Certification in Data Management

Duration: 2 months theory + 2 months onsite training

Master clinical data collection
CDISC Guidelines
- Learn EDC systems
Learn Query Listing and Edit Checks
- Ensure data integrity
- Develop analytical skills

S. No	Topic	Duration (Hours)
1	History of Clinical Research and Drug Development Process	2
2	Introduction to the Ethical and Regulatory Frameworks of Clinical Research	2
3	Fundamentals of Health Research and Evaluation Methods	6
4	Overview of ICH E6-ICH GCP	10
5	Clinical Data Management Process and Life cycle	4
6	Overview of Data Management Plan	4
8	CRF Design and CDISC Guidelines	4
9	Data Entry and Edit Checks	2
10	Data Validation and Discrepancy Management	2
11	Data Clarification Forms and Query Management	2
12	Data Coding and Medical Dictionaries	2
13	Database Locking and Freezing	2
14	Data Storage and Archival	2
15	SAE Reconciliation	2
16	Hands on Training on Electronic Data Capture	2
18	Case Studies	2