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Clinical Research

Clinical Research

Master the complete lifecycle of clinical research — from new drug discovery and preclinical studies through Phase 0–IV clinical trials, regulatory submissions, GCP principles, ethical frameworks, study design, and key trial roles. This foundation program by IIHCM equips pharmacy, nursing, and medical students with the knowledge and terminology to launch a confident career in clinical research.

₹5000

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Has discount
Expiry period 1 Months
Made in English
Last updated at Tue Jun 2026
Level
Advanced
Total lectures 1
Total quizzes 0
Total duration 0 Hours
Total enrolment 0
Number of reviews 0
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Short description Master the complete lifecycle of clinical research — from new drug discovery and preclinical studies through Phase 0–IV clinical trials, regulatory submissions, GCP principles, ethical frameworks, study design, and key trial roles. This foundation program by IIHCM equips pharmacy, nursing, and medical students with the knowledge and terminology to launch a confident career in clinical research.
Outcomes
  • ✓ Explain the complete new drug discovery and development process from preclinical to post-marketing surveillance
  • ✓ Distinguish between Phase 0, I, II, III, and IV clinical trials and describe the purpose and typical sample size of each phase
  • ✓ Interpret and prepare regulatory dossiers including INDA/IMPD, NDA/MAA, ANDA, and BLA using CTD module structure
  • ✓ Apply ICH E6 GCP principles and identify the responsibilities of Sponsors, Investigators, CRAs, CRCs, and IRB/IEC members
  • ✓ Evaluate clinical trial study designs including RCTs (parallel and crossover), observational designs, and decentralized trial models
  • ✓ Describe ethical frameworks — Nuremberg Code, Declaration of Helsinki, Belmont Report, CIOMS, and the Common Rule — and apply them to trial scenarios
  • ✓ Understand blinding techniques (single, double, triple-blind), allocation concealment, dummy techniques, placebo use, and sources of bias
  • ✓ Correctly use and explain 60+ essential clinical research terminologies used in the pharmaceutical and CRO industry
  • ✓ Describe the components and purpose of Trial Master Files (TMF/eTMF), Informed Consent Forms (ICF), and Case Report Forms (CRF)
  • ✓ Apply epidemiological concepts — incidence, prevalence, epidemic, endemic, and pandemic — to understand public health and clinical research context
  • ✓ Demonstrate readiness for entry-level roles in clinical research, regulatory affairs, pharmacovigilance, and the pharmaceutical industry
Requirements
  • Academic eligibility: Students enrolled in or graduates of B.Pharm, M.Pharm, or Pharm.D programs B.Sc Nursing, M.Sc Nursing, or Post Basic Nursing students and graduates MBBS, MD, BDS, or allied health science students Life sciences graduates (Biochemistry, Biotechnology, Microbiology, Zoology) Healthcare professionals seeking a formal clinical research foundation
  • Prerequisites & technical needs: Basic understanding of human anatomy, physiology, and pharmacology Proficiency in English (reading and comprehension level) No prior clinical research experience required — beginner-friendly Device with PDF/presentation viewer (laptop, tablet, or desktop recommended) Willingness to engage with regulatory documents, guidelines, and scientific terminology

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