Overview

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.

Skills

Reviews