ICH GCP, Clinical research - Advanced Certification course

What you'll learn
• identify and understand the ICH-GCP requirements throughout the conduct of clinical trials
• Declaration of Helsinki guideline and principle
• Learn the core principles of ICH-GCP R3 and how to implement them in practice
• Define the roles and responsibilities of each involved key stakeholder: Ethics Committees, Sponsors and Investigators
• Understand the purpose of the essential documents and key process in clinical study
• Understand drug development and discovery, clinical trial history
• Understand the essential requirements and contents of the Investigator's Brochure and the Protocol
• Fundamentals of ICH-GCP
• Principles of ICH-GCP
• Roles & Responsibilities of IRB/IEC
• Roles & Responsibilities of Investigator
• Roles & Responsibilities of Sponsor
• Investigator's Brochure (IB)
• Clinical Trial Protocol and its Amendment
• Essential Records for the conduct of Clinical Trial
Requirements
• No prior working experience or knowledge in clinical research is required to attend this course
• This course is dedicated to beginners as wells as to more advanced professionals willing to refresh their knowledge
• Laptop / PC/ Cellphone
• Good Internet connection
• Basic English
Description
Build a Strong Foundation in Ethical & Compliant Clinical ResearchDo you want to understand how clinical trials are conducted ethically, safely, and in compliance with global regulations?This Good Clinical Practice (ICH-GCP) - Full advanced certificate Course provides a comprehensive and practical understanding of the ICH-GCP guidelines, the international standard for designing, conducting, monitoring, and reporting clinical trials involving human participants.Whether you are new to clinical research or looking to strengthen your GCP knowledge, this course will help you confidently understand regulatory expectations, participant safety, and data integrity across all phases of clinical trials.What You Will LearnCore Principles of ICH-GCPUnderstand the fundamental ethical and scientific principles that protect trial participants and ensure reliable, high-quality clinical data accepted worldwide.Roles & Responsibilities of IRB / IECLearn about the composition, functions, review processes, documentation, submissions, and communication requirements of IRB/IEC.Roles & Responsibilities of the InvestigatorGain clarity on investigator duties including protocol compliance, informed consent, participant safety, safety reporting, investigational product management, randomization, unblinding, and trial close-out.Roles & Responsibilities of the SponsorUnderstand sponsor oversight, quality management, safety assessment and reporting, investigational product handling, data and record management, non-compliance management, and clinical study reporting.Investigator's Brochure (IB)Learn the purpose, development, structure, and contents of the Investigator's Brochure, including reference safety information and risk-benefit assessment.Clinical Trial Protocol & AmendmentsUnderstand the structure and contents of a clinical trial protocol, protocol compliance, and when and how protocol amendments are implemented and approved.Essential Documents in Clinical TrialsLearn about essential records required before, during, and after a clinical trial and their importance for audits and regulatory inspections.Why Take This Course?Industry-Recognized CertificateEarn a certificate demonstrating your knowledge of ICH-GCP and clinical research compliance.Career Growth & Job ReadinessEnhance your skills for roles in clinical operations, monitoring, regulatory affairs, pharmacovigilance, and research coordination.Globally Applicable KnowledgeICH-GCP is recognized worldwide-this course prepares you for international clinical research opportunities.Beginner-Friendly & PracticalNo prior experience required. Concepts are explained clearly with real-world relevance.Who This Course Is ForClinical Research Associates (CRAs)Clinical Trial CoordinatorsInvestigators & Sub-InvestigatorsRegulatory Affairs ProfessionalsPharmacovigilance & Clinical Operations ProfessionalsStudents and anyone interested in ethical clinical research
Who this course is for
• Clinical Research Associates (CRAs)
• Clinical Trial Coordinators
• Investigators & Sub-Investigators
• Regulatory Affairs Professionals
• Pharmacovigilance & Clinical Operations Professionals
• Pharmacist, physician and Nurse
• Students and anyone interested in ethical clinical research
• Site staff, study coordinator, Data management manager, clinical research associate
• B pharmacy, M pharmacy freshers
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