Clinical Data Management System

Fu, Lingli; Ding, Shilei; Chen, Tao

doi:10.1109/icbecs.2010.5462386

Cited by 5 publications

(3 citation statements)

References 2 publications

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“…Therefore, it is better to prepare this report readable for statistical software such as SPSS and SAS. Similarly, in the present study and other similar research studies [ 30 , 32 , 33 ], CSV and SPSS files were used to extract and report the data and to facilitate analyzing data processes.…”

Section: Discussionmentioning

confidence: 98%

A Clinical Data Management System for Diabetes Clinical Trials

Nourani

Ayatollahi

Solaymani‐Dodaran

2022

Journal of Healthcare Engineering

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Background. The use of novel medications and methods to prevent, diagnose, treat, and manage diabetes requires confirmation of safety and efficacy in a well-designed study prior to widespread adoption. Diabetes clinical trials are the studies that examine these issues. The aim of the present study was to develop a web-based system for data management in diabetes clinical trials. Methods. The present research was a mixed-methods study conducted in 2019. To identify the required data elements and functions to develop the system, 60 researchers completed a questionnaire. The designed system was evaluated using two methods. The usability of the system was initially evaluated by a group of researchers (n = 6) using the think-aloud method, and after system improvement, the system functions were evaluated by other researchers (n = 30) using a questionnaire. Results. The main data elements which were required to develop a case report form included “study data,” “participant’s personal data,” and “clinical data.” The functional requirements of the system were “managing the study,” “creating case report forms,” “data management,” “data quality control,” and “data security and confidentiality.” After using the system, researchers rated the system functions at a “good” level (6.3 ± 0.73) on a seven-point Likert scale. Conclusion. Given the complexity of the data management processes in diabetes clinical trials and the widespread use of information technologies in research, the use of clinical data management systems in diabetes clinical trials seems inevitable. The system developed in the current study can facilitate and improve the process of creating and managing case report forms as well as collecting data in diabetes clinical trials.

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Section: Discussionmentioning

confidence: 98%

A Clinical Data Management System for Diabetes Clinical Trials

Nourani

Ayatollahi

Solaymani‐Dodaran

2022

Journal of Healthcare Engineering

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“…These systems support various aspects of data management, reduce financial and manpower costs, and facilitate data collection and management by eliminating manual processes and reducing workload [32,35,36]. However, many systems have not been properly evaluated in terms of quality, usability, and impact [21,[37][38][39][40][41][42]. Therefore, conducting evaluation studies is of paramount importance [16].…”

Section: Discussionmentioning

confidence: 99%

Data management system for diabetes clinical trials: a pre-post evaluation study

Nourani

Ayatollahi²,

Solaymani‐Dodaran³

2023

BMC Med Inform Decis Mak

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Background Data management system for diabetes clinical trials is used to support clinical data management processes. The purpose of this study was to evaluate the quality and usability of this system from the users’ perspectives. Methods This study was conducted in 2020, and the pre-post evaluation method was used to examine the quality and usability of the designed system. Initially, a questionnaire was designed and distributed among the researchers who were involved in the diabetes clinical trials (n = 30) to investigate their expectations. Then, the researchers were asked to use the system and explain their perspectives about it by completing two questionnaires. Results There was no statistically significant differences between the users’ perspectives about the information quality, service quality, achievements, and communication before and after using the system. However, in terms of the system quality (P = 0.042) and users’ autonomy (P = 0.026), the users’ expectations were greater than the system performance. The system usability was at a good level based on the users’ opinions. Conclusion It seems that the designed system largely met the users’ expectations in most areas. However, the system quality and users’ autonomy need further attentions. In addition, the system should be used in multicenter trials and re-evaluated by a larger group of users.

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“…As shown in table 1, this is an easy example only including informed consent, inclusion and exclusion criteria, some normal information, lab investigations, and adverse event (AE). We can through this simple example to describe how to design the clinical trial projects in electronic way [5]. Informed consent and adverse event are the most important parameters in each clinical trial.…”

Section: Day -3 Day 1 Day 7 Day 14mentioning

confidence: 99%

Web-Based Case Report Form Design for Clinical Trial

Chen

2010

AMM

Self Cite

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With more clinical trials using electronic way, new drugs electronic application has becoming an inevitable trend in near future. A well-designed case report form (CRF) is the premise of high quality clinical trials which facilitates data collection and entry, and directly benefits other facets of clinical data management. Firstly, paper introduces the CRF design modes and design principles. Then paper describes the CRF design process, and based on this, paper constructs the data structure with CDISC ODM concept. Lastly, paper explores how to convert the paper CRF to electronic format in web application with SAS statistic requirements in detail.

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Clinical Data Management System

Cited by 5 publications

References 2 publications

A Clinical Data Management System for Diabetes Clinical Trials

A Clinical Data Management System for Diabetes Clinical Trials

Data management system for diabetes clinical trials: a pre-post evaluation study

Web-Based Case Report Form Design for Clinical Trial

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