Free Download Learn Advanced Clinical Research Fundamentals From Scratch
Published 12/2023
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz
Language: English | Size: 6.60 GB | Duration: 9h 1m
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
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