management in compliance with privacy and security laws.

A Good Practice–Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and Validation Study

“…During the 2000s, the FDA [4] was concerned about the objectivity and validity of imaging endpoints, since there were several critical issues such as reliability of imaging biomarker and results, and appropriateness of imaging data management with regard to GCP, FDA guidelines, and HIPAA. The FDA addressed this issue by developing the Clinical Trial Imaging Endpoint Process Standards Guidance for Industry.…”

“…Furthermore, medical imaging involvement in the recent clinical trials is another main reason for increasing the intricacies of clinical data [1-3]. These increased clinical data help develop information technology (IT) systems such as electronic data capture (EDC) systems or clinical trials management systems in order to access and collect data efficiently [4]. As a result, a separate dedicated IT system for imaging data is required to manage data and control any risk from the clinical trials because of increased medical imaging usage for various imaging endpoints in multicenter trials.…”

Utilization of Technology to Improve Efficiency in Investigational Drug Management Processes

“…This is beneficial for bigger operations where multiple pharmacists are working on the same clinical trial. 9 Finding solutions to problems concerning medical inventory is nothing new as medical professionals have been trying to tackle these issues for decades. 10 With advancement in technology, there are new solutions to old problems.…”

Review of Clinical Research Informatics

“…An oncology team at Vanderbilt and Rush reports on an ambitious framework capturing multiple aspects of clinical trial management, including evaluation [75]. Finally, a team from Seoul, Korea, reviews the creation, deployment, and evaluation of an entire Clinical Trial Management System which offers the full range of functions required for recruitment and full ethical and regulatory compliance [76].…”