Project management in clinical research

Article Sidebar

PDF (Spanish)
Published: 2022-12-29
DOI: https://doi.org/10.51987/revhospitalbaires.v42i4.241
Keywords:
research, clinical protocols, project management, clinical research

Main Article Content

María L. Posadas-Martínez
Instituto de Medicina Traslacional e Ingeniería Biomédica (IMTIB), CONICET - Instituto Universitario del Hospital Italiano de Buenos Aires - Hospital Italiano de Buenos Aires. Buenos Aires, Argentina

Abstract

The success of an investigation depends on the scientific and managerial aspects. Research projects are similar to other business projects. This manuscript reviews the application of the project management methodology of the project management institute applied to a research project in its initial, planning, implementation, monitoring and closure phases. There are 3 implementation challenges related to data recruitment, monitoring and management.

Downloads

Download data is not yet available.

Article Details

Issue

Vol. 42 No. 4 (2022): Revista del Hospital Italiano de Buenos Aires

Section

Notes on statistics and research
Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

How to Cite

1.
Posadas-Martínez ML. Project management in clinical research. Rev. Hosp. Ital. B.Aires [Internet]. 2022 Dec. 29 [cited 2025 Oct. 25];42(4):p. 264-266. Available from: https://ojs.hospitalitaliano.org.ar/index.php/revistahi/article/view/241

References

Files DC, Hume PS, Krall J, et al. Grant writing for clinicians in training: an important career development exercise. Chest. 2020;157(4):932-935. https://doi.org/10.1016/j.chest.2019.10.024.

Mackway-Jones K. Seeking funding for research. Emerg Med J. 2003;20(4):359-361. https://doi.org/10.1136/emj.20.4.359.

Farrell B, Kenyon S, Shakur H. Managing clinical trials. Trials. 2010;11:78. https://doi.org/10.1186/1745-6215-11-78.

Goodarzynejad H, Babamahmoodi A. Project management of randomized clinical trials: a narrative review. Iran Red Crescent Med J. 2015;17(8):e11602. https://doi.org/10.5812/ircmj.11602.

Blümle A, Meerpohl JJ, Schumacher M, et al. Fate of clinical research studies after ethical approval--follow-up of study protocols until publication. PLoS One. 2014;9(2):e87184. https://doi.org/10.1371/journal.pone.0087184.

Campbell MK, Snowdon C, Francis D, et al. Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health Technol Assess. 2007;11(48):iii, ix-105. https://doi.org/10.3310/hta11480.

Project Management Institute. A guide to the Project Management Body of Knowledge (Pmbok(r) Guide). 7th ed. Newtown Square, PA: Pmbok(r) Guide; 2021.

Centers for Disease Control and Prevention. Project management guide [Internet]. Atlanta, GA: CDC, [2007] [citado 2022 feb 11]. Disponible en: https://www2.cdc.gov/cdcup/library/pmg/default.htm.

Petrie KA, Carnahan RH, Brown AM, et al. Providing experiential business and management training for biomedical research trainees. CBE Life Sci Educ. 2017;16(3):ar51. https://doi.org/10.1187/cbe.17-05-0074.

Wikipedia. Project Management Institute [Internet]. Fundación Wikimedia; actualizado 2022 ago 10 [citado 2022 dic 19]. Disponible en: https://es.wikipedia.org/wiki/Project_Management_Institute.

Cao H, Shang H, Mu W, et al. Internal challenge to clinical trial project management: strategies for managing investigator compliance. J Evid Based Med. 2013;6(3):157-166. https://doi.org/10.1111/jebm.12053.

McCaskell DS, Molloy AJ, Childerhose L, et al. Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial. Trials. 2019;20(1):532. https://doi.org/10.1186/s13063-019-3634-7. Errata en: Trials. 2019;20(1):606. https://doi.org/10.1186/s13063-019-3716-6.

Arundel C, Gellatly J. Learning from OCTET - exploring the acceptability of clinical trials management methods. Trials. 2018;19(1):378. https://doi.org/10.1186/s13063-018-2765-6.

Chan YH. Randomised controlled trials (RCTs)--essentials. Singapore Med J. 2003;44(2):60-63.

Foot BJ, Sadi P. Research project management: managing clinical, health and operational research projects [video]. Singapur: Centre for Healthcare Innovation; 2019 [citado 2022 feb 11]. Disponible en: https://www.youtube.com/watch?v=oPaqxsVG8Mg.

Lazovic C. Basics - Part 23: jobs in clinical trials: clinical project manager [video]. GCP Mindset; 2021 [citado 2022 feb 11]. Disponible en: https://www.youtube.com/watch?v=tSO17j7lvj4.

Beukers MW. Project management of life-science research projects: project characteristics, challenges and training needs. Drug Discov Today. 2011;16(3-4):93-98. https://doi.org/10.1016/j.drudis.2010.11.015.

Pandi-Perumal SR, Akhter S, Zizi F, et al. Project stakeholder management in the clinical research environment: how to do it right. Front Psychiatry. 2015;6:71. https://doi.org/10.3389/fpsyt.2015.00071.

Fry A, Mortimer K, Ramsay L. Clinical research and the culture of collaboration. Aust J Adv Nurs. 1994;11(3):18-25.

Friedman LM, Furberg CD, Demets D, et al. Fundamentals of clinical trials. Cham: Springer: 2015.

Kanza S, Knight NJ. Behind every great research project is great data management. BMC Res Notes. 2022;15(1):20. https://doi.org/10.1186/s13104-022-05908-5.