Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology
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Aims: Researchers in clinical and pharmacoepidemiology fields have adopted information technology (IT) and electronic data capture, but these remain underused 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. Search terms used were agreed by the authors and documented. PubMed is medical and health based, whereas Institute of Electrical and Electronic Engineers is technology based. The review focuses on electronic case report forms and electronic data capture, but briefly considers other relevant topics; consent, ethics and security. Results: There were 1126 papers found using the search terms. Manual filtering and reviewing of abstracts further condensed this number to 136 relevant manuscripts. The papers were further categorized: 17 contained study data; 40 observational data; 27 anecdotal data; 47 covering methodology or design of systems; one case study; one literature review; two feasibility studies; and one 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 practises 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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Compared with paper based data collection, use of mobile devices and electronic data capture systems has the potential to improve protocol adherence, data accuracy, user acceptability, and timeliness of receiving data.
“Also, when compared with paper based data collection, the use of mobile devices and electronic data capture systems has the potential to improve protocol adherence, data accuracy, user acceptability, and timeliness of receiving data.385”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [385]
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Chandrashekar, B., Roopa, M. S., & Narayana, N. L. (2025) · International Journal of Clinical Trials · doi:10.18203/2349-3259.ijct20253341
- Authors
- Rorie, D. A., Flynn, R. W. V., Grieve, K., Doney, A., Mackenzie, I., MacDonald, T. M., & Rogers, A.
- Affiliations
- University of Dundee (GB)
- Ninewells Hospital and Medical School University of Dundee Dundee UK
- Corresponding author
- Rorie, David A.
- Venue
- British Journal of Clinical Pharmacology
- Publisher
- Wiley
- Published
- 2017-04-22
- Volume
- 83
- Issue
- 9
- Pages
- 1880-1895
- ISSN
- 0306-5251 (ISSN-L)
- 1365-2125
- PMC
- PMC5555865
- OpenAlex
- W2593616911
- Cited by
- 29
- References
- 70
- Citations by year
- 2026: 1 · 2025: 4 · 2023: 3 · 2022: 6 · 2021: 4 · 2020: 3 · 2019: 3 · 2018: 3 · 2017: 2
- FWCI
- 0.59
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- British Journal of Clinical Pharmacology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Discovery Research Portal (University of Dundee) (submittedVersion, cc-by)
- Funders
- British Heart Foundation (CS/14/1/30659)
- Topics
- Health Sciences › Health Professions › Health Information Management › Electronic Health Records Systems
- Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
- Social Sciences › Sociology and Political Science › Survey Methodology and Nonresponse
- Keywords
- electronic case report forms, electronic data capture, clinical trials, pharmacoepidemiology, information technology in research, data protection, research ethics, trial recruitment, research efficiency, technology integration
- MeSH terms
- Information Technology, Clinical Trials as Topic, Data Collection, Humans, Pharmacoepidemiology, Electronic Health Records
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