Welcome to GCP on-line!
|
This ICH GCP course will give you a current and comprehensive guide to the principles of Good Clinical Practice. In 1997, the Food and Drug Administration (FDA) endorsed the Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonization (ICH). GCP is an international standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
This online training solution is a perfect choice for healthcare professionals who are new to clinical trials. The course could also provide a timely update for the experienced clinical research MDs and nurses.
|
|
OnlineGCP has continuously worked towards satisfying and supporting a wide spectrum of requirements for ICH-GCP training. Our course is packed with documents, glossary, links, case studies and useful tips. It covers all international ICH-GCP guidelines and US regulations (21 CFR).
The course has been expertly written by Dr. Laura Brown, currently the Course Director, MSc Clinical Research, Cardiff University, UK. She has 20 years of experience in pharma industry, pharma training and extensive academic background (PhD, MBA, BSc Biochemistry, BSc Psychology, Post-graduate Diploma in Clinical Sciences).
She has also authored and co-authored of 8 books in total, including Learning and Development (2003).
|
|
|
|
Certification
|
|
If you score more than 80% on the GCP exam, we will issue you with a certificate for your records and, if you agree, your name and organisation details will be added to a database of GCP certified personnel that have passed this course. This database can be publicly accessed.
|
|
|
|
|
|
|
Topics of the GCP course:
|
|
The topics presented in the online GCP training cover all the different aspects
of the Good Clinical Practice. Please press the button below to review the training
freely.
|
|
|
Introduction
|
|
|
|
The Principles of ICH GCP
|
|
|
|
Informed Consent
|
|
|
|
Ethics - Institutional Review Boards
|
|
|
|
Responsibilities of the Investigator
|
|
|
|
Responsibilities of the Sponsor
|
|
|
|
Clinical Trial Protocol
|
|
|
|
Investigator Brochure
|
|
|
|
Essential Documents
|
|
|
|
Who should take the course?
|
|
|
|
As prescribed by the international standards and requirements, a basic understanding of Good Clinical Practice is prerequisite for anyone carrying out, or involved in, clinical research and clinical trials. The course is therefore relevant to:
|
|
|
|
Investigators from hospitals, pharmaceutical companies, and research institutes
|
|
Clinical trials support staff (e.g staff working in contract research organisations)
|
|
Research Nurses
|
|
R&D staff involved in approving and monitoring clinical trials
|
|
Members of Institutional Review Boards
|
|
Graduates looking to develop a career in clinical research
|
|
|
|
|
| News |
|
|
Why aren’t medical devices tested like drugs?
28/01/2014
|
Earlier this week, the BBC Radio Four programme “Face the Facts” highlighted the scandalous state of the medical device sector. Their report centred on some women who had experienced extreme adverse reaction to trans-vaginal mesh implants. The programme went on to complain about the lack of the highly controlled and blinded testing regime undergone by drugs.
|
more
|
|
|
|
|
|
|
|
|
|
|
|
