Course Outline
Module 00 : Life Sciences Industry & Regulations for Clinical Research
Module 01 : Introduction to Clinical Research
Module 02 : Basic Principles of Clinical Pharmacology and Drug Action
Module 03 : Clinical Trial Protocol & Amendments
Module 04 : Informed Consent (ICD)
Module 05 : Clinical Trial Masterfile
Module 06 : Role of a Contract Research Organization (CRO) / Site Management & Monitoring in Clinical Research
Module 07 : Ethical Guidelines for Clinical Research
Module 08 : Safety Definitions and Adverse Event reporting requirements
Module 09 : Clinical Trials Monitoring at site
Module 10 : Project Management in Clinical Trials
Module 11 : Information Technology tools, AI in Clinical Trial Management
Module 12 : Safety and Hygiene at Clinical Trial site and workplace
Module 13 : Soft Skills & Business Writing
