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International ICH-GCP Online Training and Certification

If you are looking for pure ICH-GCP training online, this course will present you with an accessible, comprehensive, and flexible way of achieving a GCP certificate, which is endorsed by the Royal Holloway, University of London. The course covers all the changes/amendments proposed in the EU Directive 2005/28/EC. In addition, the Summary of Proposed Changes to current regulations is attached for ready reference and those changes are also included in all relevant chapters of the course. A printable .pdf version of the course material is included.

Introduction & The Principles of ICH GCP

Informed Consent

Ethics

Responsibilities of Investigator

Responsibilities of Sponsor

Clinical Trial Protocol

Investigator Brochure

Essential Documents

US ICH-GCP Online Training and Certification

The US version of the GCP online training is in line both with ICH-GCP standards and regulations, as well as FDA regulations relating to them. This solution is suitable to both young and experienced clinical professionals involved in clinical trials in the United States, such as investigators, CRA’s, monitors, ethics committee members, research nurses, and university students. Accessible, comprehensive, and flexible, it gives the opportunity to avoid more costly and time-consuming alternatives to obtaining an ICH-GCP certificate. A printable .pdf version of the course material is included.

The Principles of ICH GCP

Informed Consent

Ethics

Responsibilities of Investigator

Responsibilities of Sponsor

Clinical Trial Protocol

Investigator Brochure

Essential Documents

German ICH-GCP Training and Certification

The German version of the GCP Online course provides an updated and detailed overview of the principles of Good Clinical Practice according to ICH-GCP and presents the national requirements in Germany, which are included in the German Medicines Law and the German GCP Guideline. The training was customized for the German audience by one of the most recognized names in the industry - Dr. Gerhard Fortwengel (professor at the University in Hannover) . It is perfectly suitable for every professional involved in clinical trials in Germany and covers all the requirements of the inspectional institutions. The German online GCP training is the quickest and most convenient way to obtain a recognized GCP certification and gain the GCP knowledge required for professional practice in the field of Clinical Research for our current and future German speaking customers.

Einleitung und Grundsatze der ICH GCP

The Principles of ICH GCP

Einverstandniserklarung

Ethik

Zustandigkeiten des Forschers

Zustandigkeiten des Auftraggebers

Bericht von den klinischen Studien

Broschure des Forschers

Wichtigste Unterlagen

Spanish ICH-GCP Training and Certification

This Spanish-language version of the International ICH-GCP online training is designed to facilitate Spanish-speaking clinical research professionals from Europe, Central and South America. Like the English original, it presents an accessible, comprehensive, and flexible means to achieving a GCP certificate. It is endorsed by the Royal Holloway, University of London and covers all the changes/amendments proposed in the EU Directive 2005/28/EC. In addition, the Summary of Proposed Changes to current regulations is attached for ready reference and those changes are also included in all relevant chapters of the course. A printable .pdf version of the course material is included.

Introduccion y principios de ICH GCP

Consentimiento informado

Etica

Responsabilidades del Investigador

Responsabilidades del Promotor

Protocolo del ensayo clinico

Folleto del Investigador

Documentacion relevante

Polish ICH-GCP Training and Certification

This Polish-language version of the International ICH-GCP online training is designed with Polish-speaking clinical research professionals in mind. Like the English original, it presents an accessible, comprehensive, and flexible means to achieving a GCP certificate. It is endorsed by the Royal Holloway, University of London and covers all the changes/amendments proposed in the EU Directive 2005/28/EC. In addition, the Summary of Proposed Changes to current regulations is attached for ready reference and those changes are also included in all relevant chapters of the course. A printable .pdf version of the course material is included.

Wstep i zasady ICH GCP

Zgoda poinformowana

Åtyka

Odpowiedzialnosc badacza

Odpowiedzialnosc zleceniodawcy

Sprawozdawczosc badan klinicznych

Broszura badacza

Najwazniejsze dokumenty

Italian ICH-GCP Training and Certification

This Italian-language version of the International ICH-GCP online training is intended for clinical research professionals from Italy. Like the English original, it presents an accessible, comprehensive, and flexible means to achieving a GCP certificate. It is endorsed by the Royal Holloway, University of London and covers all the changes/amendments proposed in the EU Directive 2005/28/EC. In addition, the Summary of Proposed Changes to current regulations is attached for ready reference and those changes are also included in all relevant chapters of the course. A printable .pdf version of the course material is included.

Introduzione & Principi di BPC della ICH

Consenso informato

Comitato Etico Indipendente

Responsabilita dello sperimentatore

Responsabilita dello Sponsorizzatore

Protocollo di Sperimentazione Clinica

Investigators Brochure

Documenti Essenziali

Russian ICH-GCP Training and Certification

This Russian-language version of the International ICH-GCP online training is intended for clinical research professionals from the vast Russian-speaking commonwealth. Like the English original, it presents an accessible, comprehensive, and flexible means to achieving a GCP certificate. It is endorsed by the Royal Holloway, University of London and covers all the changes/amendments proposed in the EU Directive 2005/28/EC. In addition, the Summary of Proposed Changes to current regulations is attached for ready reference and those changes are also included in all relevant chapters of the course. A printable .pdf version of the course material is included.

Введение и основные принципы проведения (ICH GCP)

Информированное согласие

Этические принципы

Обязанности исследователя

Обязанности спонсора

Протокол клинических исследований

Брошюра исследователя

Основные документы