Parcours MODM – gestion données cliniques-english

Clinical Operations Management and Data Management
Speciality clinical databases management

Information : Myrtille Vivien

SPECIALIZED TRAINING OFFICERS IN THE DATA MANAGEMENT OF CLINICAL STUDIES
With dual skills in Project Management / Quality.

  • Design, implementation and monitoring of clinical trials, pharmacovigilance,
  • Quality in business, business planning and project management, team management,
  • Management Control, Marketing,
  • SAS programming, SQL, PL / SQL,
  • Regulations, ICH GCP.
  • Protocol, basic design, CRF, quality control,
    validation plan, consistency tests, coding and dictionaries, laboratory data base gel …,
  • Realization of Data Management of real clinical database, under the direction of an industrial project team and in total autonomy, creation from
    the protocol and case report forms on the study until frost of the database.

TEACHERS

  • Teachers – Researchers at the University of Montpellier,
  • Data Management professionals from the pharmaceutical industry (SANOFI, SERVIER Laboratories, SANOFI-PASTEUR), CRO (Altizem, Quintiles, Amitis, QuanticSoft, Lincoln) and academic structures (ICM CPI).

PROFESSIONAL EXPERIENCE IN THE PHARMACEUTICAL INDUSTRY

INTERNSHIP 5 MONTHS IN 1 + 1 MASTER / STAGE 6 MONTHS IN MASTER 2

PROFESSIONAL OPPORTUNITIES
The Master’s businesses are in the clinical research sector in CRO, pharmaceutical,
academic structures, as well as in the food industry or veterinary as manager (basic) biomedical data (Data Manager).

Regularly updated clinical research and data management websites :

scdm

Society for Clinical Data Management

ASDMB

Association Française de Data Management Biomédical

cercle

Cercle Languedoc-Roussillon

Groupe des Data Manager Académiques

Groupe des Data Managers Académiques

CLINICAL OPERATIONS MANAGEMENT AND DATA MANAGEMENT
CLINICAL DATABASES MANAGEMENT

play_GDC

SKILLS ASSESSMENT GUIDELINES :

GOALS, CONTENTS AND TEACHERS FOR ALL TEACHING UNITS IN THIS COURSE : :

MASTER 1 – prog 2015-2016

SEMESTER 1

COMMON CORE(S1)

TU 101 : REGULATORY AND FINANCIAL ASPECTS – QUALITY AND SAFETY

Goals:

Pharmaceutical law:

  • To know the various texts applying to the field of medicines, their origin, their legal value, their articulation
  • To have some knowledge of the various health products
  • To know the basics of innovation protection control, manufacturing, marketing and monitoring of medicines

Quality :

  • To know the quality demands and management tools

Security :

  • To know the regulations of ICPE classified installations
  • To know the classification and labelling of chemical products’ hazards

Marketing :

  • To integrate the marketing’s global approach
  • To know the diagnostic tools and the strategic directions

Financial analysis

  • To be able to analyse the profitability, the solvency and the liquidity of an economic activity (industrial company)

Content:

  • Pharmaceutical law (18hrs-Lecture)
  • Financial analysis (12hrs-Lecture)
  • Marketing (6hrs-Lecture)
  • Quality (10hrs-Lecture)
  • Safety (6hrs-Lecture)

Teachers:

  • V. RAGE-ANDRIEU
  • C. LE GAL
  • R. BARTHES
  • N. DELELIGNE
  • A. ESCANDE
  • V. BOISSERIE LAPORTE
  • O. VEYRET
  • A. GARD

TU 102: DATABASES – EPIDEMIOLOGY AND ENVIRONNEMENTAL HEALTH

Goals:

To comprehend epidemiological studies:

  • To identify epidemiology as public health tools
  • To know the epidemiological surveillance tools
  • To know the different types of epidemiological surveys
  • To be able to interpret descriptive epidemiology indicators
  • To be able to calculate and interpret the results of risk calculation (RR and OR) from analytical epidemiology
  • To be able to describe and criticise the strategies and protocols of studies implemented in epidemiology
  • To be able to assess the validity of screening tests
  • To know the behaviour and the impact of organic pollutants present in the environnement and to understand the related legislation

Databases:

  • To discover the basics of databases management
  • To understand how the information is structured thanks to the relational model
  • To recognise the different database usage patterns (administrator/client)
  • To be able to build a database including a few tables
  • To be able to define the main confines on a database
  • To be abe to use the main commands of the SQL language
  • To be autonomous on the data management system ACCESS (Microsoft)

Content:

  • Database (4hrs-Lecture+ 15hrs-Tutorial)
  • Epidemiology (12hrs-Lecture)
  • Environmental health (18hrs-Lecture)

Teachers:

  • M. VIVIEN
  • P. RAVEL
  • H. FENET
  • A. ESCANDE
  • F. COURANT
  • C. CASELLAS
  • E. GOMEZ

TU 103: HEALTH PRODUCTS DEVELOPMENT STRATEGY– PROJECT MANAGEMENT AND CLINICAL DEVELOPMENT

Goals:

  • General knowledge of the sectors of medicines, cosmetology and medical devices
  • Knowledge of the regulatory and socio-economic specificities of the medicines, cosmetology and medical devices
  • Initiation to the project management of health products development
  • Initiation to the proceedings of clinical trials in accordance with the Good Clinical Practices (GCP)

Content:

  • Development strategy: Medicines (12hrs-Lecture), Cosmetology (6hrs-Lecture) and Medical Devices (6hrs-Lectures)
  • Regulations in Europe, Japan and the United-States (6hrs-Lecture)
  • Clinical development (9hrs-Lecture)
  • Project management (6hrs-Lecture + 3hrs-Tutorial)

Teachers:

Montpellier University

  • B. BATAILLE
  • S. BEGU
  • J. COUDANE
  • X. GARRIC
  • A. EL GHAZOUI
  • P. CREMADES
  • W. AGOUMI

TU 104: BIOTECHNOLOGIES APPLIED TO HEALTH

Goals:

  • To know the various health products produced by biotechnologies
  • To acquire the notions of therapeutic targets and biomarkers
  • To acquire the notions of medium and high throughput screening
  • To know the technologies of recombinant DNA (GMO notion) and protein engineering
  • To know the production and quality control processes
  • To have a concrete overview of the conditions of production of a recombinant protein and of the development of a cellular model that is compatible with medium throughput screening (practical works carried out)

Content:

  • Identification of the molecular or cellular targets and of the biomarkers (8hrs-Lecture)
  • Production/Quality control (3hrs-Lecture)
  • Industrial applications/examples (11hrs-Lecture)
  • Virtual cloning (6hrs-Tutorial)
  • Production, purification, characterisation of a recombinant protein (12hrs-Practical work)
  • Preparation of a cellular model for medium throughput screening– visit of a high throughput pharmacological screening platform (10hrs-Practical work)

Teachers:

Montpellier University

  • S. CHAUMONT
  • A. CHOQUET
  • F. COURANT
  • S. DELBECQ
  • A-D. LAJOIX
  • X. GARRIC
  • S. MARY
  • F. MACARI-FINE
  • M.A. POUL

External professionals

  • ARPEGE Platform, IGF Montpellier

TU 105: FOREIGN LANGUAGES AND COMMUNICATION

Goals:

  • To develop communication skills in foreign languages
  • Specialized vocabulary
  • Knowledge of the companies and health matters in the countries of the target language
  • Cultural approach

Content:

  • Foreign languages (40hrs-Tutorial)
  • Communication (9hrs-Tutorial)

Teachers:

Montpellier University

  • I. MAITRE-DEVALLON
  • Y. ZAMBRANO
  • G. NICKSON
  • P. WEINMANN

Teachers extérieurs

  • Communication consultancy

SPECIFIC TU: CLINICAL OPERATIONS MANAGEMENT AND DATA MANAGEMENT (S1)

TU 107: THERAPEUTIC APPROACHES – PHARMACOKINETIC – PEC

Goals:

  • To acquire the basic knowledge related to the different therapeutic approaches which are subject to clinical studies (clinical research professions)
  • To understand the pharmacokinetic file
  • To be able to introduce oneself orally and in writing

Content:

Therapeutic approaches

  • Cancerology, Cardiovascular disorders, SNC, Pneumology, Thrombosis, Diabetes, High blood pressure, Haematology, Rheumatology, Psychiatry, Analgesics, Malaria, Infectiology, Vaccine trials, Medical devices trials

Pharmacokinetics

  • Definition of the main variables included in Phase 1 of the clinical development’s proceedings

Teachers:

Montpellier University

  • B. BAÑULS
  • S. KHIER
  • G. CROS
  • P. DRAKULOVSKI
  • S. HANSEL
  • M. MAILLIE

External professionals

  • Médecins hospitaliers et cliniques
  • Professional speakers

SEMESTER 2

COMMON CORE(S2)

TU 201: ENGLISH AND SECOND LANGUAGE

Goals:

  • To develop communication skills in a foreign language
  • Specialised vocabulary
  • Knowledge of the companies and health matters in the countries of the target language
  • Cultural approach

Content: 40hrs

  • Work on all communication skills: written and oral expression and comprehension
  • Knowledge of the professional and cultural international environment
  • Job interview simulation, oral presentation using PowerPoint, meetings simulation, writing letters and emails, debates, documents reading etc.
  • Methodological aspects (according to the groups’ needs)
  • Practice on digital platform aiming at revising and strengthening language skills

Teachers:

  • I. MAITRE-DEVALLON
  • Y. ZAMBRANO
  • G. NICKSON
  • P. WEINMANN

TU 202: 3 to 5 MONTH WORK PLACEMENT

Goals:

  • To put into practice the skills gained during the training course
  • To achieve a concrete professional project within one’s context of activities

Content:

  • Preparation and instruction to find and complete a work placement (3hrs-Lecture)
  • 3 to 5 months full-time in a public or private company

Teachers:

  • B. BAÑULS
  • B. BATAILLE
  • S. BEGU
  • A. EL GHZAOUI
  • P. RAVEL
  • M. VIVIEN
  • A. ESCANDE
  • E. GOMEZ
  • B. NOTTELET
  • X. GARRIC

SPECIFIC TU: CLINICAL OPERATIONS MANAGEMENT AND DATA MANAGEMENT (S2)

TU 209 : CLINICAL TRIALS MONITORING AND LOGISTICS

Goals:

  • To acquire the basic knowledge related to clinical trials implementation (profession of Clinical research associate)
  • Good Clinical Practices
  • The profession of Clinical research associate (CRA)

Content:

Clinical trials Monitoring and Logistics:

  • Trial implementation, protocol, case report forms, e-FIU
  • Monitoring visits follow-up from the first visit to the closing
  • Investigators: recruitment and training, brochures
  • Essential documents for conducting trials (before, during and end of trial)
  • Documents for submission to HAS (ANSM, CPP, CNIL…)
  • Distribution of clinical batches

Clinical research key players and professions :

  • The profession of laboratory CRA / hospital CRA
  • The structures involved in clinical research (CIC, URC, CRC, CRB..)

Clinical trials in Phase I, II, III

Bioequivalence tests

Epidemiological studies

Preparation to work placements

Hospital work placement (4 weeks)

Teachers:

Montpellier University

  • B. BAÑULS
  • V. BOISSERIE LAPORTE (PAST)

External professionals

  • Pharmaceutical industry professionals, of CRO and UHC

TU 210: REGULATORY AFFAIRS, PCBS, PHARMACOVIGILANCE

Goals:

  • To acquire the basic knowledge in the regulatory environment (profession of Clinical Research and Development)
  • To master the Good Clinical Practices – standardisation ICH, CTD, FDA, EMEA, AFFSAPS, …
  • Drug monitoring, adverse effects

Content:

  • Quality assurance and quality control in clinical research and audits
  • Regulatory environment Europe, US, Japan
  • Protocol implementation
  • Good Clinical Practices – standardisation ICH, CTD, FDA, EMEA, AFFSAPS …
  • Drug monitoring, adverse effects

Teachers:

Montpellier University

  • V. BOISSERIE LAPORTE (PAST)

External Professionals

  • Pharmaceutical industry professionals, of CRO and UHC

TU 211: INTRODUCTION TO CLINICAL DATABASES MANAGEMENT – DATA MANAGEMENT

Goals:

  • Introduction to DATA management
  • To know the different clinical data entry methods
  • To give the students who wish to pursue a career in the CRA professions the basic knowledge related to clinical databases management: to be able to create a database from a FIU, to know the main controls
  • To understand the main statistical analysis associated to clinical trials

Content:

DATA Management:

  • The profession of data manager
  • The context of data management

Introduction to the SAS language:

  • Creating tables
  • Importing data files
  • Using simple procedures for the description of statistical data
  • Using some statistical procedures

Statistical methodology applied to clinical research:

  • Stastistics reminder
  • Experimental plans: parallel plans, matched series plans, ‘cross over’ plans, Bioequivalence tests

Medical writing

Teachers:

Montpellier University

  • P. Ravel
  • M. Vivien
  • R. Sabatier

External professionals

  • Effi-Stat and ESISMP school
MASTER 2 – prog 2016-2017

SEMESTER 3

COMMON CORE(S3)

TU 301: HEALTH PRODUCTS PROJECT MANAGEMENT, MANAGEMENT CONTROL AND PERFORMANCE MANAGEMENT

Goals:

Project management:

  • To understand the concepts, processes and project management methods within the frame described by the Project Management Institute
  • Operational planning: from analysing a project to the preparation of a feasible work schedule
  • To know the basic framework of innovation protection, manufacturing, the marketing and surveillance of medicines

Management control:

  • To assess and understand through an account of company’s results, the items of profitality and performance

MS Project:

  • To be able to use the MS Project software

Content:

  • Project management (12hrs- Lecture + 12hrs-Tutorial)
  • Management control and performance management (6hrs-Lecture + 6hrs-Tutorial)
  • MS Project software (12hrs-Tutorial)

Teachers:

Montpellier University

  • P. CREMADES
  • R. BARTHES

External professionals

  • Service provider

TU 302: QUALITY MANAGEMENT, MARKETING

Goals:

Team management:

  • To clarify the missions, roles and function of a team manager (project)
  • To understand the influence of one’s leadership of the team’s performance
  • To identify one’s management style, one’s negotiation style
  • To be able to lead a meeting

Quality management :

  • To master quality management

Marketing:

  • To understand the market’s mechanisms
  • To be able to identify the relevant stakeholders and to analyse the influence factors
  • To know the various strategic manoeuvres (by comparison with the demand and faced with the competition)
  • To be able to define the appropriate operational modes

Content:

  • Team management (12,5hrs-Tutorial)
  • Quality management (14hrs-Lecture + 12hrs-Tutorial)
  • Marketing (12hrs-Lecture)

Teachers:

  • R. BARTHES
  • N. DE LELIGNE
  • L. KABBARA BARDINA

SPECIFIC TU : CLINICAL OPERATIONS MANAGEMENT AND DATA MANAGEMENT(S3)

TU 311 : DATA MANAGEMENT 1

Goals:

  • To know the basics of CDISC and STDM standards
  • To know the regulations regarding patients’ data
  • To be able to design a plan for the validation of a clinical study
  • To be able to carry out the « data cleaning » stages
  • To know the basics of risks management
  • To know and understand the issues encountered during the coding of the undesirable events and concomiting treatements, and the coding dictionary

Content:

  • CDISC – SDTM
  • Data Privacy
  • Validation plan
  • Data Cleaning
  • Risks management
  • Coding undesirable events and concomitant treatments

Teachers:

  • External professionals: QuanticSoft, Effi-Stat, Laboratory of International Research Servier, Sanofi, MedDRa correspondant

TU 315 : RELATIONNAL DATABASES MANAGEMENT – SQL and PLS/SQL PROGRAMMING

Goals:

  • To be able to design the entity-relationship model of a database
  • To be able to design a relational database
  • To be able to implement it in SQL language
  • To be able to perform simple and complex SQL queries
  • To be able to implement programs for Procedural Language / SQL (PL / SQL)
  • To be able to use the SQL and PL/SQL languages in with Oracle ®
  • To Understand the management of concurrent accesses in Oracle ®

Content:

  • The Model Entity / Association, the relational model, the Algebraic language
  • The SQL language: the data definition language, the creation language, the query language
  • Oracle transactions, concurrent accesses management
  • The PL/SQL language: cursors, triggers

Teachers:

Montpellier University

  • M. VIVIEN

TU 316 : LANGUAGE SAS – STATISTICS

Goals:

  • To import data from different sources
  • To collect and format data from different tables
  • To produce listings
  • To produce graphics
  • To analyze data by conventional statistical methods

Content:

  • Language and syntax in SAS
  • Statistics reminders
  • SAS Language practice
  • Lincoln Company Training
  • basic SAS and SAS macro language
  • Listings
  • Graphics
  • Statistics with SAS

Teachers:

Montpellier University

  • C. REYNES

External Professionals

  • Société Lincoln

TU 317 : DATA MANAGEMENT 2

Goals:

  • To know how to design a clinical database from a CRF based regarding the protocol
  • To understand the Issues of the clinical Data Manager and what happens to the data afterwards
  • To know the Good Clinical Data Management Practices
  • To code adverse events and concomitant medications using coding dictionaries and a professional software
  • To write a data transfer protocol for the attention of a central laboratory
  • To import external data and export data from a professional software

Content:

  • From the CRF to the database
  • Passage of the Data Management to the Statisticians
  • Good Clinical Practices of the Data Management
  • Coding of adverse events and concomitant medication in practice
  • Exporting data and Importing laboratory data with a professional software

Teachers:

External Professionals

  • Sanofi, Effi-Stat, correspondant MedDra, Amitis

TU 318 : TOOLS AND TECHNIQUES FOR DATA MANAGEMENT – LEARNING BY PROJECT 1ST PART

Goals:

  • To be able to write a Data Validation Plan
  • To be able to manage outsourcing in Clinical Data Management
  • To be able to manage outsourcing from the CRO point of view
  • To be able to use a professional software to design a clinical database
  • To know the different kind of data entries
  • To know the specificities of Data Management in academic structures
  • To master the methods and project management tools, operational planning, time and team management

Content:

  • Performing a data validation plan from the example database used in all the lessons
  • Outsourcing in clinical data management, Data Management in academic structure
  • Training to design and data entry using a professional software
  • Learning by project Part I: design of the clinical database from an real protocol and real CRF, using a professional software, in project team, under the direction of a pharmaceutical company.

Teachers:

External Professionals

  • Laboratoire de Recherches Internationales Servier, Sanofi- Pasteur, Quintiles, Altizem, Institut Paoli-Calmette (IPC) , Institut Régional du Cancer de Montpellier (ICM)

SEMESTER 4

COMMON CORE- STAGE (S4)

TU 401: 4 TO 6 MONTH WORK PLACEMENT

Goals:

  • To carry out a concrete professional project within its context of activities

Content:

  • 2hrs Lecture: preparation and instructions to find and do a work placement
  • 4 to 6 months full-time in a public or private company

Teachers:

  • B. BAÑULS
  • B. BATAILLE
  • S. BEGU
  • A. EL GHZAOUI
  • P. RAVEL
  • M. VIVIEN
  • E. GOMEZ
  • X. GARRIC

SPECIFIC TU: CLINICAL OPERATIONS MANAGEMENT AND DATA MANAGEMENT (S4)

TU 409: VALIDATION – QUALITY CONTROL – GEL BASE

Goals:

  • To program edit checks in the SAS language and the language of the Professional software used
  • To unterstand the step of SAE reconciliation
  • To master Quality Control Processes in Data Management
  • To know the regulatory environment of Data Management
  • To Know how to manage the database lock stages of a clinical trial

Content:20h-CM + 33h-TP

  • Programming validation checks in two different languages
  • Quality control, Blind Review, SAE Reconciliation, regulatory environment of clinical Data Management, database lock

Teachers:

External Professionals

  • Servier Laboratory, ESISMP

TU 410 :APP PART 2

Goals:

  • To master the tools and techniques of project management, business planning, quality management and team management
  • To create a data validation plan from a real protocol and a real CRF
  • To know how to program the validation rules described in the data validation plan in the languages of the professional software used
  • To write data entry guidelines
  • To know how to write data clarification forms
  • To realize SAE and concomitant medications coding
  • To know how to write a data transfer protocol, to import laboratory data, using a professional software
  • To organize a blind review meeting
  • To organize the database lock

Content:

  • Realization of all monitoring stages of Data Management, in team project, of the clinical trial whose the database was created in the TU 318 by performing all required quality control processes and documentations:
    – Data Validation Plan
    – Data entry of the CRF
    – Programming of data validation rules
    – Resolution of data clarification forms
    – Coding of adverse events and medical terms
    – Importing laboratory data
    – Database lock

Teachers:

  • Pharmaceutical Laboratory, Sanofi, Servier, …