Clinical Research- Advance (Audio+Test+Certificate)
Clinical Trial Regulatory Bodies, Clinical Trial Designs, Essential Documents
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What You Will 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
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 Pharmacy
2. Graduate or postgraduate degree in Medicine or any healthcare stream
3. Graduate or postgraduate degree in Life Sciences
4. Anyone from a related healthcare industry
What This Course Covers?
Module 1: Importance & Types of Clinical Trials
Module 2: Clinical Trial Phases & Key Players at Glance
Module 3: ICH GCP Principles
Module 4: Essential Documents
o Protocol
o Informed Consent Document (ICD)
o Case Report Form (CRF)
o Investigators Brochure (IB)
Module 5: Clinical Trial Regulatory Bodies
o US-FDA
o MHRA
o EMA
o PMDA
o CDSCO
Module 6: Audit & Inspection
Module 7: Special Population Clinical Trials
o Geriatric
o Paediatric
o Special & Vulnerable Population etc.
Module 8: Clinical Trial Designs
Module 9: Case Studies
Module 10: Clinical Trial Terminologies
Who Should Attend!
- 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