Learning outcomes

Introduction to the role, skills and responsibilities of a Clinical Project Manager

Goals

Become familiar with the role, skills and responsibilities of clinical project manager

Content

Part I:  Clinical project manager - Hard skills

Part II : Clinical project manager - Soft skills

Part III: How to optimize clinical trials?

Exercices

NA

Assessment method

  • course participation, presentation and discussion of a peer-reviewed manuscript, home work (~ 3 pages reflection about a theme discussed during the courses).

The exact modalities of the evaluation are likely to be modified during the preparation of the examination schedules, depending on the practical constraints with which the faculty administration may be confronted, or in the event of illness / force majeure / encroachment with an internship, or because of the health situation related to the coronavirus.

Sources, references and any support material

  • Ross J et al. (2012). Promoting transparency in pharmaceutical industry. American Journal of Public Health, vol 102, n1, 72-80
  • Pearce et al. (2015) Randomised trials in context: practical problems and social aspects of evidence-based medicine and policy. Trials, 16:394
  • Foster et al. (2015). Barriers and facilitators to patient recruitment to a cluster randomized controlled trial in primary care: lessons for future trials. BMC Medical Research Methodology 15:18.
  • Bleidorn et al. (2015). Why do – or don’t – patients with urinary tract infection participate in a clinical trial? A qualitative study in German family medicine. German Medical Science, 13.
  • Devidas Menon & Tania Stafinski (2011) Role of patient and public participation in health technology assessment and coverage decisions, Expert Review of Pharmacoeconomics & Outcomes Research, 11:1, 75-89.
  • Samyukta and Bhatt (2010): training needs of clinical research associates. Perspect Clin Res 2010; 1:134-138
  • Wright et al (2002). Factors that influence the recruitment of patients to Phase III studies in oncology. Cancer  2002;95:1584-91
  • Kurt et al (2017). Factors influencing participation in clinical trials :Emergency Medicine vs Other specialities, West J Emerg Med 1017;18:846-855

Language of instruction

Français