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Use of Information Technology to Mitigate Protocol Deviations in Clinical Research: A Quality Improvement Project.

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Τίτλος: Use of Information Technology to Mitigate Protocol Deviations in Clinical Research: A Quality Improvement Project.
Συγγραφείς: Hall KE; MGH Institute of Health Professions, 36 1st Avenue, Boston, MA, 02129-4557, USA., Bernhardt JM; MGH Institute of Health Professions, 36 1st Avenue, Boston, MA, 02129-4557, USA. jmbernhardt@mghihp.edu.
Πηγή: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2026 Jul; Vol. 60 (4), pp. 1068-1072. Date of Electronic Publication: 2026 Mar 21.
Τύπος έκδοσης: Journal Article
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE
Imprint Name(s): Publication: 2020- : Cham, Switzerland : Springer International Publishing
Original Publication: Thousand Oaks, CA : Sage Publications, [2013]-
Ιατρικοί όροι (MeSH): Biomedical Research*/standards , Quality Improvement* , Information Technology* , Clinical Protocols*, Humans ; Academic Medical Centers ; Documentation
Περίληψη: Introduction: Accurate vital sign (VS) documentation is essential in clinical research to ensure participant safety and data integrity. However, protocol deviations related to VS transcription and documentation remain a persistent challenge. This quality improvement project aimed to reduce VS-related protocol deviations through the implementation of monitor integration (MI) technology on an inpatient clinical research unit at an urban academic medical center.
Materials and Methods: Guided by Lewin's Change Management Model, the intervention included structured educational sessions for 31 clinical research nurses (CRNs), emphasizing protocol adherence, the use of MI to reduce documentation errors, and hands-on MI training. Peer support champions were designated to provide bedside guidance. A two-week audit compared VS-related protocol deviation rates from 451 pre-intervention and 682 post-intervention research visits.
Results: Following implementation, VS-related protocol deviations decreased significantly from 2.7% to 0.3% (p < 0.001). Nurse adoption of MI improved through targeted education and peer support, promoting alignment with Good Clinical Practice (GCP) guidelines and enhancing workflow efficiency.
Discussion: The combination of MI technology, training, and peer mentorship successfully reduced documentation errors and improved data quality. Despite initial resistance, CRNs adopted a new process, demonstrating the value of integrating technology into clinical workflows. Limitations include a short intervention period and the study's single institution setting.
Conclusion: MI technology, when paired with education and peer support, can reduce VS-related protocol deviations and strengthen research compliance. These findings support broader adoption of MI in clinical research settings and underscore the importance of continued investment in CRN education and health technology integration.
(© 2026. The Author(s), under exclusive licence to The Drug Information Association, Inc.)
Competing Interests: Declarations. Conflict of interest: The authors declare no conflict of interest.
References: Chodankar D. Impact of protocol deviations on the clinical study. Perspect Clin Res. 2023;14(2):47–8. https://doi.org/10.4103/picr.picr&#95;69&#95;23 . (PMID: 10.4103/picr.picr_69_233732557310267991)
Galuchie L, Stewart C, Meloni F. Protocol deviations: a holistic approach from defining to reporting. Ther Innov Regul Sci. 2021;55(4):733–42. https://doi.org/10.1007/s43441-021-00269-w . (PMID: 10.1007/s43441-021-00269-w337829218238759)
Kulkarni U, Vaswani R, Guthigar M, et al. Unreported protocol deviations–The tip of the research-berg. Perspect Clin Res. 2023;14(2):68–74. https://doi.org/10.4103/picr.picr&#95;235&#95;21 . (PMID: 10.4103/picr.picr_235_2137325575)
Breteler MJ, KleinJan EJ, Dohmen DA, et al. Vital signs monitoring with wearable sensors in high-risk surgical patients: a clinical validation study. Anesthesiol. 2020;132(3):424–39. https://doi.org/10.1097/ALN.0000000000003029 . (PMID: 10.1097/ALN.0000000000003029)
Mulac A, Mathiesen L, Taxis K, et al. Barcode medication administration technology use in hospital practice: a mixed-methods observational study of policy deviations. BMJ Qual Saf. 2021;30:1021–30. https://doi.org/10.1136/bmjqs-2021-013223 . (PMID: 10.1136/bmjqs-2021-013223342851148606443)
Mozersky JT, Antes AL, Baldwin K, et al. How do clinical research coordinators learn Good Clinical Practice? A mixed-methods study of factors that predict uptake of knowledge. Clin Trails. 2020;17(2):166–75. https://doi.org/10.1177/1740774519893301 . (PMID: 10.1177/1740774519893301)
Hornung CA, Kerr J, Gluck W, Jones CT. The competency of clinical research coordinators: the importance of education and experience. Ther Innov Regul Sci. 2021;55:1231–8. https://doi.org/10.1007/s43441-021-00320-w . (PMID: 10.1007/s43441-021-00320-w34189721)
Jones CT, Griffith CA, Fisher CA, et al. Nurses in clinical trials: perceptions of impact on the research enterprise. JRN. 2022;27(1–2):50–65. https://doi.org/10.1177/17449871211073757 . (PMID: 10.1177/17449871211073757353921868980586)
Núñez-Núñez M, Andrews JC, Fawzy M, et al. Research integrity in clinical trials: innocent errors and spin versus scientific misconduct. Cur Opin Obstet Gynecol. 2022;34(5):332–9. https://doi.org/10.1097/GCO.0000000000000807 . (PMID: 10.1097/GCO.0000000000000807)
Elliott M. The global elements of vital signs’ assessment: a guide for clinical practice. Br J Nurs. 2021;30(16):956–62. https://doi.org/10.12968/bjon.2021.30.16.956 . (PMID: 10.12968/bjon.2021.30.16.95634514822)
Khin NA, Francis G, Mulinde J, et al. Data integrity in global clinical trials: discussions from joint US food and drug administration and UK medicines and healthcare products regulatory agency good clinical practice workshop. Clin Pharm Ther. 2020;108(5):949–63. https://doi.org/10.1002/cpt.1794 . (PMID: 10.1002/cpt.1794)
Bertagnolli MM, Anderson B, Quina A, et al. The electronic health record as a clinical trials tool: opportunities and challenges. Clin Trails. 2020;17(3):237–42. https://doi.org/10.1177/1740774520913819 . (PMID: 10.1177/1740774520913819)
Hussain ST, Lei S, Akram T, et al. Kurt Lewin’s change model: A critical review of the role of leadership and employee involvement in organizational change. J Innov Knowl. 2018;3(3):123–7. https://doi.org/10.1016/j.jik.2016.07.002 . (PMID: 10.1016/j.jik.2016.07.002)
Burnes B. The origins of Lewin’s three-step model of change. J Appl Beh Sci. 2020;56(1):32–59. https://doi.org/10.1177/0021886319892685 . (PMID: 10.1177/0021886319892685)
Kleib M, Chauvette A, Furlong K, Nagle L, Slater L, McCloskey R. Approaches for defining and assessing nursing informatics competencies: a scoping review. JBI Evid Syn. 2021;19(4):794–841. https://doi.org/10.11124/JBIES-20-00100 . (PMID: 10.11124/JBIES-20-00100)
Hernon O, Dalton R, Dowling M. Clinical research nurses’ expectations and realities of their role: A qualitative evidence synthesis. J Clin Nurs. 2020;29(5–6):667–83. https://doi.org/10.1111/jocn.15128 . (PMID: 10.1111/jocn.1512831794099)
Akpoviroro O, Castagne-Charlotin M, Joyce NP, et al. Assessment of the relationship between protocol adherence, study complexity and personnel in surgical clinical trials. Ther Innov Regul Sci. 2023;57(4):619–28. https://doi.org/10.1007/s43441-023-00506-4 . (PMID: 10.1007/s43441-023-00506-436930415)
Contributed Indexing: Keywords: Clinical research nurses; Information technology; Protocol deviations
Entry Date(s): Date Created: 20260322 Date Completed: 20260710 Latest Revision: 20260710
Update Code: 20260711
DOI: 10.1007/s43441-026-00956-6
PMID: 41865155
Βάση Δεδομένων: MEDLINE
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  Data: Introduction: Accurate vital sign (VS) documentation is essential in clinical research to ensure participant safety and data integrity. However, protocol deviations related to VS transcription and documentation remain a persistent challenge. This quality improvement project aimed to reduce VS-related protocol deviations through the implementation of monitor integration (MI) technology on an inpatient clinical research unit at an urban academic medical center.&lt;br /&gt;Materials and Methods: Guided by Lewin&#39;s Change Management Model, the intervention included structured educational sessions for 31 clinical research nurses (CRNs), emphasizing protocol adherence, the use of MI to reduce documentation errors, and hands-on MI training. Peer support champions were designated to provide bedside guidance. A two-week audit compared VS-related protocol deviation rates from 451 pre-intervention and 682 post-intervention research visits.&lt;br /&gt;Results: Following implementation, VS-related protocol deviations decreased significantly from 2.7% to 0.3% (p &amp;lt; 0.001). Nurse adoption of MI improved through targeted education and peer support, promoting alignment with Good Clinical Practice (GCP) guidelines and enhancing workflow efficiency.&lt;br /&gt;Discussion: The combination of MI technology, training, and peer mentorship successfully reduced documentation errors and improved data quality. Despite initial resistance, CRNs adopted a new process, demonstrating the value of integrating technology into clinical workflows. Limitations include a short intervention period and the study&#39;s single institution setting.&lt;br /&gt;Conclusion: MI technology, when paired with education and peer support, can reduce VS-related protocol deviations and strengthen research compliance. These findings support broader adoption of MI in clinical research settings and underscore the importance of continued investment in CRN education and health technology integration.&lt;br /&gt; (&#169; 2026. The Author(s), under exclusive licence to The Drug Information Association, Inc.)
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  Data: Declarations. Conflict of interest: The authors declare no conflict of interest.
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  Label: References
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  Data: Chodankar D. Impact of protocol deviations on the clinical study. Perspect Clin Res. 2023;14(2):47–8. https://doi.org/10.4103/picr.picr&amp;#95;69&amp;#95;23 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E4103%2Fpicr%2Epicr%26#95%3B69%26#95%3B233732557310267991%22&quot;&gt;10.4103/picr.picr&amp;#95;69&amp;#95;233732557310267991)&lt;/searchLink&gt;&lt;br /&gt;Galuchie L, Stewart C, Meloni F. Protocol deviations: a holistic approach from defining to reporting. Ther Innov Regul Sci. 2021;55(4):733–42. https://doi.org/10.1007/s43441-021-00269-w . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E1007%2Fs43441-021-00269-w337829218238759%22&quot;&gt;10.1007/s43441-021-00269-w337829218238759)&lt;/searchLink&gt;&lt;br /&gt;Kulkarni U, Vaswani R, Guthigar M, et al. Unreported protocol deviations–The tip of the research-berg. Perspect Clin Res. 2023;14(2):68–74. https://doi.org/10.4103/picr.picr&amp;#95;235&amp;#95;21 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E4103%2Fpicr%2Epicr%26#95%3B235%26#95%3B2137325575%22&quot;&gt;10.4103/picr.picr&amp;#95;235&amp;#95;2137325575)&lt;/searchLink&gt;&lt;br /&gt;Breteler MJ, KleinJan EJ, Dohmen DA, et al. Vital signs monitoring with wearable sensors in high-risk surgical patients: a clinical validation study. Anesthesiol. 2020;132(3):424–39. https://doi.org/10.1097/ALN.0000000000003029 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E1097%2FALN%2E0000000000003029%22&quot;&gt;10.1097/ALN.0000000000003029)&lt;/searchLink&gt;&lt;br /&gt;Mulac A, Mathiesen L, Taxis K, et al. Barcode medication administration technology use in hospital practice: a mixed-methods observational study of policy deviations. BMJ Qual Saf. 2021;30:1021–30. https://doi.org/10.1136/bmjqs-2021-013223 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E1136%2Fbmjqs-2021-013223342851148606443%22&quot;&gt;10.1136/bmjqs-2021-013223342851148606443)&lt;/searchLink&gt;&lt;br /&gt;Mozersky JT, Antes AL, Baldwin K, et al. How do clinical research coordinators learn Good Clinical Practice? A mixed-methods study of factors that predict uptake of knowledge. Clin Trails. 2020;17(2):166–75. https://doi.org/10.1177/1740774519893301 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E1177%2F1740774519893301%22&quot;&gt;10.1177/1740774519893301)&lt;/searchLink&gt;&lt;br /&gt;Hornung CA, Kerr J, Gluck W, Jones CT. The competency of clinical research coordinators: the importance of education and experience. Ther Innov Regul Sci. 2021;55:1231–8. https://doi.org/10.1007/s43441-021-00320-w . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E1007%2Fs43441-021-00320-w34189721%22&quot;&gt;10.1007/s43441-021-00320-w34189721)&lt;/searchLink&gt;&lt;br /&gt;Jones CT, Griffith CA, Fisher CA, et al. Nurses in clinical trials: perceptions of impact on the research enterprise. JRN. 2022;27(1–2):50–65. https://doi.org/10.1177/17449871211073757 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E1177%2F17449871211073757353921868980586%22&quot;&gt;10.1177/17449871211073757353921868980586)&lt;/searchLink&gt;&lt;br /&gt;N&#250;&#241;ez-N&#250;&#241;ez M, Andrews JC, Fawzy M, et al. Research integrity in clinical trials: innocent errors and spin versus scientific misconduct. Cur Opin Obstet Gynecol. 2022;34(5):332–9. https://doi.org/10.1097/GCO.0000000000000807 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E1097%2FGCO%2E0000000000000807%22&quot;&gt;10.1097/GCO.0000000000000807)&lt;/searchLink&gt;&lt;br /&gt;Elliott M. The global elements of vital signs’ assessment: a guide for clinical practice. Br J Nurs. 2021;30(16):956–62. https://doi.org/10.12968/bjon.2021.30.16.956 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E12968%2Fbjon%2E2021%2E30%2E16%2E95634514822%22&quot;&gt;10.12968/bjon.2021.30.16.95634514822)&lt;/searchLink&gt;&lt;br /&gt;Khin NA, Francis G, Mulinde J, et al. Data integrity in global clinical trials: discussions from joint US food and drug administration and UK medicines and healthcare products regulatory agency good clinical practice workshop. Clin Pharm Ther. 2020;108(5):949–63. https://doi.org/10.1002/cpt.1794 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E1002%2Fcpt%2E1794%22&quot;&gt;10.1002/cpt.1794)&lt;/searchLink&gt;&lt;br /&gt;Bertagnolli MM, Anderson B, Quina A, et al. The electronic health record as a clinical trials tool: opportunities and challenges. Clin Trails. 2020;17(3):237–42. https://doi.org/10.1177/1740774520913819 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E1177%2F1740774520913819%22&quot;&gt;10.1177/1740774520913819)&lt;/searchLink&gt;&lt;br /&gt;Hussain ST, Lei S, Akram T, et al. Kurt Lewin’s change model: A critical review of the role of leadership and employee involvement in organizational change. J Innov Knowl. 2018;3(3):123–7. https://doi.org/10.1016/j.jik.2016.07.002 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E1016%2Fj%2Ejik%2E2016%2E07%2E002%22&quot;&gt;10.1016/j.jik.2016.07.002)&lt;/searchLink&gt;&lt;br /&gt;Burnes B. The origins of Lewin’s three-step model of change. J Appl Beh Sci. 2020;56(1):32–59. https://doi.org/10.1177/0021886319892685 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E1177%2F0021886319892685%22&quot;&gt;10.1177/0021886319892685)&lt;/searchLink&gt;&lt;br /&gt;Kleib M, Chauvette A, Furlong K, Nagle L, Slater L, McCloskey R. Approaches for defining and assessing nursing informatics competencies: a scoping review. JBI Evid Syn. 2021;19(4):794–841. https://doi.org/10.11124/JBIES-20-00100 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E11124%2FJBIES-20-00100%22&quot;&gt;10.11124/JBIES-20-00100)&lt;/searchLink&gt;&lt;br /&gt;Hernon O, Dalton R, Dowling M. Clinical research nurses’ expectations and realities of their role: A qualitative evidence synthesis. J Clin Nurs. 2020;29(5–6):667–83. https://doi.org/10.1111/jocn.15128 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E1111%2Fjocn%2E1512831794099%22&quot;&gt;10.1111/jocn.1512831794099)&lt;/searchLink&gt;&lt;br /&gt;Akpoviroro O, Castagne-Charlotin M, Joyce NP, et al. Assessment of the relationship between protocol adherence, study complexity and personnel in surgical clinical trials. Ther Innov Regul Sci. 2023;57(4):619–28. https://doi.org/10.1007/s43441-023-00506-4 . (PMID: &lt;searchLink fieldCode=&quot;PM&quot; term=&quot;%2210%2E1007%2Fs43441-023-00506-436930415%22&quot;&gt;10.1007/s43441-023-00506-436930415)&lt;/searchLink&gt;
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