Clinical Research Online Expert level by Medgalaxy Academy of Clinical Research

Clinical Research is the branch of pharmaceutical industry which deals with step by step study of any new drug in human volunteers to evaluate its safety, efficacy and tolerability profile. Clinical Data Management is responsible for review of data collected for accuracy, medical coding and performs SAE review and reconciliation.
Pharmacovigilance (also called Drug Safety Monitoring) team is responsible for adverse event data collection, processing, causality assessment and reporting. The different career options include but not limited to Clinical Data Manager, Drug Safety Scientist, Clinical Research Associate, Clinical Research Coordinator, Medical Reviewer/ Medical Monitors.

Introduction to Clinical Research

Drug Development Process

ICH-GCP Guidelines

Ethical Guidelines and IRB/IEC

Informed Consent Form/ Process

Important Job Roles and Responsibilities

Investigators Brochure

Protocol

Study Designs and Randomization

SAE Review and Reconciliation

Introduction to Pharmacovigilance (History and Overview)

Regulatory bodies (Domestic and International)

Adverse Events

Sources and Types of Adverse Event Reports

Regulatory Reporting Guidelines and Timelines

Case Assessment and Processing

Triage and Medical Review

Medical Coding

PSUR and ICSR

Introduction to Oracle ARGUS-Safety database

Case Processing

Case Narrative writing

Interview Preparation and Practice session