Clinical Research- Advance (Audio+Test+Certificate)




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



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