Applying for regulatory approval of a clinical trial of a medical device in the UK – A practical guide

Author:

Ria S.,Bakir A.,Abeysiri S.,Bister D.,Set P.,Navaie W.,Abela S.

Publisher

Springer Science and Business Media LLC

Subject

General Dentistry

Reference22 articles.

1. Kerr D J, Knox K, Robertson D, Stewart D, Watson R . Clinical trials explained: A guide to clinical trials in the NHS for healthcare professionals. John Wiley & Sons, 2008.

2. Medicines and Healthcare products Regulatory Agency. Notify MHRA about a clinical investigation for a medical device. 2018. Available at https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device (accessed February 2018).

3. Abozguia K, Phan T T, Shivu G N, Maher A, Ahmed I, Frenneaux M P . Insights into how to conduct a clinical trial in the UK. J R Soc Med 2007; 100: 469–472.

4. Silverman R, Kwiatkowski T . Research fundamentals: III. elements of a research protocol for clinical trials. Acad Emerg Med 1998; 5: 1218–1223.

5. Chan A W, Tetzlaff J M, Altman D G et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013; 158: 200–207.

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