Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology

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Abstract

Aims: Researchers in clinical and pharmacoepidemiology fields have adopted information technology (IT) and electronic data capture, but these remain underutilised despite the benefits. This review discusses electronic case report forms and electronic data capture, specifically within pharmacoepidemiology and clinical research.

Methods: The review used PubMed and the Institute of Electrical and Electronic Engineers library (IEEE). Search terms used were agreed by the authors and documented. PubMed is medical and health based, whereas IEEE is technology based. The review focuses on electronic case report forms and electronic data capture, but considers briefly other relevant topics; consent, ethics, and security.

Results: One thousand, one hundred and twenty six papers were found using the search terms. Manual filtering and reviewing of abstracts further condensed this number to 136 relevant manuscripts. The papers were further categorised; 17 containing study data, 40 containing observational data, 27 anecdotal data, 47 covering methodology or design of systems, 1 case study, 1 literature review, 2 feasibility studies, and 1 cost analysis.

Conclusion: Electronic case report forms, electronic data capture, and IT in general, are viewed with enthusiasm and are seen as a cost effective means of improving research efficiency, educating participants, and improving trial recruitment, provided concerns about how data will be protected from misuse can be addressed. Clear operational guidelines and best practices are key for healthcare providers, and researchers adopting IT, and further work is needed on improving integration of new technologies with current systems. A robust method of evaluation for technical innovation is required.
Original languageEnglish
Pages (from-to)1880-1895
Number of pages16
JournalBritish Journal of Clinical Pharmacology
Volume83
Issue number9
Early online date9 Mar 2017
DOIs
Publication statusPublished - 14 Aug 2017

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Pharmacoepidemiology
Clinical Trials
Technology
PubMed
Libraries
Research Personnel
Costs and Cost Analysis
Manuscripts
Feasibility Studies
Practice Guidelines
Research
Ethics
Health Personnel
Guidelines
Health

Keywords

  • electronic case report form
  • electronic data capture

Cite this

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title = "Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology",
abstract = "Aims: Researchers in clinical and pharmacoepidemiology fields have adopted information technology (IT) and electronic data capture, but these remain underutilised despite the benefits. This review discusses electronic case report forms and electronic data capture, specifically within pharmacoepidemiology and clinical research.Methods: The review used PubMed and the Institute of Electrical and Electronic Engineers library (IEEE). Search terms used were agreed by the authors and documented. PubMed is medical and health based, whereas IEEE is technology based. The review focuses on electronic case report forms and electronic data capture, but considers briefly other relevant topics; consent, ethics, and security.Results: One thousand, one hundred and twenty six papers were found using the search terms. Manual filtering and reviewing of abstracts further condensed this number to 136 relevant manuscripts. The papers were further categorised; 17 containing study data, 40 containing observational data, 27 anecdotal data, 47 covering methodology or design of systems, 1 case study, 1 literature review, 2 feasibility studies, and 1 cost analysis.Conclusion: Electronic case report forms, electronic data capture, and IT in general, are viewed with enthusiasm and are seen as a cost effective means of improving research efficiency, educating participants, and improving trial recruitment, provided concerns about how data will be protected from misuse can be addressed. Clear operational guidelines and best practices are key for healthcare providers, and researchers adopting IT, and further work is needed on improving integration of new technologies with current systems. A robust method of evaluation for technical innovation is required.",
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author = "Rorie, {David A.} and Flynn, {Robert W. V.} and Kerr Grieve and Alexander Doney and Isla Mackenzie and MacDonald, {Thomas M.} and Amy Rogers",
note = "British Heart Foundation (GrantNumber(s): CS/14/1/30659; Grant recipient(s): THOMAS M. MACDONALD).",
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AU - Flynn, Robert W. V.

AU - Grieve, Kerr

AU - Doney, Alexander

AU - Mackenzie, Isla

AU - MacDonald, Thomas M.

AU - Rogers, Amy

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N2 - Aims: Researchers in clinical and pharmacoepidemiology fields have adopted information technology (IT) and electronic data capture, but these remain underutilised despite the benefits. This review discusses electronic case report forms and electronic data capture, specifically within pharmacoepidemiology and clinical research.Methods: The review used PubMed and the Institute of Electrical and Electronic Engineers library (IEEE). Search terms used were agreed by the authors and documented. PubMed is medical and health based, whereas IEEE is technology based. The review focuses on electronic case report forms and electronic data capture, but considers briefly other relevant topics; consent, ethics, and security.Results: One thousand, one hundred and twenty six papers were found using the search terms. Manual filtering and reviewing of abstracts further condensed this number to 136 relevant manuscripts. The papers were further categorised; 17 containing study data, 40 containing observational data, 27 anecdotal data, 47 covering methodology or design of systems, 1 case study, 1 literature review, 2 feasibility studies, and 1 cost analysis.Conclusion: Electronic case report forms, electronic data capture, and IT in general, are viewed with enthusiasm and are seen as a cost effective means of improving research efficiency, educating participants, and improving trial recruitment, provided concerns about how data will be protected from misuse can be addressed. Clear operational guidelines and best practices are key for healthcare providers, and researchers adopting IT, and further work is needed on improving integration of new technologies with current systems. A robust method of evaluation for technical innovation is required.

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