Module I: Fundamentals of Clinical Research
This module will help you master the core fundamentals of clinical research starting with the background and history of clinical research. Then, you will learn the relevance of the fields of pathophysiology and pharmacology in clinical research. Later, you will focus on the process of drug development and its mechanisms before learning the different trial phases. Finally you will learn the distinction between Intellectual Property Rights and Patents that form the DNA of clinical research and you will learn their importance.

Contents of Module I

	The Pharmaceutical Industry and Clinical Research:    An Overview
	Introduction to Clinical Research
	Clinical Research Terminologies
	CRO's and Clinical Research Careers
	Patho-physiology, Pharmacology-Relevance to   Clinical Research
	Introduction to Drug Development
	New Drug Discovery
	Drug Formulation
	Pre-clinical Drug Development
	Approval Processes (IND, NDA, ANDA)
	Clinical Trial Design
	Bio-pharmaceutics, Bioavailability
	Clinical Development of Drug
	Intellectual Property Rights (IPR) and Patents

Module II: Guidelines in Clinical Research
This Module focuses on the ethical guidelines detailed in the Good Clinical Practice (GCP), Declaration of Helsinki, Belmont Report, Nuremburg Code, etc that form the base of the clinical research pyramid. A good understanding of the principles of GCP is mandatory for handling clinical trials. Further, you will learn the regulations governing clinical research and particularly gain inputs on DCGI, Schedule Y which set the regulations regulating clinical trials in India.

Contents of Module II

	Ethics in Clinical Research
	World Medical Association Declaration of Helsinki
	Ethics Committee-IRB/IEC
	Brainstorming ICH-GCP
	Clinical Research Regulation in India – Drugs   Controller General of India (DCGI)
	Schedule Y
	Regulatory Bodies in USA, Europe and Australia
	Special Concerns
	Protocol
	Investigator Brochure
	Informed Consent Process
	Record Keeping and Data Handling
	HIPAA in Clinical Research

Module III: Clinical Research Verticals
This module will give you an in-depth view of the different verticals in clinical research, ranging from Clinical Research Coordinator (CRC) to a Medical writer and Biostatistician etc.

Clinical trials are conducted in an increasingly complex and regulated environment. Hence, a robust understanding of the roles and responsibilities of different verticals in clinical research industry would give you an advantage of handling similar trials/situation in any complex setting.

As a clinical research professional, you must be able to work effectively with investigator, sponsor and clinical research co-coordinators to accomplish key objectives of the trials.

Contents of Module III

	Sponsor and CRO
	Investigator
	Site Selection and Recruitment of Subjects
	Clinical Research Coordinator
	Clinical Research Associate / Monitor
	Clinical Data Management
	Pharmacovigilance
	Introduction to Medical Writing
	Statistical Analysis and Clinical Trials
	Quality Assurance

Module IV: Clinical Research Management
This module helps you understand the management aspects of clinical research including the important decisions to be taken during the conduct of a clinical trial, the pitfalls to avoid and the importance of quality management in clinical research. It will also explain the processes to undertake in order to successfully conduct and complete a clinical trial.

Contents of Module IV

	How to Manage Clinical Trials
	Pitfalls in Clinical Research -- How to Avoid  Them.
	Clinical Research - Decision Making Tools
	Quality Management in Clinical Research
	Prescription for the Success in Clinical Research

Module V: Professional Development and Career Skills
The knowledge and skills you gain from this module will make you a better professional. The clinical research employers are on a constant look out for candidates with this professional edge.

Contents of Module

	Career Skills
		Taking Charge of Your Career
		Preparing a Winning Resume/CV
		Interview Cracking Skills
		Starting a New job
	Professional Development Skills
		Professional Development and Planning
		Effective Communication Skills
		Time Management
		Tools for Decision Making
		Problem Solving
		Introduction to Six Sigma
		Action Learning
		Leadership Development

What Next?

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