Clinical Research- Advance (Audio+Test+Certificate)

Clinical Trial Regulatory Bodies, Clinical Trial Designs, Essential Documents

What you'll learn

Importance & Types of Clinical Research

ICH GCP Principles

Essential Documents [For Example- Protocol, Informed Consent Form (ICF), Case Report Form (CRF), & Investigators Brochure (IB)]

Regulatory Authorities or Central Licensing Authorities

Audit & Inspection

Special Population Clinical Trials [For Example- Geriatric, Paediatric & Special & Vulnerable Population]

Clinical Trial Designs

Case Studies

Clinical Trial Terminologies

Clinical Research Phases & Key Players

Requirements

Graduate or postgraduate degree in Pharmacy

Graduate or postgraduate degree in Medicine or any healthcare stream

Graduate or postgraduate degree in Life Sciences

Anyone from or related to healthcare, pharma, biotech and clinical research industry

Description

The objective of the Clinical Research -advance course is to provide detailed clinical research knowledge to students, Investigators, Study Coordinators, Sponsors, Clinical Project Managers, Monitors, and any other Clinical Study staff to reach top-end positions in the clinical research Industry.This course is developed and structured in a manner considering the advance level of knowledge required in view of industry expectations. This course is integrated with practice tests in between including case study-based scenarios. In this course, you’ll learn principles and processes of clinical research, essential documents, clinical trial terminologies, understanding of the design & types of clinical trials in developing new treatments and interventions.Who Should Enroll?1. Graduate or postgraduate degree in Pharmacy2. Graduate or postgraduate degree in Medicine or any healthcare stream3. Graduate or postgraduate degree in Life Sciences4. Anyone from a related healthcare industryWhat This Course Covers?Module 1: Importance & Types of Clinical TrialsModule 2: Clinical Trial Phases & Key Players at GlanceModule 3: ICH GCP PrinciplesModule 4: Essential Documentso Protocolo Informed Consent Document (ICD)o Case Report Form (CRF)o Investigators Brochure (IB)Module 5: Clinical Trial Regulatory Bodieso US-FDAo MHRAo EMAo PMDAo CDSCOModule 6: Audit & InspectionModule 7: Special Population Clinical Trialso Geriatrico Paediatrico Special & Vulnerable Population etc.Module 8: Clinical Trial DesignsModule 9: Case StudiesModule 10: Clinical Trial Terminologies

Overview

Section 1: Foundational Elements of Clinical Research

Lecture 1 Introduction

Lecture 2 Importance & Types of Clinical Trials

Lecture 3 Clinical Trial Phases & Key Players at Glance

Lecture 4 ICH GCP Principles

Section 2: Essential Documents

Lecture 5 Essential Documents

Lecture 6 Protocol

Lecture 7 Informed Consent Document (ICD)

Lecture 8 Case Report Form (CRF)

Lecture 9 Investigators Brochure (IB)

Section 3: Clinical Trial Management and Oversight

Lecture 10 Clinical Trial Regulatory Bodies

Lecture 11 Audit & Inspection

Lecture 12 Clinical Trial Designs

Lecture 13 Special Population Clinical Trials

Lecture 14 Case Studies

Lecture 15 Clinical Trial Terminologies

Section 4: Final Examination

Suited for people interested to learn about advance clinical research,Suited for CROs, Pharma, Hospitals, Ethics Committees, Corporate Training,Suited for clinical trial professionals for refresher training,Suited for people aspiring to start career in clinical research