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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