At the end of the workshop, students will be able to:
Understand and explain the fundamental principles of project management applied to clinical research.
Identify the role, responsibilities and key skills of the Clinical Project Manager (CPM) throughout the different phases of a clinical trial.
Understand the project and clinical trial life cycles and the main challenges associated with planning and conducting a clinical research project.
Use or interpret key project planning and management tools, including the Work Breakdown Structure (WBS), Gantt charts and Project Plans.
Understand the key dimensions of clinical project management, including time, budget, quality, participant recruitment, monitoring and control.
Apply project management concepts to practical clinical research scenarios and case studies.
These outcomes expand upon the three learning objectives explicitly stated by ECCRT: understanding the fundamentals of clinical research project management, describing the CPM's role throughout the phases of a clinical trial, and becoming familiar with the tools used by a CPM
The overall objective of the workshop is to provide students with an operational understanding of clinical research project management, from project planning through implementation, monitoring and control.
More specifically, the course aims to familiarise students with the role of the Clinical Project Manager and with the organisational challenges involved in conducting clinical trials. Students are introduced to the different dimensions that need to be coordinated for successful project delivery, including timelines, resources, budget, quality, communication, teamwork and participant recruitment. The course also addresses key transversal project management skills, such as communication, team management and delegation
The workshop, organised by ECCRT (https://eccrt.com/) covers:
fundamentals of projects and project management, including the project life cycle and project environment;
the Project Manager's role and skills, including communication, team management and delegation;
the Clinical Trial Life Cycle;
project planning tools and techniques, including Work Breakdown Structure (WBS), Gantt charts and Project Plans;
time management;
budget management;
quality management;
participant recruitment and strategies for improving recruitment;
project monitoring and control;
application of these concepts through case scenarios and workshops.
The course will include different learning Activities:
The course follows a blended-learning approach, combining individual preparatory work with interactive face-to-face training.
Students first complete a two-hour e-learning module covering the fundamentals of project management, the project life cycle and environment, Project Manager skills and the clinical trial life cycle.
The classroom component subsequently uses an active learning approach combining theoretical review, trainer-led discussions, quizzes, case scenarios and workshops. Particular emphasis is placed on applying project management concepts to realistic clinical research situations, including a dedicated recruitment improvement workshop.
Written exam
Multiple-choice questions based on selected module
Recommended Reading Material:
• Regulation N° 536/2014 on clinical trials on medicinal products for human use, repealing directive 2001/20 EC - 16 April 2014: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.1…
• EU directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=URISERV:l14012
• What makes clinical research ethical? Ezekiel J. Emanuel and all; JAMA May 24/31, 2000 – Vol. 283 N°20
• Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA. (http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/…
• Global Clinical Trial Liability Insurance By Frank Goudsmit in Journal of Clinical research Best Pratices Vol. 9, No. 2, February 2013.
• GENERAL PRINCIPLES FOR PLANNING AND DESIGN OF MULTI-REGIONAL CLINICAL TRIALS E17 Current Step 2 version dated 6 May 2016 (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Ef…
• INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2) STEP 4 NOVEMBER 2016 (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Ef…
• Ensuring compliant TMF practices: common regulatory inspection pitfalls and how to avoid them. Sarah Ray, Senior Research Analyst at Cutting Edge Information. Cutting Edge White paper
• FDA Guidance: Use of Electronic Informed Consent, Questions and Answers. (https://www.fda.gov/downloads/drugs/guidances/ucm436811.pdf
| Training | Study programme | Block | Credits | Mandatory |
|---|---|---|---|---|
| Master in Biomedical Sciences | Filière en gestion de la recherche clinique | 2 | 2 | No |
| Master in Biomedical Sciences | Filière en recherche fondamentale et préclinique | 2 | 2 | No |
| Master in Biochemistry and Molecular and Cell Biology | Finalité approfondie | 2 | 2 | No |
| Master in Biochemistry and Molecular and Cell Biology | Finalité spécialisée | 2 | 2 | No |