92090 Novel use of REDCap to develop a Crisis Management Decision-Support Portal at an Academic Medical Center

ABSTRACT IMPACT: Implementation of digital and mobile applications in clinical research crisis response protocols can mitigate their impact on clinical research. OBJECTIVES/GOALS: Crisis management is fundamental to ensuring the protection of human subjects during a clinical trial. Mobile apps have...

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Main Authors: Barbara Tafuto, Megha Master, Doreen Waldron Lechner
Format: Article
Language:English
Published: Cambridge University Press 2021-03-01
Series:Journal of Clinical and Translational Science
Online Access:https://www.cambridge.org/core/product/identifier/S2059866121004921/type/journal_article
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author Barbara Tafuto
Megha Master
Doreen Waldron Lechner
author_facet Barbara Tafuto
Megha Master
Doreen Waldron Lechner
author_sort Barbara Tafuto
collection DOAJ
description ABSTRACT IMPACT: Implementation of digital and mobile applications in clinical research crisis response protocols can mitigate their impact on clinical research. OBJECTIVES/GOALS: Crisis management is fundamental to ensuring the protection of human subjects during a clinical trial. Mobile apps have the capacity to allow for quick access to crisis response plans and can serve to mitigate their impact on clinical research. Electronic data capture tools can be used to create digital applications for such a response. METHODS/STUDY POPULATION: The Clinical Research Center at Rutgers University transferred a paper-based crisis management response plan to a digital mobile application format using Vanderbuilt’s Research Electronic Data Capture Tool (REDCap). REDCap’s branching logic allowed for programming a decision support functionality to guide users through 3 specific crises. (1) threatening or aggressive study subject behavior; (2) clinical research center break in or theft; and (3) adverse event observed for ongoing or closed clinical research study. Applicable U.S. Code of Federal Regulations, IRB guidelines, institutional policies and procedures were also used as a component of the mobile development. RESULTS/ANTICIPATED RESULTS: The Crisis Management Decision-Support Portal within the Clinical Research Center has an interactive structure. The use of branching logic demonstrates the ability for users to answer each question and be guided to appropriate responses specific to selected criteria related to each event. The tool contains a self-correct function by providing a reset option after answering each section. The portal itself can be accessed using any computer or cellphone with an internet connection. It provides the users with appropriate criteria to determine to exact communication and management protocols for reporting for the crisis event they are witnessing. As users access the portal, usage data can be collected, tracked, and stored. DISCUSSION/SIGNIFICANCE OF FINDINGS: The REDCap platform offers the opportunity to digitize crisis management protocols that ensure professionals have easy access to appropriate responses to crises at the center. The use a digital application rather than paper allows for a CTSA sponsored hub to mitigate damage, simply build new protocols, modify existing protocols, and track usage.
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spelling doaj.art-ce17d5ae5fef4f6aa10620329842abf82023-03-10T07:52:02ZengCambridge University PressJournal of Clinical and Translational Science2059-86612021-03-015343410.1017/cts.2021.49292090 Novel use of REDCap to develop a Crisis Management Decision-Support Portal at an Academic Medical CenterBarbara Tafuto0Megha Master1Doreen Waldron Lechner2Department of Health Informatics, School of Health Professions, Rutgers, The State University of New Jersey, Newark, NJDepartment of Health Informatics, School of Health Professions, Rutgers, The State University of New Jersey, Newark, NJDepartment of Health Informatics, School of Health Professions, Rutgers, The State University of New Jersey, Newark, NJABSTRACT IMPACT: Implementation of digital and mobile applications in clinical research crisis response protocols can mitigate their impact on clinical research. OBJECTIVES/GOALS: Crisis management is fundamental to ensuring the protection of human subjects during a clinical trial. Mobile apps have the capacity to allow for quick access to crisis response plans and can serve to mitigate their impact on clinical research. Electronic data capture tools can be used to create digital applications for such a response. METHODS/STUDY POPULATION: The Clinical Research Center at Rutgers University transferred a paper-based crisis management response plan to a digital mobile application format using Vanderbuilt’s Research Electronic Data Capture Tool (REDCap). REDCap’s branching logic allowed for programming a decision support functionality to guide users through 3 specific crises. (1) threatening or aggressive study subject behavior; (2) clinical research center break in or theft; and (3) adverse event observed for ongoing or closed clinical research study. Applicable U.S. Code of Federal Regulations, IRB guidelines, institutional policies and procedures were also used as a component of the mobile development. RESULTS/ANTICIPATED RESULTS: The Crisis Management Decision-Support Portal within the Clinical Research Center has an interactive structure. The use of branching logic demonstrates the ability for users to answer each question and be guided to appropriate responses specific to selected criteria related to each event. The tool contains a self-correct function by providing a reset option after answering each section. The portal itself can be accessed using any computer or cellphone with an internet connection. It provides the users with appropriate criteria to determine to exact communication and management protocols for reporting for the crisis event they are witnessing. As users access the portal, usage data can be collected, tracked, and stored. DISCUSSION/SIGNIFICANCE OF FINDINGS: The REDCap platform offers the opportunity to digitize crisis management protocols that ensure professionals have easy access to appropriate responses to crises at the center. The use a digital application rather than paper allows for a CTSA sponsored hub to mitigate damage, simply build new protocols, modify existing protocols, and track usage.https://www.cambridge.org/core/product/identifier/S2059866121004921/type/journal_article
spellingShingle Barbara Tafuto
Megha Master
Doreen Waldron Lechner
92090 Novel use of REDCap to develop a Crisis Management Decision-Support Portal at an Academic Medical Center
Journal of Clinical and Translational Science
title 92090 Novel use of REDCap to develop a Crisis Management Decision-Support Portal at an Academic Medical Center
title_full 92090 Novel use of REDCap to develop a Crisis Management Decision-Support Portal at an Academic Medical Center
title_fullStr 92090 Novel use of REDCap to develop a Crisis Management Decision-Support Portal at an Academic Medical Center
title_full_unstemmed 92090 Novel use of REDCap to develop a Crisis Management Decision-Support Portal at an Academic Medical Center
title_short 92090 Novel use of REDCap to develop a Crisis Management Decision-Support Portal at an Academic Medical Center
title_sort 92090 novel use of redcap to develop a crisis management decision support portal at an academic medical center
url https://www.cambridge.org/core/product/identifier/S2059866121004921/type/journal_article
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AT doreenwaldronlechner 92090noveluseofredcaptodevelopacrisismanagementdecisionsupportportalatanacademicmedicalcenter