Global Certified Sub-Investigator GCP Programme - ICH E6(R3)
Published 9/2026
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz, 2 Ch
Language: English | Duration: 5h 28m | Size: 3.34 GB

TransCelerate & FPM Compliant Design · 23.5 CPD Hours - Applications to Follow

What you'll learn
GCP & Regulatory Framework
Sub-Investigator Role & Boundaries
ICH E6(R3) 42 Principles Application
Core Operational Responsibilities
Documentation, Inspection & Professional Practice

Requirements
You do NOT need prior GCP knowledge, certificates, or experience to START this course. It is designed to take you from foundational knowledge to full operational competence.

Description

Disclosure:"This course contains the use of artificial intelligence."

The ONLY GCP course built specifically for Sub-Investigators - fully aligned with ICH E6(R3) and TransCelerate Mutual Recognition Standards. One certificate accepted by 60+ major pharmaceutical sponsors worldwide.

What Makes This Course Different?
Most GCP courses are written for Principal Investigators or Study Coordinators - too much high-level legal responsibility you don't need, and not enough practical guidance on exactly what YOU do every day. This programme is builtexclusively for Sub-Investigators - covering every task you perform, every boundary you must respect, and every rule you must follow under ICH E6(R3), thecurrent mandatory global standard.

What You Will Learn
-ICH E6(R3) Global Framework - GCP purpose, history, and mandatory adoption timelines

-All 42 Principles of ICH GCP - explained simply with your daily responsibilities highlighted

-Investigator Responsibilities - what YOU can do, what ONLY the PI can do, delegation rules

-Data Governance & ALCOA+ - source data, documentation, corrections, and audit trails

-Sub-Investigator Daily Practice - workflow, eligibility, visits, deviations, and close-out

-Safety Reporting Masterclass - AE → SAE → SUSAR classification, causality, and 24-hour rules

-Investigational Product Management - storage, accountability, temperature checks, reconciliation

-Informed Consent - step-by-step conversation, vulnerable groups, re-consent triggers

-Inspection Survival Guide - what inspectors ask, how to answer, and CAPA responses

-Professional Practice - contracts, indemnity, protected time, and 2-year recertification

Unique Learning Format - Every Module Includes
Clear Learning Objectives

Key Points Video

Full Comprehensive Reading

Audio Summary

Visual Infographic

Questions, Quizzes,Assignments ,etc

CertificationPass all module quizzes +60-Question Final Assessment (≥80%)→ receive yourofficial certificate

Global RecognitionNote: This training certification satisfies the GCP training requirement. Formal appointment as a Sub-Investigator also requires a valid professional licence and designation by the Principal Investigator on a Delegation Log.

Who this course is for
This course is specifically designed for healthcare professionals and site staff who serve - or intend to serve - as Sub-Investigators on clinical trials. It fills a unique gap: GCP training tailored exactly to your role, rather than generic Principal Investigator or coordinator training.

Homepage

https://www.udemy.com/course/global-certified-sub-investigator-gcp-programme-ich-e6r3/