TitreIntroduction au Data Management
Date(s)
24.03.2010
Formation subsidiée
Durée1 jour(s)
LieuSeneffe
OpérateurKeyrus (C. Scoupe)
Capacité12
Public cibleBasic knowledge of the ICH-GCP guidelines
Description
Objective :

This training is intended for people working in Data Management and for non-data managers working within the pharmaceutical and health environment who whish to learn about the key data Management concepts.
 
 
Program :
  
Introduction
- Data Management Process within the Clinical & the reporting Process
 
Data Management Process (Paper data Entry)
- CRF design
- CRF annotation
- DB design
- Checks definition
- DB testing
- Data Entry
- Queries generation
- Data Corrections
- Data Uploads
- Database lock
 
Data Management Process (electronic CRF)
- Adapted CDM and operational Process for e-CRF
- Data management role
- Monitors and Investigator’s role
 
Requirements & Standards
- 21CFR part 11
- E-records
- Good Documentation Practices
- CDISC
- E-Submission

Method : It combines presentation and in-depth discussions relating to clinical data 
management activities.
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