Quality Management in Clinical and Public Health Research: A Panacea for Minimising and Eliminating Protocol Deviations in Research Operations

Main Article Content

Elvis Efe Isere https://orcid.org/0000-0002-1047-2218
Nosa Eniye Omorogbe


Quality Management System, Protocol Deviation, Clinical Research, Public Health Research


A quality management system for clinical and public health research operations is indispensable because it ensures the integrity and reliability of research outcomes. By implementing a robust quality management practice in research implementation and operation, research teams can uphold the highest standard of research conduct, thereby enhancing the credibility and trustworthiness of research findings. This paper elucidates the significance and role of a quality management system in clinical and public health research operations and its efficacy in minimising and eliminating protocol deviations and highlights the key steps in setting up a quality management system for research operations.

Abstract 18 | PDF Downloads 16 EPUB Downloads 10


1. Federal Ministry of Health. National code of Health Research Ethics. Published August 2007. Retrieved from https://www.nhrec.net/nhrec/NCHRE_Aug%2007.pdf on 19/02/2024

2. Galuchie L, Stewart C, Meloni F. Protocol Deviations: A Holistic Approach from Defining to Reporting. Ther Innov Regul Sci. 2021;55(4):733-742.

3. Ghooi RB, Bhosale N, Wadhwani R, Divate P, Divate U. Assessment and classification of protocol deviations. Perspect Clin Res.

4. World Health Organisation (WHO). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: World Health Organization; 2011. Available from: https://www.ncbi.nlm.nih.gov/books/NBK310666/.

5. International Ethical Guidelines for Health-related Research Involving Humans, Fourth Edition. Geneva. Council for International Organizations of Medical Sciences (CIOMS); 2016.Available at:https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf.

6. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH Harmonised Guideline: Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6(R2).2016. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf

7. University of Hertfordshire. Standard Operating Procedure for the Development and Management of the Quality Management System for Clinical Research Studies 2018. Available on https://www.herts.ac.uk/__data/assets/pdf_file/0004/212458/2018-04-26-gsop-19-01qms-v1.1.pdf. Accessed on 18th Feb 2023

8. Kubiak C, de Andres-Trelles F, Kuchinke W, Huemer KH, Thirstrup S, Whitfield K, et al. Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN). Trials. 2009;10:95. doi: 10.1186/1745-6215-10-95.

9. Krishnankutty B, Bellary S, Kumar NB, Moodahadu LS. Data management in clinical research: An overview. Indian J Pharmacol 2012;44(2):168-72. doi: 10.4103/0253-7613.93842.

10. Doherty J. Quality Management in Clinical Research [PowerPoint presentation]. 2016, March 17. University of Maryland Baltimore. Retrieved from https://www.umaryland.edu/media/umb/oaa/hrp/documents/powerpoints/HL_Quality_Management_in_Research_03-17_2016.pdf.

11. Meeker-O'Connell A, Borda MM, Little JA, Sam LM. Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework: Concept Paper Vision and Outline. Ther Innov Regul Sci 2015;49(5):615-622.

12. Afifa F. Steps on implementing Clinical Quality Management System 2021. Available at: https://2kclinicalconsulting.com/steps-on-implementing-a-clinical-qms/ Accessed on 18/02/2023

13. Mohan S, Mehra M, Petrizzo M, Katz T. A Toolkit for the Management of Protocol Deviations. Ther Innov Regul Sci, 2016; 50: 791–800

14. Bhatt A. Protocol deviation and violation. Perspect Clin Res. 2012; 3:117

15. Jalgaonkar SV, Bhide SS, Tripathi RK, Shetty YC, Marathe PA, Katkar J, et al. An Audit of Protocol Deviations Submitted to an Institutional Ethics Committee of a Tertiary Care Hospital. PLoS ONE, 2016; 11(1): e0146334. https://doi.org/10.1371/journal.pone.0146334

16. Zemsi A, Nekame LJG, Mohammed N, Batchilly ES, Dabira E, Sillah SO. et al. Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa. Ther Innov Regul Sci (2024). https://doi.org/10.1007/s43441-023-00604-3

17. Chikezie P. The Importance of Standard Operating Procedures (SOPs) in Clinical Research: Enhancing Quality and Compliance. Published 20 July 2023. Accessed through https://infiuss.com/blog/the-importance-of-standard-operating-procedures-sops-in-clinical-research-enhancing-quality-and-compliance on 28/03/2024

18. Bailey D. Quality Management for Clinical Research Sites. Published 16 March 2021. Accessed through https://www.linkedin.com/pulse/quality-management-clinical-research-sites-dominic-bailey/ on 28/03/2024

19. DocXellent. The Four Main Components of a Quality Management System. Published in 2022 Available on https://info.docxellent.com/blog/main-components-quality-management. Accessed on 18/02/2024

20. DocXellent. The ultimate guide to implementing Quality Management System. Published in 2018 Available on https://info.docxellent.com/ultimate-guide-to-implementing-quality-management?_ga=2.249889990.1946705565.1663274984-698319519.1663274984. Accessed on 18/02/2024.