DIPLOMA IN CLINICAL RESEARCH AND CLINICAL DATA MANAGEMENT

Course Curriculum of Diploma in Clinical Research and CDM

Module.1- General Introduction to Clinical Research

Module.2 – Clinical Pharmacology

Module.3- Drug Discovery, Development & Phases of Clinical Trial

Module.4- Credentials of Clinical Trial

Module.5- CT Activities – Before, During & After

Module.6- Roles & Responsibilities of Clinical Research Professional

Module.7- Need of Ethics in Clinical Research

Module.8- Overview to Regulatory Affairs

Module.9- Overview to Medical Writing

Module.10- Overview to Pharmacovigiliance

Module 11 - Introduction to Data Management & Workflow

Module 12 - Stakeholders & their Responsibilities

Module 13 - Data Management Plan

Module 14 - CRF Design Considerations

Module 15 – CDM – Data Processes, Data Review/Data Validation & Discrepancies Management

Module 16 - SAE Review & Reconciliation

Module 17 - Medical Coding

Module 18 - Database Closure & QC

Module 19 - CDM- Documents & Guidelines