Nurse-led trials of medical devices: General principles and good practice

McCarthy, Alexandra L. & Shaban, Ramon Z. (2013) Nurse-led trials of medical devices: General principles and good practice. Nurse Researcher, 20(5), pp. 21-27.

Image: TIFF (23kB)
[img] PDF (698kB)
Administrators only | Request a copy from author
[img] Tables (PDF 142kB)
Supplemental Material.
Administrators only | Request a copy from author

View at publisher


Aim To provide an overview of key governance matters relating to medical device trials and practical advice for nurses wishing to initiate or lead them.

Background Medical device trials, which are formal research studies that examine the benefits and risks of therapeutic, non-drug treatment medical devices, have traditionally been the purview of physicians and scientists. The role of nurses in medical device trials historically has been as data collectors or co-ordinators rather than as principal investigators. Nurses more recently play an increasing role in initiating and leading medical device trials.

Review Methods A review article of nurse-led trials of medical devices.

Discussion Central to the quality and safety of all clinical trials is adherence to the International Conference on Harmonization Guidelines for Good Clinical Practice, which is the internationally-agreed standard for the ethically- and scientifically-sound design, conduct and monitoring of a medical device trial, as well as the analysis, reporting and verification of the data derived from that trial. Key considerations include the class of the medical device, type of medical device trial, regulatory status of the device, implementation of standard operating procedures, obligations of the trial sponsor, indemnity of relevant parties, scrutiny of the trial conduct, trial registration, and reporting and publication of the results.

Conclusion Nurse-led trials of medical devices are demanding but rewarding research enterprises. As nursing practice and research increasingly embrace technical interventions, it is vital that nurse researchers contemplating such trials understand and implement the principles of Good Clinical Practice to protect both study participants and the research team.

Impact and interest:

0 citations in Scopus
Search Google Scholar™

Citation counts are sourced monthly from Scopus and Web of Science® citation databases.

These databases contain citations from different subsets of available publications and different time periods and thus the citation count from each is usually different. Some works are not in either database and no count is displayed. Scopus includes citations from articles published in 1996 onwards, and Web of Science® generally from 1980 onwards.

Citations counts from the Google Scholar™ indexing service can be viewed at the linked Google Scholar™ search.

Full-text downloads:

11 since deposited on 12 Jun 2013
1 in the past twelve months

Full-text downloads displays the total number of times this work’s files (e.g., a PDF) have been downloaded from QUT ePrints as well as the number of downloads in the previous 365 days. The count includes downloads for all files if a work has more than one.

ID Code: 60757
Item Type: Journal Article
Refereed: Yes
Keywords: nurse led clinical trial, medical device, good clinical practice
ISSN: 2047-8992
Subjects: Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > NURSING (111000) > Nursing not elsewhere classified (111099)
Divisions: Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Current > Schools > School of Nursing
Copyright Owner: Copyright 2013 RCN Publishing
Deposited On: 12 Jun 2013 22:48
Last Modified: 21 Sep 2015 18:04

Export: EndNote | Dublin Core | BibTeX

Repository Staff Only: item control page