Literature DB >> 30734683

Clinical Trial Data Management Software: A Review of the Technical Features.

Aynaz Nourani1, Haleh Ayatollahi2, Masoud Solaymani Dodaran3.   

Abstract

BACKGROUND: Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.
METHODS: Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.
RESULTS: Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.
CONCLUSION: It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.

Keywords:  Case Report Forms (CRFs); clinical data management; clinical trial; information technology; medical coding; systems software.

Mesh:

Year:  2019        PMID: 30734683     DOI: 10.2174/1574887114666190207151500

Source DB:  PubMed          Journal:  Rev Recent Clin Trials        ISSN: 1574-8871


  4 in total

1.  ProjectFlow: a configurable workflow management application for point of care research.

Authors:  Rupali Dhond; Danne Elbers; Nilla Majahalme; Svitlana Dipietro; Sergey Goryachev; Ryan Acher; Sarah Leatherman; Tori Anglin-Foote; Qingzhu Liu; Shaoyu Su; Ramana Seerapu; Robert Hall; Ryan Ferguson; Mary T Brophy; Jeff Ferraro; Scott L DuVall; Nhan V Do
Journal:  JAMIA Open       Date:  2021-09-02

2.  Data management in diabetes clinical trials: a qualitative study.

Authors:  Aynaz Nourani; Haleh Ayatollahi; Masoud Solaymani Dodaran
Journal:  Trials       Date:  2022-03-03       Impact factor: 2.279

3.  A Clinical Data Management System for Diabetes Clinical Trials.

Authors:  Aynaz Nourani; Haleh Ayatollahi; Masoud Solaymani-Dodaran
Journal:  J Healthc Eng       Date:  2022-02-24       Impact factor: 2.682

4.  The Open-Access European Prevention of Alzheimer's Dementia (EPAD) MRI dataset and processing workflow.

Authors:  Luigi Lorenzini; Silvia Ingala; Alle Meije Wink; Joost P A Kuijer; Viktor Wottschel; Mathijs Dijsselhof; Carole H Sudre; Sven Haller; José Luis Molinuevo; Juan Domingo Gispert; David M Cash; David L Thomas; Sjoerd B Vos; Ferran Prados; Jan Petr; Robin Wolz; Alessandro Palombit; Adam J Schwarz; Gaël Chételat; Pierre Payoux; Carol Di Perri; Joanna M Wardlaw; Giovanni B Frisoni; Christopher Foley; Nick C Fox; Craig Ritchie; Cyril Pernet; Adam Waldman; Frederik Barkhof; Henk J M M Mutsaerts
Journal:  Neuroimage Clin       Date:  2022-07-07       Impact factor: 4.891

  4 in total

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