ICDM
INITIATION TO CLINICAL DATA MANAGEMENT

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 : 540€ to 990€ HT per trainee
  • Other : please contact us for an offer adapted to your company.
sebastien-lecomte

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.

institute.soladis-blanc

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(347).417.4008

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