scholarly journals A Successful synchronized orchestration of an investigator-initiated multi-center trial through use of a clinical trial management system and team approach (Preprint)

10.2196/30368 ◽  
2021 ◽  
Author(s):  
Dinesh Pal Mudaranthakam ◽  
Alexandra Brown ◽  
Elizabeth H Kerling ◽  
Susan E Carlson ◽  
Christina J Valentine ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Management System ◽  
Team Approach ◽  
Trial Management ◽  
Clinical Trial Management

scholarly journals The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study (Preprint)

2021 ◽  
Author(s):  
Dinesh Pal Mudaranthakam ◽  
Alexandra Brown ◽  
Elizabeth Kerling ◽  
Susan E Carlson ◽  
Christina J Valentine ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Management System ◽  
Data Science ◽  
Medical Center ◽  
Phase 1 ◽  
Regulatory Compliance ◽  
Team Approach ◽  
Research Information ◽  
Trial Management ◽  
Clinical Trial Management

BACKGROUND As the cost of clinical trials continues to rise, novel approaches are required to ensure ethical allocation of resources. Multisite trials have been increasingly utilized in phase 1 trials for rare diseases and in phase 2 and 3 trials to meet accrual needs. The benefits of multisite trials include easier patient recruitment, expanded generalizability, and more robust statistical analyses. However, there are several problems more likely to arise in multisite trials, including accrual inequality, protocol nonadherence, data entry mistakes, and data integration difficulties. OBJECTIVE The Biostatistics & Data Science department at the University of Kansas Medical Center developed a clinical trial management system (comprehensive research information system [CRIS]) specifically designed to streamline multisite clinical trial management. METHODS A National Institute of Child Health and Human Development–funded phase 3 trial, the ADORE (assessment of docosahexaenoic acid [DHA] on reducing early preterm birth) trial fully utilized CRIS to provide automated accrual reports, centralize data capture, automate trial completion reports, and streamline data harmonization. RESULTS Using the ADORE trial as an example, we describe the utility of CRIS in database design, regulatory compliance, training standardization, study management, and automated reporting. Our goal is to continue to build a CRIS through use in subsequent multisite trials. Reports generated to suit the needs of future studies will be available as templates. CONCLUSIONS The implementation of similar tools and systems could provide significant cost-saving and operational benefit to multisite trials. CLINICALTRIAL ClinicalTrials.gov NCT02626299; https://tinyurl.com/j6erphcj

The pop-parent software system: A distributed data processing and clinical trial management system for the NHLBI BARI

1989 ◽  
Vol 10 (3) ◽  
pp. 339 ◽  
Author(s):  
William P. Amoroso ◽  
Donald Borrebach ◽  
Timothy E. Kuntz ◽  
Lawrence A. Kamons ◽  
Jeffrey Martin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Data Processing ◽  
Management System ◽  
Distributed Data ◽  
Software System ◽  
Trial Management ◽  
Distributed Data Processing ◽  
System A ◽  
Clinical Trial Management

scholarly journals Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development (Preprint)

2017 ◽  
Author(s):  
Yu Rang Park ◽  
Young Jo Yoon ◽  
HaYeong Koo ◽  
Soyoung Yoo ◽  
Chang-Min Choi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Management System ◽  
Medical Center ◽  
Academic Medical Center ◽  
Trial Management ◽  
Privacy And Security ◽  
Academic Medical ◽  
Asan Medical ◽  
Clinical Trial Management

BACKGROUND Clinical 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. OBJECTIVE The 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. METHODS This 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. RESULTS In 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. CONCLUSIONS The 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.

Implementing a low-cost web-based clinical trial management system for community studies: a case study

2011 ◽  
Vol 8 (5) ◽  
pp. 634-644 ◽  
Author(s):  
John Geyer ◽  
Kathleen Myers ◽  
Ann Vander Stoep ◽  
Carolyn McCarty ◽  
Nancy Palmer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Management System ◽  
Low Cost ◽  
Community Studies ◽  
Trial Management ◽  
Web Based ◽  
Clinical Trial Management

scholarly journals The first step to the powers for clinical trials: a survey on the current and future Clinical Trial Management System

2018 ◽  
Vol 26 (2) ◽  
pp. 86
Author(s):  
Jin-Sol Park ◽  
Seol Ju Moon ◽  
Ji-Hyoung Lee ◽  
Ji-Young Jeon ◽  
Kyungho Jang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Management System ◽  
Future Clinical Trial ◽  
Trial Management ◽  
Clinical Trial Management
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