PG Diploma in Clinical Data Management(Part Time)

Course Curriculum

* Clinical Trial Process
* Good Clinical Practice & other regulatory guidelines
* Protocol & CRF designing
* Clinical Data Management
o Data capture methods
o Data Entry
o External Data Loading
o Data Validation
o Query Management
o Data Storage & archival
* Quality Systems, SOP'S & Audits
* Regulations & guidelines for CDM
* Safety Data Management
* Statistical Analysis & Reporting
* Data Management Systems & Tools
* Documentation & Document Management System
* Medical coding and medical dictionaries


Practical

* Clinical Data Management System
o Study Set-Up
o GLIBS
o Data Entry
o Data Validations
o Query Management
o Database lock
o Validation procedures