Project management in clinical research
Main Article Content
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
Article Details
Section

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
How to Cite
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. DOI: 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. DOI: 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. DOI: 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. DOI: 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. DOI: 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. DOI: 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. DOI: 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. DOI: 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. DOI: 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. DOI: 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. DOI: 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. DOI: 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. DOI: https://doi.org/10.1007/978-3-319-18539-2
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. DOI: https://doi.org/10.1186/s13104-022-05908-5