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

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.

Data management in diabetes clinical trials: a qualitative study

“…However, it seems that these solutions are not enough to maintain data security and most data management systems use complementary methods such as role-based access control [ 45 – 47 ], data encryption [ 45 , 48 , 49 ], and event log files [ 15 , 49 ]. As data security maintenance is one of the important activities in the process of clinical data management [ 50 ], we suggest that attention needs to be paid to investigate users’ requirements and include related security features in the systems designed for any research institute.…”

Advance of Novel Coronavirus Registration Clinical Trial

“…Low blinding rate and lack of information may be related to it's. The detection or guidance of the data management committee should be further strengthened to improve the quality of research design [14].…”

A Clinical Data Management System for Diabetes Clinical Trials

“…Databases included Web of Science, Scopus, Science Direct, ProQuest, Ovid Medline, and PubMed. The search was conducted over a period of 10 years from 2007 to 2017 by one of the researchers (AN), and other researchers (HA) and (MSD) contributed to the review process [ 17 , 20 ]. In addition to the literature review, studies related to the diabetes clinical trials were reviewed to extract necessary data elements and functions for the system [ 44 – 47 ].…”

“…Clinical data management is the process of collecting and validating clinical trial data with the aim of conversion into an electronic format for performing statistical analysis, answering research questions, and ultimately preserving for future research [ 14 , 15 ]. In fact, this process enables researchers to make the right conclusions about the efficacy, safety, benefits, and potential risks of the product under a study by collecting and managing data properly, reducing missing data, and increasing data quality [ 16 , 17 ]. Clinical data management is a complex process and at least includes developing case report forms, annotating forms, creating databases, entering data, validating data, managing data discrepancies, medical coding, data mining, locking databases, documenting data management processes, and maintaining data security [ 16 , 18 – 20 ].…”