Course Curriculum

Clinical trial protocol & protocol amendment
Clinical trial investigator brochure
Informed consent
Subject recruitment & retention
Regulations in clinical trials(FDA/EMEA/DCGI/TGA)
HIPAA ( health insurance for portability & accountability act)
Responsibilities of sponsor , investigator & monitor
Safety & adverse reactions in clinical trials
Introduction to Clinical Data Management
Data – definition , forms & database design
CRF design
CRF printing & vendor selection
Data entry & processing
Handling of external data
Data validation
SAE Reconciliation
Discrepancy management
Assuring data quality
Database closure
Reading Raw Data
Basic Concept
Reading SAS Datasets
Combining Datasets
Components of SAS
Data acquisition & storage
Data base validation
PDP & Soft skills training
Job Interview Preparation
Mock Interview
HANDS – ON TRAINING as applicable PROJECT WORK (Clinical Study) As applicable

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