PCCRCDM (Professional Certificate In Clinical Research And Clinical Data Management)
Course Content:
Clinical Trial Process
Clinical Trial Design
Ethics & Good Clinical Practice
Clinical Data Management
CRF Design
Data Entry
Data Collection
Data Load
Data Storage
Data Validation
Query Management
Data Archiving
Quality Systems, Sops & Audits
Regulatory Affairs & Compliance
Safety Management and Pharmacovigilance
Statistical Analysis & Reporting
Data Management Systems & Tools
CDMS
AERS
EDC
Analytical Tools
Documentation & Document Management System
Medical coding and medical dictionaries
Project Management
Security systems
Practical:
Clinical Data Management System
Study Set-Up
Database Creation
CRF Creation
Data Entry
Data Validations
Query Management
Database lock
Statistical Software
