CDM Training in and Universities

HULBRON Gérard Co-writer POITIERS University CASSANAS Genevieve, professor DMB Board Member MONTPELLIER University DMB team leader (training group) DMB Board Member

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The 2 main sites in are located in MONTPELLIER and POITIERS

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CDM training in universities

POITIERS MONTPELLIER University University

Two diplomas:

Bachelor in Sciences Master ECV Master In Sciences GPHY

Partnership with DMB association

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People in charge of education in clinical trials at POITIERS

Pr. Patrick GIRARD for IT

Pr. Jean-Michel MAIXENT for CT

Associate Pr. Gérard HULBRON for CDM

Bât. Mécanique, 40, av du Recteur Pineau 86022 POITIERS Cédex http://www-gphy.univ-poitiers.fr Tél : (33) (0)5 49 45 37 24

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CDM training in universities

Person in charge of education group in clinical trials at MONTPELLIER

Genevieve CASSANAS, professor University Montpellier1 Ingénierie de la Santé - Master Biologie Santé Faculté de Pharmacie- BP 14 491 15 Avenue Charles Flahault - 34093 MONTPELLIER CEDEX 1- FRANCE e-mail : [email protected]

http://www.is-iup.univ-montp1.fr

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History of POITIERS

MASTERS

 Created in 1973 (Bac+5)  Specific course which combines computer systems and Biology  Then in 2002 starts the CDM option

BACHELORS

 2004-2005 : First year of Bachelor (Bac+3)

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CDM training in universities

History of POITIERS

Number of students per year

 Master : approximately 10 students in the option CDM

 Bachelor : between 15 and 20 students

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History of MONTPELLIER

 Created in 1991 (IUP Ingénierie de la Santé, bac + 4)  DESS Clinical Data Management (bac+5) created in 1998, transformed in Master Ingénierie de la Santé in 2003

 Students have a background of CRA or Project Management

 The course done during the last year (Bac +5) is almost oriented in Clinical Data Management (for CDM option)

 Approximately 20 students for masters 1 (bac + 4 - ARC training)  Approximately 10-15 students for masters 2 (bac + 5 - CDM option)

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CDM training in universities

Bachelor : What was the purpose of this level

 First it was created linked with the new organisation of diploma in France (Bac + 3, 5, 8)

 The idea also was to offer a level of education intermediate in the panel of jobs included in the Clinical Data Management.

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Training (pharmaceutical companies or CRO’s)

 Masters  3 months (at bac+4)  6 months (at bac+5)

 Bachelor (in alternation)  Now during the education all students are employed by a company  At the beginning of the year they stay alternatively one month in the company and one month in the university  At the end of the year they stay 3 months in the company

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CDM training in

What are the different options POITIERS University

BACHELOR

CLINICAL TRIALS IS VALIDATION

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What are the different options POITIERS University

MASTERS

LIMS CLINICAL TRIALS Laboratory BIOTECHNOLOGY MEDICAL IMAGING informatics systems

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CDM training in POITIERS

General Training for Bachelor

Company Physiology Principle and Design and knowledge and Programming method of programming and Core course therapeutics Development clinical trials of data base Communicati class and Validation on Methods

Data Data Management Management Data Statistical environment : software Clinical trials Training in Management tools (SAS) Protocol, CRF, Clintrial and project Company option CDISC, Capture Alternate Coding System one month in company

Laboratory and Systems and tools and LIMS : Set uo university LIMS Methods Project LIMS functioning - and carry out option Validation Quality

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General Training for Masters (Year 1)

Pre-clinical development, data Conception and Biostatistics Physiopathology management Object oriented initiation Programming

Genomics Advanced database and Cancer Biology and Pharmacology and applications Bio Informatics Tools physiological consequences

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CDM training in POITIERS

General Training for Masters (Year 2)

Database Methodology of Informatics systems in administration and Data Management clinical trials biology (GED) Business Intelligence

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What are the different options MONTPELLIER University

MASTER INGENIERIE DE LA SANTE

CLINICAL PROJECT OPERATIONS MANAGEMENT CLINICAL PHARMACEUTICAL OF HEALTH INVESTIGATIONS BIOTECHNOLOGY DATA PRODUCTS MANAGEMENT

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CDM training in MONTPELLIER General Training for Masters (Year 1) option Clinical R&D : CRA formation All these modules must be validated

Quality management, Pharmaceutical Pre-clinical Clinical Development Pharmaceutical Regulatory development Data base Biotehnologies Affairs

Biometry: Clinical monitoring Logistics of Biostatistics Good Clinical Practice Therapeutics Axis Clinical trials Quality Control data management Submissions process initiation

Training in company or CRO: five months (from 1st april to 30th august)

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General Training for Masters (Year 2) option Clinical R&D : Data Management All these modules must be validated

Project management Quality Management SQL, PL/SQL OperationalProject management planning Quality Management programmingSQL, PL/SQL Data Management : Clinical trials: Operational planning Strategic and programming clinical trials, protocol, CRF, Financial Analysis OperationalStrategic Marketing and SAS programming protocol, CRF design Annotated CRF, operational Marketing SAS programming Financial Analysis CDISC

Project of the Projectstudents of the Data Managementstudents of Project of the Data Management 1: a clinical trial from a Project of the Data Management 2: Data Management of students Dataclinical Management trials, 1: protocol and a CRF on Data validation plan, a clinical trial from a students protocol,data base CRF, set-up, data Data Management 2: Clintrial system programming, protocol and a CRF labbase data set-up, loading, Data validation plan, the students work Dictionaries, programming,Queries, the students work lab data loading, “base“base set-up, set-up on in project team, data coding DiscrepanciesQueries, data coding dataClintrial validation system, plan, usingin project operational team , Discrepancies programming,data validation plan, using operational Using Clintrial planning (GANTT) queries....programming, planning (GANTT) toqueries.... database locked to database lock

Training in company or CRO : six months (from 1st april to 30th september) 19

CDM training in universities

Spécific Training in Data Management

 Design of protocol and CRF  Annotated CRF  Data base setup  Data entry  Data validation plan  Programming in SQL  Data validation  Queries  Coding  Data base frozen  SAS export

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Training tool in Data Management at the university

Clintrial™ Clinical Data Management System With the help of Phase ForwardStudents create a true database during the course

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CDM training in universities

www.clinsight.fr

Capture System

SAS

Oracle Clinical at Montpellier

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Possibility of employment

 All students at the end have an employment 3 months maximum after having validated their exam which is part of my motivation

 Students have a job mainly in the pharmaceutical industry, hospitals and CROs

 However as they have a huge education in database and programming they get many jobs in this area

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CDM training in universities

Possibility of employment

 In the recent year particulary for Bachelor as they have a training on the software Capture Sytem they are employed in data management services in hospital

 The reason is that this software is more convenient for a restricted team in data management which is the case in hospital

 Sometimes some students get a job in statistics but it is not our first goal

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General comments on course organisation

 One major reason of the success is that an important amount of the teachers are coming from the industry

 We try to be very practical in our education

 The difficulty however is to find people from the industry which can free time to come to the university

 We try to bring students also having a great autonomy

 These diplomas in France have the certification of the University

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CDM training in universities

Finally

All we have done for the differents training in Clinical Data Management in France will not have been possible without the participation of the members of DMB association

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