MODM coordination of clinical studies
THE TRAINING PROGRAM PROVIDES DUAL SKILLS IN THE FIELDS OF CLINICAL RESEARCH AND PROJECT MANAGEMENT. IT TRAINING SPECIALIZED CLINICAL RESEARCH EXECUTIVES: CLINICAL RESEARCH ASSISTANTS AND INTERNATIONAL CLINICAL TRIAL COORDINATORS.
OBJECTIVES
The objective is to train executives specializing in the field of Clinical Research Associate (CRA) in Master 1. The training is completed in Master 2 with Project Management to qualify for the position of International Clinical Study Coordinator. It is carried out on a work-study basis in large pharmaceutical companies.
Key strengths of the clinical trial coordination program
– Project-based learning
– Professional Integration
– Work-study program
– Professional speakers in person (40% in M1, 70% in M2)
– Student monitoring
SPECIFIC KNOWLEDGE GAINED THROUGH THE COURSE
Master's 1
- Therapeutic approaches
- Clinical trial monitoring and logistics:
-Regulatory environment, preclinical dossier, clinical dossier - Essential ICH documents for conducting trials (before, during, and at the end of the trial).
- Introduction to Clinical Database Management, CDISC Standards.
- Medical writing according to the ICH
Master's degree
- Project management, planning, and coordination in the conduct of international clinical trials
- Feasibility study, human and financial resource requirements
- Clinical data management, data management, risk-based monitoring, and GDPR
- Statistical methods applied to clinical trials
- Pharmacovigilance, management of adverse events
- Subcontracting management
SPECIFIC SKILLS ACQUIRED THROUGH THE PROGRAM
- Mastering Project Management: planning, cost management, deadlines, risks
- Develop, coordinate, monitor, and implement clinical studies
- Knowing how to conduct a feasibility study
- Mastering international regulations (ICH, FDA, CTD, etc.).
- Know the standard procedures
- Ensuring compliance, quality, and data management
- Understanding the statistical methodology of clinical trials
- Managing adverse events, pharmacovigilance
- Knowing how to write a clinical study report according to ICH guidelines
- Managing subcontracting in the sponsor-CRO relationship
- Respecting ethics in clinical trials
TEACHING RESOURCES AND PROFESSIONAL EXPERIENCE
- Educational Space for 3D Printing in Healthcare. Learning Lab, flipped classroom, interactive seminars, company visits, project-based learning, etc.
- Numerous external professional contributors
- M1 + M2 open to apprenticeships, schedules adapted to optimize practical training
CAREER OPPORTUNITIES
ARC, ARC MANAGER I CLINICAL TRIAL COORDINATOR I CLINICAL TRIAL MANAGER I CLINICAL PROJECT MANAGER
Download the route map the route
Video: interview with a student in both sixth-year pharmacy student and an M2 Clinical Operations Management student as part of INSIDE IS ISMA
all courses in the M1+M2 core curriculum (download)
all specific EUs for m2 (download)
Specific course units for MASTER 1 :
SEMESTER 1:
TU : THERAPEUTIC AXES – PHARMACOKINETICS – PEC
Number of ECTS credits = 5 – TU coordinator TU Patrice Ravel
Essential prerequisite:Physiology program(Bachelor's degree), Knowledge of how a clinical trial is conducted
Terms and conditions: 43.5 hours of lectures + 6 hours of tutorials
Objectives
-
- Provide students pursuing careers in clinical research with basic knowledge of the various therapeutic areas that are the subject of clinical studies.
- Understanding the pharmacokinetic profile
- Knowing how to present yourself orally and in writing
CONTENTS ofTU
THERAPEUTIC APPROACHES
Oncology, Cardiovascular, CNS, Pulmonology, Thrombosis, Diabetes, Hypertension, Hematology, Rheumatology, Psychiatry, Analgesics, Malaria, Infectious Diseases, Vaccine Trials, Medical Device Trials
PHARMACOKINETICS
Definition of the main variables involved in the conduct of phase 1 clinical development
PEC
Oral presentation by English and French students
Proofreading of CVs and cover letters
Teaching methods:
Lectures and tutorials
Assessment methods: Written exam
Speakers
Montpellier University and External Professionals
SEMESTER 2
TU : MONITORING AND LOGISTICS OF CLINICAL TRIALS
Number of ECTS credits = 5 – TU coordinator TU Patrice RAVEL
Essential prerequisite: This TU cannot TU separately from TU other TU to the program.
Terms and conditions: 41 hours of lectures + 6 hours of tutorials This TU reference hours (APP + hospital internship)
Objectives
- Provide students pursuing careers as Clinical Research Associates with the basic knowledge required to set up and monitor clinical trials in accordance with good clinical practices.
- Define the different phases of clinical trials.
- Present the role of Clinical Research Associate (CRA) and all of its responsibilities.
Content
Phase I, II, and III clinical trials
Clinical Trial Monitoring and Logistics
- Setup of the trial, protocol, observation log, e-CRF,
- Follow-up of monitoring visits from the first visit to the final visit.
- Investigators: recruitment, training, brochures
- Essential documents for conducting tests (before, during, and at the end of the test)
- Documents for submission to the HAS (ANSM, CPP, CNIL, etc.)
- Distribution of clinical batches
The players and professions involved in clinical research
- The profession of laboratory technician/hospital technician
- Structures involved in clinical research (CIC, URC, CRC, CRB, etc.),
Bioequivalence testing
- Testing for medical devices
Hospital Internship (4 weeks)
Speakers: External professionals
TU : REGULATORY AFFAIRS, BPC, PHARMACOVIGILANCE
Number of ECTS credits = 5 – TU coordinator TU Patrice RAVEL
Essential prerequisite: This TU cannot TU separated from the other TU to the course.
Terms and conditions: 32 hours of lectures + 6 hours of lectures + 3 hours of tutorials
Objectives
- Provide students pursuing careers in Clinical Research and Development with basic knowledge of the regulatory environment.
- Mastering Good Clinical Practices—ICH, CTD, FDA, EMEA, ANSM, CPP standardization, etc.
- Acquire the basics of pharmacovigilance and adverse effects.
- Provide the basics of clinical trial planning.
Content
- Regulatory environment for clinical trials
- Good Clinical Practices – ICH, CTD, FDA, EMEA, ANSM, CPP, etc. standardization
- Quality assurance and control in clinical research and audits
- Pharmacovigilance, serious and non-serious adverse events
- Operational planning
Teaching methods:
- Lectures, tutorials, and projects supervised by professionals.
Assessment methods:Written exam – Case study
Speakers
University of Montpellier and external professionals
TU : INTRODUCTION TO CLINICAL DATABASE MANAGEMENT – DATA MANAGEMENT
Number of ECTS credits=5 – TU supervisor TU Patrice RAVEL
Essential prerequisite:
This TU cannot TU separated from the other TU to the course.
Prerequisites in Statistics: Level L3 Health Engineering.
Objectives
- Introduction to clinical database management (Data Management)
- Know how to create a database from a CRF, understand the main controls related to data quality.
- Learn about data management and the main responsibilities of a data manager.
- Be familiar with the various tools for entering source data.
- Master the necessary basics of statistical analysis applied to clinical trials.
Content
Data Management
- Definition, the duties of the Data Manager
- Database structure, data quality control, base freeze
Introduction to the SAS language
- Creating tables, importing data files, using simple procedures for statistical analysis of clinical data.
Statistical methodology applied to clinical research
- Statistics Reminder
- Experimental designs: parallel designs, paired series designs, crossover designs, bioequivalence tests
Epidemiological studies
Medical writing
Teaching methods:
- Lectures, tutorials, practicals, and implementation of lessons learned through a supervised project on ACCESS
- 5 three-hour practical sessions on SAS software per student
Assessment methods:
- Written exam – SAS practical exam and continuous assessment
- Supervised project and written report
Speakers
University of Montpellier and External Professionals