It includes 2 modules:
Module of academic course (obligatory):
o 112 hours for the UD of the "Fundamentals in Medical Research"
o 80 hours for the CRA "Clinical Research Assistant" and CRT "Clinical Research Technician"
Module consisting in a minimum of 2 weeks of professional training. This training is optional for persons working in research units.
Modules in blue are specific to the UD;
Modules in black are common to the UD (post-doc) and to the professional certificate of CRA and CRT (Bac +3)
THE ACADEMIC COURSES
MODULE 1/ November 7
th& 8
th2014
Biology and New therapeutic approaches
Friday7
16h00- 17h00 Cardiology (Pr Roland Asmar)
17h00 – 18h00 Neurology – Psychiatry (Dr. Wadih Naja) 18h00 –19h30 Introduction (Dr Mirna Chahine)
Saturday 8
8h30– 9h30 Gastroenterology (Dr. Antoine Abi Rached) 9h30 – 11h00 Hematology – Immunology (Dr. Adlette Inati)
11h00 – 12h00 Oncology (Dr. Fadi Nasr)
MODULE 2/ November 28
th& 29
th2014
Friday 28
Biology and New therapeutic approaches
16h00 – 17h00 Endocrinology- Diabetology (Dr Zelia Francis) Research bases and methodology
17h00– 19h00 Safeguarding of persons participating in research studies, Ethics committees, Declaration of Helsinki, regulation; Responsibilities and insurance: manufacturer, investigator, hospital, patient.
(Me Charles Ghafari)
Saturday 29
Biology and New therapeutic approaches
8h30 – 9h30 Pulmonary (Dr. Wajdy Abi Saleh) Biology and New therapeutic approaches
9h30 – 12h00 Genome and Therapy (Dr. Rana Bazzi) Research bases and methodology
13h30 – 16h30 Biomedical Ethics (Dr. Mirna Chahine)
2014 -2015
FUNDAMENTALS
IN MEDICAL RESEARCH
MODULE 3/ December 12
th& 13
th2014
Friday 12
Biology and New therapeutic approaches
16h – 17h00 Infectious diseases (Dr. Nadine Yared) 17h00 – 18h00 Urology – Nephrology (Dr. Jose Khabout)
Research bases and methodology
18h15 – 19h30 Application of Basic medical research into Pre-Clinical medical research (Dr. Mirna Chahine)
Saturday 13
Pharmacology
9h – 11h00 Pharmacokinetics – Pharmacodynamics (Dr Issam Kassab)
Toxicity – Tolerability- Basic knowledge on pharmacogenetics (Dr Issam Kassab) Drug development – Preclinical and clinical development
11h15 – 13h15 Animal experimentation
Studies in human, the various phases of clinical trials: preclinical phase, phase I (Dr Issam Kassab)
14h30 – 16h30 Animal experimentation
Studies in human, the various phases of clinical trials: preclinical phase, phase I (Dr Issam Kassab)
16h45 – 18h45 Studies in human, the various phases of clinical trials: phases II, III & IV, post-marketing studies, morbi-mortality studies. (OVERVIEW)
(Dr Issam Kassab)
MODULE 4/ January 9
th& 10
th2015
Friday 9
Quality
17h – 20h30 Quality management in clinical research (Manual and procedures: quality assurance, quality control, audit and inspection; handling deviations and corrective actions)
Standard operating procedures for a clinical trial, writing of a standard operating procedure (Dr. Patrick Brunel)
MODULE 5/ January 29
th& 30
th& 31
st2015
Thursday 29
Drug development – Preclinical and clinical development
16h – 20h Workshop 1: Clinical Research applied to medical devices. From development to post marketing. (Dr. Abdelnour Faraj)
Friday 30
Research bases and methodology
16h – 20h Data analysis: Database constitution; Data transmission; Data management and analyses e.CRF, e-Core Lab.
(Dr. Jirar Topouchian)
Saturday 31
Research bases and methodology
9h - 13h Manufacturing and Distribution Risk management:
-Good Manufacturing Practices & Good Distribution Practices general principles and guidelines for medicinal products
-Our compliance to GMP and our control system as per quality standards -Interpretation of local, EU & US GMP and GDP requirements
- Bio-equivalence studies between generic products and innovators. (Dr. Marlene Akl & Dr Claude Khalil)
Pharmacology
14h – 19h Pharmaco-vigilance: organization, methods, and imputability
Role of the hospital pharmacist in clinical trials; Drug management; IVRS (central randomization) Traceability of therapeutic units (Dr. Marie -Thérèse Sawaya)
MODULE 6/ February 20
th& 21
st2015
Friday 20
Research bases and methodology :
16h –20h Terminology and different methodologies of clinical trials
Trial treatment and design: randomization, blinding, stratification… Quiz
Trial essential documents: protocol, CRF, investigator brochure, informed consent (Dr. Mirna Chahine)
Saturday 21
Statistics and data analysis
8h- 14h Data analysis and interpretation: primary and secondary endpoints, post-hoc analysis … The statistical report (Dr. Pascale Salameh)
MODULE 7/ March 27
th& 28
th2015
Friday 27
16h -20h Statistical principles for clinical trials (Dr. Nadine Yared)
Saturday 28
Research bases and methodology
9h00 – 11h00 Regulatory requirements of national and international agencies and administrative commissions: FDA, EMEA, Good Clinical Practice and Good Research Practice principles, « International Conference on Harmonization » (ICH) Dr. Luc Feldman & Dr. Catherine Dubanchet
11h00 – 13h00 « CoreLab ». Adjucation; « Data monitoring Committee »; The organization of Research: Budget and Organization; Confidentiality (NDA). The various types of medical research: Experimental, biological and molecular research; Clinical and epidemiological research; new research prospects: industrial and non industrial (Dr. Luc Feldman & Dr. Catherine Dubanchet)
14h – 18h Studies in human, the various phases of clinical trials: phases II, III & IV, post-marketing studies, morbi-mortality studies.
Workshop: Conceiving a clinical development plan and phase I to III clinical protocols The major steps: duration, cost, commercialization, patents and brands
(Dr Arnaud Lucien)
MODULE 9/ April 17
th& 18
th2015
Friday 17
Introduction to bibliographic handling and to medical writing
16h00- 19h00 Elaboration of a grant proposal. Dr. Mirna Chahine
Saturday 18
Drug development – Preclinical and clinical development
9h – 13h Workshop 2: Clinical Research applied to medical devices. From development to post marketing. (Dr. Abdelnour Faraj)
14h30 -17h Applied Research in the evaluation of health care systems: evaluation of needs, selection and implementation of supply (Dr. Walid Ammar)
17h- 19h Workshop on performing a clinical study (Dr. Roland Asmar)
MODULE 11/ 22
nd& 23
thMay 2015
Friday 22
Research bases and methodology
16h00- 19h30 Oral Communication: Tools and Methods (Dr. Soulaima Chamat)
Saturday 23
Research bases and methodology
9h – 12h Tips for a good oral presentation (Dr. Mirna Chahine) Introduction to bibliographic handling and to medical writing
13h30 – 17h30 Effective literature search techniques using free reliable medical Internet resources. (Mrs Aida Farha)
MODULE 12/ 5
th& 6
thJune 2015
Friday 5
Research bases and methodology
16h -20h Workshop: Oral Communication: Tools and Methods (Dr. Soulaima Chamat)
Saturday 6
Research bases and methodology : role of the CRAs and CRTs 9h- 13h Contribution to the elaboration of study protocols
Study implementation, pre-investigation visit (Dr. Tabassome Simon et Dr Ziad Mallat)
14h30– 17h Control of the quality and the reliability of the collected study data
Data quality assurance: Quality control and audit; Management and follow-up of the study visits (Dr. Tabassome Simon et Dr Ziad Mallat)
THE PROFESSIONAL TRAINING
A 2-week min active training session will be organized for all students having successfully achieved written tests; this training is optional for persons already working in research units.
This active training phase will take place in laboratory research units, contract research organizations (CRO), academic hospital centers, or in clinical investigation centers (CIC). Training sessions will be carried out in Lebanon first, then in other countries, depending on the availability of positions and the student’s grade at the final exam.
A training agreement will settle and fix the training modalities and relationships between the student, the university and the laboratory where the training will take place.
