ICDM
INITIATION TO CLINICAL DATA MANAGEMENT

<Training programs

Objectives :

Raise awareness to the world, standards, processes and documentation of data management

Level of trainees :

Any person involved in clinical research (CRA, project managers,…).

Duration and location:

Duration : 7 hours over 1 day (simple format) or 14 hours over 2 days (advanced format)
Location : Soladis training center in Paris or Lyon (to consult the calendar, click on “Sign up”) or directly in your office (minimum of 4 people)

Training fee:

In Soladis office : 700€ to 990€ HT per trainee
Other : please contact us for an offer adapted to your company.

Pedagogical Manager: Sébastien LECOMTE

“This training is particularly adapted to people willing to discover the world of clinical data management, the role of the data manager and to understand in detail the activities performed by Data managers from the drafting of the first elements of studies to the delivery of a locked database. “

Training Schedule

GENERAL PRESENTATION

Role of the Data Manager in a clinical study
Guidelines and standards of the Data Manager
Data: protection, traceability, integrity…

SOFTWARE & TOOLS

Ennov Clinical software
Data hosting
Computerized system validation
SAS software
eCRF & ePRO

STUDY INITIATION & MANAGEMENT

Protocol and CRF
Study and issues management during a study
Data management steps during a study

DOCUMENTATION

Quality documents
Data Management Plan & Data Management Report
eCRF specifications
Data Validation Document

THE DATA MANAGEMENT PROCESS

Study Design
Randomization and Therapeutic Unit Management
Programming of inconsistency tests
Quality Tests and Analysis
Management of modifications during the study

LAUNCH OF AN ECRF

Go-Live of a study
Training
Sites setup
User rights Management

DATA MANAGEMENT

Coding and Pharmacovigilancy
Data Import/Export
Data Review
Database lock

STUDY ARCHIVING

Do not hesitate to contact us for more information about this training, which can be organized in our training center (dates provided on our website) or directly in your premises, according to your preferences.

Soladis - France (headquarter)
6-8 rue Bellecombe
69006 LYON - FRANCE
Tél: +33(0)4.72.83.86.70

Soladis GmbH - Switzerland
Lange Gasse 15
CH-4052 Basel
Phone: +41(0)58.258.15.80

Soladis Inc. - USA
185 Alewife Brook Pkwy, Unit 210
Cambridge, MA 02138-1100
Phone: (+1)857.675.1189