scholarly journals Web Based Data Capture for Clinical Research

10.28945/3201 ◽  
2008 ◽  
Author(s):  
Stephen Smith ◽  
Samuel Sambasivam
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Medical Device ◽  
Rapid Development ◽  
Research Data ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Proof Of Concept ◽  
Web Based ◽  
Tools And Techniques

Electronic Data Capture (EDC) is increasingly being used in the pharmaceutical, biotech and medical device industries to gather research data worldwide from doctors, hospitals and universities participating in clinical trials. In this highly regulated environment, all systems and software must be thoroughly tested and validated, a task that is burdensome in terms of time and cost. Starting with database structures that are designed to be copied easily, this paper proposes a simple framework that allows for rapid development and minimal testing. The framework includes tools for building modules, for copying modules from one trial to the next, and tools to validate that the modules are the same as modules that have been fully tested previously. A proof-of-concept prototype has been built to demonstrate certain tools and techniques that can be used when designing and building a simplified EDC interface.

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.

scholarly journals Research Electronic Data Capture (REDCap)

2018 ◽  
Vol 106 (1) ◽  
Author(s):  
Emily F. Patridge ◽  
Tania P. Bardyn
Keyword(s):  
Clinical Research ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Electronic Data ◽  
Web Based ◽  
Vanderbilt University

Research Electronic Data Capture (REDCap) is a web-based application developed by Vanderbilt University to capture data for clinical research and create databases and projects.

scholarly journals Using REDCap to track stakeholder engagement: A time-saving tool for PCORI-funded studies

2020 ◽  
Vol 4 (2) ◽  
pp. 108-114
Author(s):  
Sabina B. Gesell ◽  
Jacqueline R. Halladay ◽  
Laurie H. Mettam ◽  
Mysha E. Sissine ◽  
B. Lynette Staplefoote-Boynton ◽  
...  
Keyword(s):  
Stakeholder Engagement ◽  
Data Transfer ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Patient Centered ◽  
Electronic Data ◽  
Time Saving ◽  
Web Based ◽  
Pragmatic Clinical Trials ◽  
Cluster Randomized

AbstractBackground:Research Electronic Data Capture (REDCap) is a secure, web-based electronic data capture application for building and managing surveys and databases. It can also be used for study management, data transfer, and data export into a variety of statistical programs. REDcap was developed and supported by the National Center for Advancing Translational Sciences Program and is used in over 3700 institutions worldwide. It can also be used to track and measure stakeholder engagement, an integral element of research funded by the Patient-Centered Outcomes Research Institute (PCORI). Continuously and accurately tracking and reporting on stakeholder engagement activities throughout the life of a PCORI-funded trial can be challenging, particularly in complex trials with multiple types of engagement.Methods:In this paper, we show our approach for collecting and capturing stakeholder engagement activities using a shareable REDCap tool in one of the PCORI’s first large pragmatic clinical trials (the Comprehensive Post-Acute Stroke Services) to inform other investigators planning cluster-randomized pragmatic trials. Benefits and challenges are highlighted for researchers seeking to consistently monitor and measure stakeholder engagement.Conclusions:We describe how REDCap can provide a time-saving approach to capturing how stakeholders engage in a PCORI-funded study and reporting how stakeholders influenced the study in progress reports back to PCORI.

scholarly journals Simplifying Electronic Data Capture in Clinical Trials: Workflow Embedded Image and Biosignal File Integration and Analysis via Web Services

2014 ◽  
Vol 27 (5) ◽  
pp. 571-580 ◽  
Author(s):  
Daniel Haak ◽  
Christian Samsel ◽  
Johan Gehlen ◽  
Stephan Jonas ◽  
Thomas M. Deserno
Keyword(s):  
Clinical Trials ◽  
Web Services ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Electronic Data ◽  
Embedded Image

scholarly journals An Electronic Data Capture Framework (ConnEDCt) for Global and Public Health Research: Design and Implementation

10.2196/18580 ◽  
2020 ◽  
Vol 22 (8) ◽  
pp. e18580 ◽  
Author(s):  
Caleb J Ruth ◽  
Samantha Lee Huey ◽  
Jesse T Krisher ◽  
Amy Fothergill ◽  
Bryan M Gannon ◽  
...  
Keyword(s):  
Clinical Research ◽  
Data Storage ◽  
Data Entry ◽  
Public Health Research ◽  
Ease Of Use ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Electronic Data ◽  
Cross Sectional ◽  
Clinical Surveillance

Background When we were unable to identify an electronic data capture (EDC) package that supported our requirements for clinical research in resource-limited regions, we set out to build our own reusable EDC framework. We needed to capture data when offline, synchronize data on demand, and enforce strict eligibility requirements and complex longitudinal protocols. Based on previous experience, the geographical areas in which we conduct our research often have unreliable, slow internet access that would make web-based EDC platforms impractical. We were unwilling to fall back on paper-based data capture as we wanted other benefits of EDC. Therefore, we decided to build our own reusable software platform. In this paper, we describe our customizable EDC framework and highlight how we have used it in our ongoing surveillance programs, clinic-based cross-sectional studies, and randomized controlled trials (RCTs) in various settings in India and Ecuador. Objective This paper describes the creation of a mobile framework to support complex clinical research protocols in a variety of settings including clinical, surveillance, and RCTs. Methods We developed ConnEDCt, a mobile EDC framework for iOS devices and personal computers, using Claris FileMaker software for electronic data capture and data storage. Results ConnEDCt was tested in the field in our clinical, surveillance, and clinical trial research contexts in India and Ecuador and continuously refined for ease of use and optimization, including specific user roles; simultaneous synchronization across multiple locations; complex randomization schemes and informed consent processes; and collecting diverse types of data (laboratory, growth measurements, sociodemographic, health history, dietary recall and feeding practices, environmental exposures, and biological specimen collection). Conclusions ConnEDCt is customizable, with regulatory-compliant security, data synchronization, and other useful features for data collection in a variety of settings and study designs. Furthermore, ConnEDCt is user friendly and lowers the risks for errors in data entry because of real time error checking and protocol enforcement.

scholarly journals eSource for Standardized Health Information Exchange in Clinical Research: A Systematic Review of Progress in the Last Year

2021 ◽  
Author(s):  
Maryam Garza ◽  
Sahiti Myneni ◽  
Susan H. Fenton ◽  
Meredith Nahm Zozus
Keyword(s):  
Clinical Research ◽  
Information Exchange ◽  
Health Information Exchange ◽  
Data Capture ◽  
Health Record ◽  
Use Case ◽  
Electronic Data Capture ◽  
Single Source ◽  
Single Institution ◽  
Data Standards

To identify studies conductedusing the direct, electronic extraction of electronic health record (EHR) datato electronic data capture (EDC) systems, also known as eSource, and toidentify any gaps or limitations present for promoting standardized healthinformation exchange in clinical research.Materials and Methods:Articleswere included only if the solution described (1) utilized eSource to directlyexchange data electronically from EHR-to-EDC and (2) was relevant to aprospective clinical study use case.Results:Intotal, 20 relevant articles were identified, describing a total of 15 uniqueeSource interventions. Of the 15interventions, 12 were single-site, single-EHR (SS-SE) implementations and 3were multi-site, multi-EHR (MS-ME) implementations. All 15 implementationsmentioned the use of standards, but nearly all referenced older data exchangestandards.  Discussion:Following the trajectory of work towardsdirect EHR-to-EDC, eSource data collection, we appear to have arrived at thepoint where information systems leveraging data standards can offer efficiencyand increased quality in clinical research. However, these methods need to betested for effectiveness and acceptance in the context of real multicenterclinical trials. Several early studies using a single source of data forresearch and patient care appeared over a decade ago. Since that time,implementations and evaluations have been scarce and almost always confined tosingle-EHR, single-EDC, single-institution implementations.Conclusion:These results only further emphasize the observation thatthe clinical trial use case continues to be the most difficult and leastdemonstrated eSource-related initiative. Thus, additional work is criticallyneeded in this area to address the gaps identified from the literature.

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