Wireless Clinical Trial of Data Capture using a Personal Digital Assistant

2009 ◽  
Vol 15 (2) ◽  
pp. 235 ◽  
Author(s):  
Sook-Kyoung Park ◽  
Soo-Heon Park ◽  
Min-Goo Kang ◽  
Young Moon Chae ◽  
Sukil Kim ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Personal Digital Assistant ◽  
Data Capture

OS 26-03 MOBILE DEVICE BASED ELECTRONIC DATA CAPTURE SYSTEM IN PHARMACEUTICAL CLINICAL TRIAL

2016 ◽  
Vol 34 (Supplement 1) ◽  
pp. e247
Author(s):  
Jing Zhang ◽  
Lei Sun ◽  
Yu Liu ◽  
Hongyi Wang ◽  
Ningling Sun ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mobile Device ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Electronic Data ◽  
Electronic Data Capture System

Symptom recording in a randomised clinical trial: paper diaries vs. electronic or telephone data capture

2004 ◽  
Vol 25 (6) ◽  
pp. 585-597 ◽  
Author(s):  
Karsten Lauritsen ◽  
Alessio Degl' Innocenti ◽  
Lene Hendel ◽  
Jørgen Præst ◽  
Mogens F. Lytje ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Clinical Trial ◽  
Data Capture

scholarly journals Personal Digital Assistant Data Capture: The Future of Quality of Life Measurement in Prostate Cancer Treatment

2007 ◽  
Vol 3 (3) ◽  
pp. 115-120 ◽  
Author(s):  
Andrew G. Matthew ◽  
Kristen L. Currie ◽  
Paul Ritvo ◽  
Robert Nam ◽  
Michael E. Nesbitt ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Health Care ◽  
Personal Digital Assistant ◽  
Data Capture ◽  
Questionnaire Data ◽  
Prostate Cancer Treatment ◽  
Paper Questionnaire ◽  
Hrqol Data ◽  
Potential Use

Purpose This article examines the potential use of personal digital assistant (PDA) data capture systems for real-time linear monitoring of health-related quality of life (HRQOL) in prostate cancer research and clinical care. Methods We discuss the benefits and potential issues of using PDA data capture in the clinical health care setting. In addition, we describe the development and potential use of a PDA data capture system specific to managing HRQOL in prostate cancer treatment. Conclusion Follow-up health care clinics require a practical and systematic process of HRQOL data capture and analysis. Traditional paper questionnaire data capture is problematic. Data manipulation required for clinical decision-making is impractical for patient feedback on same-day clinic visits. Furthermore, the process of transforming paper questionnaire data to analysis-quality data can compromise data integrity. In contrast, research findings confirm the acceptability, ease of use, and reliability of PDAs in capturing data across health care settings, including the collection of serial HRQOL data. The main concern for PDA capture systems is the ability to compare respondent's answers between the paper and PDA questionnaire. Other challenges included patients reporting a lack of computer literacy and/or poor eyesight, as well as initial start-up costs. If issues are successfully addressed, the use of a PDA data capture system, such as the PDA HRQOL system at Princess Margaret Hospital's Prostate Centre, allows for valid and economical data collection with the possibility of linear real-time measurement of changes in HRQOL. Accordingly, there appears to be significant potential for PDA data collection of serial HRQOL in prostate cancer clinic settings.

scholarly journals Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture Clinical Trial Database

2011 ◽  
Vol 45 (4) ◽  
pp. 421-430 ◽  
Author(s):  
Jules T. Mitchel ◽  
Yong Joong Kim ◽  
Joonhyuk Choi ◽  
Glen Park ◽  
Silvana Cappi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Data Entry ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Electronic Data ◽  
Clinical Trial Database ◽  
Evaluation Of Data

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>

scholarly journals Use of electronic data capture in a clinical trial on infant feeding

2012 ◽  
Vol 66 (12) ◽  
pp. 1342-1343 ◽  
Author(s):  
I Pawellek ◽  
T Richardsen ◽  
D Oberle ◽  
V Grote ◽  
B Koletzko
Keyword(s):  
Clinical Trial ◽  
Infant Feeding ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Electronic Data

Mobile access to virtual randomization for investigator-initiated trials

2017 ◽  
Vol 14 (4) ◽  
pp. 396-405
Author(s):  
Thomas M Deserno ◽  
András P Keszei
Keyword(s):  
Clinical Trial ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Trial Management ◽  
The Core ◽  
Mobile Access ◽  
Electronic Data Capture System ◽  
Investigator Initiated Trials ◽  
The Subject ◽  
Clinical Trial Management

Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization becomes available for investigator-initiated trials and potentially for large multi-center trials.

scholarly journals The experience of the clinical trial center at Alessandria Hospital regarding the activation of COVID-19 clinical trials during the pandemic

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Annalisa Roveta ◽  
Fabio Giacchero ◽  
Carolina Pelazza ◽  
Serena Penpa ◽  
Costanza Massarino ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Collection ◽  
Clinical Research ◽  
Fast Track ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Electronic Data ◽  
Web Based ◽  
Taking Charge

Objective: The aim is to evaluate the speed in the activation of Covid-19 clinical trials at SS. Antonio e Biagio e Cesare Arrigo Hospital of Alessandria during the pandemic. Methods: Data collection related to the activation and the conduction of clinical trials was managed using a database created through a web-based platform REDCap (Research Electronic Data Capture). Results: 32 studies were activated in the period between March 23 and July 31, 2020. An average time of 14 days elapsed between taking charge of the request and the issuance of the authorization act. Conclusions: During the emergency it was possible to activate the trials quickly thanks to fast-track procedures, optimizing COVID-19 clinical research.

P4-157: Adcs electronic data capture: Collaborative development and management of clinical trial databases

2013 ◽  
Vol 9 ◽  
pp. P763-P764
Author(s):  
Gustavo Jimenez-Maggiora ◽  
Ronald Thomas ◽  
Stefania Bruschi ◽  
Hongmei Qiu ◽  
Phuoc Hong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Electronic Data ◽  
Collaborative Development ◽  
Development And Management
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