Certification Course In Clinical Research, Cdm & Pv

Clinical Research, Phase trials, Good Clinical Practices, Ethics Committee, Pharmacovigilance, Clinical Data Management

What you'll learn

Introduction to Clinical Research

Careers in Clinical Research, Data Management & Pharmacovigilance

Drug Development, Phase trials & Regulatory Submissions

Good Clinical Practices & 13 Principles of ICH GCP

Fundamentals of Clinical Data Management

Drug Safety & Pharmacovigilance

Stakeholders in Clinical Research

Role of Human Subject in Clinical Trials & Inform Consent Process

Monitoring in Clinical Trials

Roles & Responsibilities of Sponsor, Investigator, Site team in Clincial Trials

Ethics Committee and Role in Subject Safety Protection

Roles & Responsibilities of Clinical Research Coordinator, Clinical Trial Assistant & Clinical Research Associate

Clinical Trial Design

Blinding, Unblinding, Placebo & Randomization in Clinical trials

Regulatory Submissions, Rules & Regulations

Essential Documents in Clinical Research

Terminologies for Adverse Events (AE), Adverse Drug Reactions (ADR) & Serious Adverse Events (SAE) & timelines

Requirements

No prerequisite is needed for this course.

Description

This is the ideal course for you if you find are curious about Drug Development Process and want to explore & seek a career in Clinical Research. In order to safeguard the public's health, the pharmaceutical industry is subject to numerous government restrictions, making it one of the most heavily regulated sectors. Marketing a Drug/Medicinal product that satisfies regulatory criteria is a key goal for the pharmaceutical sector which is achieved through conducting Clinical Trials. Clinical research is medical research that studies people to understand health and disease. Clinical research helps improve the way doctors treat and prevent illness. Through clinical research, researchers learn about important as aspects of the medicine such as How the Drug Works in the human? How illness develops in people, such as how diseases get better or worse over time? How the body handles a possible treatment & cures of the disease, Which behaviors help people stay healthy and prevent illness, and which behaviors raise the chance of illness The goal is to use science to improve people’s health care and health over time. The participants who join and take part in clinical research studies may or may not get any benefit for themselves.You will gain a solid understanding of the drug development process, clinical research and related documentation, GCP, and the roles and duties of key clinical research players in a condensed form from this course.Topics covered in this course are:- Introduction to Clinical Research- History of Clinical Research- Declaration of Helsinki- Nuremberg Code & Medical Ethics- Good Clinical Practices (GCP)- 13 Principles of ICG GCP- ICH, Contents & it's Importance.- Glossary terms- Stake Holders in Clinical Research- Roles & Responsibilities of PI- Roles & Responsibilities of Sponsor- Roles and Responsibilities of EC- Roles and Responsibilities of Contract Research Organization- Roles & Responsibilities of CRA, CRC- Role of Subject in Clinical Trials & Inform Consent process- Role of RA, Biostatistician & Clinical Data Manger in trials- Monitoring in Clinical Trials- Clinical Trial Design- Essential Documents in Clinical Trials- Careers & Opportunities in Clinical Research- Skill Development & Seeking various Careers in Clinical Research- Investigator's Brochure & Protocol- Clinical Trial overview

Overview

Section 1: Introduction

Lecture 1 Introduction

Section 2: History of Clinical Research

Lecture 2 History of Clinical Research

Section 3: Drug Development & Phases of Clinical Trials

Lecture 3 Drug Development & Phases of Clinical Trials

Section 4: ICH GCP, Good Clinical Practices & 13 principles of GCP

Lecture 4 ICH GCP, Good Clinical Practices & 13 principles of GCP

Section 5: Stakeholders in Clinical Research & Ethics Committee

Lecture 5 Stakeholders in Clinical Research & Ethics Committee

Section 6: Clinical Trial Design

Lecture 6 Designing Clinical Trials

Section 7: Human Participation & Informed Consent in Clinical Trials

Lecture 7 Human Participation & Informed Consent in Clinical Trials

Section 8: Clinical Data Management

Lecture 8 Clinical Data Management in Clinical Research

Section 9: Drug Safety & Pharmacovigilance

Lecture 9 Drug Safety & Pharmacovigilance

Section 10: Careers in Clinical Research

Lecture 10 Careers & Opportunities in Clinical Research

Section 11: Course Summary

Lecture 11 Course Summary & Skills acquired in the certification

Students & Professionals exploring Career opportunities in Clinical Research,Science graduates curios about Drug development & Clinical Trials,Anyone curious about understanding Phase trials & Regulatory requirements