Learn Advanced Clinical Research Fundamentals From Scratch

Role of Clinical Research Coordinator, Clinical Research Associate, New Drug Discovery & Development

What you'll learn

Understand the role of Clinical research and its scope, New Drug Discovery & Development

Historical background of Clinical Research

Role & Responsibilities of Clinical Research Coordinator, Clinical Research Associate, Sponsor, Ethics Committee in detail

Learn various Essential documents in the conduct of Clinical trials such as Case report form, Protocol, Investigator's brochure, Informed Consent form, etc

Requirements

UG/PG in Life sciences, Chemistry, UG/PG in Medicine, Dental and/or Nursing, UG/PG in Pharmacy

Description

After pursuing this course Learners will understand what is Clinical Research, Its scope, Various domains and careers in Clinical research.Learners will get insights into the various historical events that led to the development of various Codes, Guidelines, Declarations in the field of Clinical Research. Various Essential documents for the conduct of Clinical trial like Protocol, Investigator's Brochure, Case report form, Informed consent form, etc.This course also highlights the importance of Clinical data management, Medical writing, Clinical operations, etc .There is a topic of New Drug Discovery & Development which explains the process of Drug discovery and the development of a Drug such as Pre-clinical research, Clinical research & Post-marketing surveillance studies.There are 2 topics on Pharmacology explaining Pharmacokinetics and Pharmacodynamics in detail.Pharmacokinetics means the movement of Drug in and out of the body i.e. Absorption, Distribution, Metabolism & Elimination of drug.Pharmacodynamics means what a drug does to the body i.e. the response which it creates.There is also a topic on Audits & Inspections.Audits are performed by a Sponsor and/or Contract Research organization at a clinical trial site. Inspections are performed by Regulatory authorities i.e. Governmental bodies in any country where  clinical research is conducted.

Overview

Section 1: Introduction

Lecture 1 Terminologies in Clinical Research

Lecture 2 Historical background of clinical research

Lecture 3 New Drug Discovery & Development

Lecture 4 Role & Responsibilities of a Clinical Research Coordinator

Lecture 5 Role & Responsibilities of a Clinical Research Associate

Lecture 6 Role and Responsibilities of IRB/IEC

Lecture 7 Designing of a Case report form

Lecture 8 Clinical Data Management in Clinical trials

Lecture 9 Protocol & Amendments

Lecture 10 Informed Consent Process

Lecture 11 Investigator's Brochure

Lecture 12 Medical Writing

Lecture 13 Role of Sponsor in Clinical Trials

Lecture 14 Role of Contract Research Organization (CRO) in Clinical trials

Lecture 15 ICH-GCP guidelines

Lecture 16 Essential documents in the conduct of a Clinical Trial

Lecture 17 Clinical Research Designs

Lecture 18 Audits & Inspections in Clinical Research

Lecture 19 Core Principles of Good Clinical Practice

Lecture 20 Introduction to Pharmacology-I

Lecture 21 An Introduction to Pharmacology-II

UG/PG in various life science disciplines who are keen to pursue career in Clinical Research