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


Autoria(s): McCarthy, Alexandra L.; Shaban, Ramon Z.
Data(s)

2013

Resumo

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.

Formato

image/tiff

application/pdf

application/pdf

Identificador

http://eprints.qut.edu.au/60757/

Publicador

RCN Publishing

Relação

http://eprints.qut.edu.au/60757/2/3_-_Figure_Only_19_Jan_2012.tiff

http://eprints.qut.edu.au/60757/8/60757.pdf

http://eprints.qut.edu.au/60757/9/60757%28table%29.pdf

http://web.ebscohost.com/ehost/detail?vid=2&sid=796b5b88-c039-4b19-82a3-fa24c4bd7c30%40sessionmgr11&hid=24&bdata=JnNpdGU9ZWhvc3QtbGl2ZQ%3d%3d#db=afh&AN=87545071

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.

Direitos

Copyright 2013 RCN Publishing

Fonte

Faculty of Health; Institute of Health and Biomedical Innovation; School of Nursing

Palavras-Chave #111099 Nursing not elsewhere classified #nurse led clinical trial #medical device #good clinical practice
Tipo

Journal Article