CLINICAL PROJECT MANAGEMENT
Delbeque Laure (12 h - 2 ECTS)
Theory: 12 h
Title | Clinical Project Management (2 ECTS) |
Program
|
Part I: Clinical project manager – Hard skills
Part II: Clinical project manager – Soft skills Part III: How to optimize clinical trials? |
Sources | • 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. |
Objectives and expected results | Introduction to the role, skills and responsibilities of a Clinical Project Manager. |
Prerequisites | Clinical Trials. |
Teaching methods | Ex Cathedra. |
Exam modality | Course participation, presentation and discussion of a peer-reviewed manuscript, home work (~ 3 pages reflection about a theme discussed during the courses). |
TITLE
Clinical Project Management (2 ECTS)
PROGRAM
Part I: Clinical project manager – Hard skills
Part II: Clinical project manager – Soft skills
Part III: How to optimize clinical trials?
SOURCES
- 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.
OBJECTIVES AND EXPECTED RESULTS
Introduction to the role, skills and responsibilities of a Clinical Project Manager.
PREREQUISITES
Clinical Trials.
TEACHING METHODS
Ex Cathedra.
EXAM MODALITY
Course participation, presentation and discussion of a peer-reviewed manuscript, home work (~ 3 pages reflection about a theme discussed during the courses).
Last modified: April 29, 2021