scholarly journals Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?

PLoS Medicine ◽  
2008 ◽  
Vol 5 (3) ◽  
pp. e6 ◽  
Author(s):  
Greg W Fegan ◽  
Trudie A Lang
Keyword(s):  
Clinical Trial ◽  
Data Management ◽  
Open Source ◽  
Management System ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Data Management System

The development of CLINDATA, a clinical trial data management system

1981 ◽  
Vol 3 (3) ◽  
pp. 129-136 ◽  
Author(s):  
T. Ravenscroft ◽  
D.E. Smith
Keyword(s):  
Clinical Trial ◽  
Data Management ◽  
Management System ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Data Management System ◽  
Long Term Follow Up ◽  
On Line

The paper describes the design and implementation of a clinical trial data management system at the Wellcome Research Laboratories. Based on an IBM 3031 computer, the system provides the capability for on-line data input, search ing and comprehensive data analysis. The database also performs an adverse reaction reporting function and provides for long term follow-up of patients.

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

2019 ◽  
Vol 14 (3) ◽  
pp. 160-172 ◽  
Author(s):  
Aynaz Nourani ◽  
Haleh Ayatollahi ◽  
Masoud Solaymani Dodaran
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Data Management System ◽  
Management Systems ◽  
Data Management Systems ◽  
Technical Features

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.

scholarly journals CLINICAL DATA MANAGEMENT IMPORTANCE IN CLINICAL RESEARCH

2016 ◽  
pp. 59
Author(s):  
Deepa Murugesan ◽  
Ranganath Banerjee ◽  
Gopal Ramesh Kumar
Keyword(s):  
Clinical Trial ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Drug Approval ◽  
Trial Data ◽  
Data Capture ◽  
Data Management System ◽  
Pharmaceutical Companies ◽  
Management Tools

<p>ABSTRACT<br />Over the last few decades, most of the pharmaceutical companies and research sponsors are facing a lot of challenges in clinical research for their<br />new drug approval. The sponsor research needs a high-quality data report for getting new drug approval from Food and Drug Administration for their<br />medical products. Clinical trial data are important for the drug and medical device development processing pharmaceutical companies to examine<br />and evaluate the efficacy and safety of the new medical product in human volunteers. The results of the clinical trial studies generate the most<br />valuable data and in recent years; there has been massive development in the field of clinical trials. A good clinical data management system reduces<br />the duration of the study and cost of drug development. Further a well-designed case report form (CRF) assists data collection and make facilitates<br />data management and statistical analysis. Nowadays, the electronic data capture (EDC) is very beneficial in data collection. EDC helps to speed up the<br />clinical trial process and reduces the duration, errors and make the work easy in the data management system. This article highlights the importance<br />of data management processes involved in the clinical trial and provides an overview of the clinical trial data management tools. The study concluded<br />that data management tools play a key role in the clinical trial and well-designed CRFs reduces the errors and save the time of the clinical trials and<br />facilitates the drug discovery and development.<br />Keywords: Pharmaceutical, Clinical trial, Clinical data management, Data capture.</p>

UHF RFID proof of concept (POC) with open-source ILS at Universiti Sains Malaysia (USM) Libraries

2015 ◽  
Vol 49 (2) ◽  
pp. 135-150 ◽  
Author(s):  
JingHuey Khor ◽  
Widad Ismail ◽  
Mohd Nasir Md Rashid ◽  
A. Akla Wan Ismail ◽  
Muhammad Qayum Omar ◽  
...  
Keyword(s):  
Data Management ◽  
Open Source ◽  
Management System ◽  
Data Management System ◽  
Proof Of Concept ◽  
Rfid Technology ◽  
Uhf Rfid ◽  
Content Type ◽  
Library Automation ◽  
Detection Technologies

Purpose – Universiti Sains Malaysia (USM) uses different detection technologies and integrated library systems (ILS) at its four libraries located at different sites. Hence, ubiquitous data management system is required in the four libraries to enable real-time data sharing and tracking among the libraries. The paper aims to discuss these issues. Design/methodology/approach – Proof of concept is used to verify the performance of integration between different detection technologies including barcode, high frequency (HF) and ultra high frequency (UHF) radio frequency identification (RFID) as well as Integrated Library Management Utility (ILMU) and Koha ILSs. Five pilot tests are performed to investigate the speed of the borrowing and returning transactions, the efficiency of security gate to detect non-borrowed items, and the reliability of the ubiquitous data management system. Findings – The HF RFID technology and the proprietary library system have been used in many libraries. The current study proves that the integration of the UHF RFID technology and the Koha open-source ILS, which is named as Total Open-Source Library Automation Solution, can be a novel solution and can serve as a guide for other libraries. Originality/value – In the current phase of library data management system, it is common to integrate various technologies in improving the efficiency of the library system. But, the combination of Koha with UHF RFID into a single ILS for intra-library automation system has not been proven. This shows the importance of the proposed proven proof of concept that proves such integration is suitable to be implemented at USM libraries and other libraries.

scholarly journals Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres

Trials ◽  
2010 ◽  
Vol 11 (1) ◽  
Author(s):  
Wolfgang Kuchinke ◽  
Christian Ohmann ◽  
Qin Yang ◽  
Nader Salas ◽  
Jens Lauritsen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Data Management ◽  
Clinical Trial Data ◽  
Trial Data ◽  
The State

scholarly journals Data Validation and Verification Using Blockchain in a Clinical Trial for Breast Cancer: Regulatory Sandbox (Preprint)

2020 ◽  
Author(s):  
Tomonobu Hirano ◽  
Tomomitsu Motohashi ◽  
Kosuke Okumura ◽  
Kentaro Takajo ◽  
Taiyo Kuroki ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Research Process ◽  
Current Data ◽  
Data Management System ◽  
Blockchain Technology

BACKGROUND The integrity of data in a clinical trial is essential, but the current data management process is too complex and highly labor-intensive. As a result, clinical trials are prone to consuming a lot of budget and time, and there is a risk for human-induced error and data falsification. Blockchain technology has the potential to address some of these challenges. OBJECTIVE The aim of the study was to validate a system that enables the security of medical data in a clinical trial using blockchain technology. METHODS We have developed a blockchain-based data management system for clinical trials and tested the system through a clinical trial for breast cancer. The project was conducted to demonstrate clinical data management using blockchain technology under the regulatory sandbox enabled by the Japanese Cabinet Office. RESULTS We verified and validated the data in the clinical trial using the validation protocol and tested its resilience to data tampering. The robustness of the system was also proven by survival with zero downtime for clinical data registration during a Amazon Web Services disruption event in the Tokyo region on August 23, 2019. CONCLUSIONS We show that our system can improve clinical trial data management, enhance trust in the clinical research process, and ease regulator burden. The system will contribute to the sustainability of health care services through the optimization of cost for clinical trials.

Sign in / Sign up

Export Citation Format

Share Document