You are a professional within clinical research; investigator, monitor or other staff; then you need to comply with the Good Clinical Practice guideline. This one-day course will give you the needed ICH-GCP training, required by the majority of European Regulators.
Our ICH-GCP training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by “TransCelerate BioPharma” as necessary to enable mutual recognition of GCP training among trial sponsors.
Without training on the International Council for Harmonisation Good Clinical Practice (ICH-GCP) standards, or without experience in clinical research, professionals are not always aware of the legal regulations that govern clinical studies, including post-marketing trials. ICH-GCP is the guideline ruling all clinical research including its conduct, performance, monitoring and reporting of the results. This course focuses on the requirements of Good Clinical Practice (GCP) in clinical studies with pharmaceuticals. The complete and most recent version of the ICH-GCP is covered by this training, including the Addendum of 2016. All elements of the addendum, such as risk-based quality management and supervision will be presented. In addition, implementation of GCP requirements is explained and illustrated using examples from practice.
Furthermore, our ICH-GCP training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training Identified by TransCelerate BioPharma, as requested for mutual recognition of GCP training among trial sponsors.
The course will allow professionals who are active in clinical research to fully understand the requirements and responsibilities of everyone involved in clinical research.
Course time09h00 - 17h00
Who should attend
Everyone who wants to understand the current Good Clinical Practice (GCP) requirements for clinical studies. No prior training or working experience in a GCP environment is required.
- Clinical Research and Regulations
- ICH-GCP definitions and Principles
- ICH-GCP Responsibilities of Ethics Committees/ Investigators/Sponsors/Monitors
- The Protocol, Investigator’s Brochure and other Essential Trial Documents
- The GCP-Addendum of 2016
- Common GCP non-compliance
- Fully grasp the GCP requirements for conduct and documentation of clinical studies
- Distinguish the responsibilities of all involved parties
- Understand the regulatory requirements imposed by GCP
- Recognise common problems and obtain insight to avoid errors
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (3)
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) (8)
- Study and Site Management (2)
- Data Management and Informatics (5)
- Leadership and Professionalism (1)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained.