Clinical trials occur in four phases.
Phase I
Safety assessment
Phase II
Dose and efficacy evaluation
Phase III
Large-scale comparison studies
Phase IV
Post-marketing surveillance
Module 1: Introduction to Clinical Research & CDM
▪ Introduction to Healthcare & Pharma Industry
▪ Overview of Clinical Research Ecosystem
▪ Drug Development Lifecycle
▪ Clinical Trial Phases (I–IV)
▪ Introduction to Clinical Data Management
▪ Role of CDM in Clinical Trials
▪ Importance of Data Quality in Clinical Research
▪ Clinical Research Stakeholders
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