Clinical investigation (perhaps with newly discovered drugs) involving human subjects is a precarious activity and could lead to ethical dilemmas. Therefore, laws and regulations apply to ensure good clinical practice. As an investigator in a clinical trial, you need to know about the relevant national and international laws and regulations. What’s more, it’s important to know which parties are involved in clinical trials and what their responsibilities are. Directives for good clinical practice are recorded in the ICH-GCP Guideline.
ICH-GCP: a guideline for good clinical practice
ICH-GCP is the international ethical and scientific quality standard on how clinical trials should be set up, conducted and reported. It furthermore defines the responsibilities and tasks of people with key roles – such as investigators, sponsors and ethics committees (IRB/IEC) – and identifies documents essential for clinical trials. This online medical course explains the context of the ICH-GCP Guideline and is comprehensively structured to follow the various phases of a clinical trial: preparation, execution and close-out.
By the end of this course, you will understand the general development process of a drug, the framework of international laws and regulations governing clinical trials, and the applicability, purpose and key aspects of ICH-GCP. Also, you will be able to identify the key parties in a clinical trial and understand their requirements, responsibilities and tasks throughout the three phases of a clinical trial.
This course is suitable for medical professionals intending to be involved in a clinical trial in which a drug will be tested on human subjects. The focus will be on the responsibilities involved in clinical trials from a drug investigation perspective, rather than focusing on the scientific research itself.
This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of Good Clinical Practice training among trial sponsors.
The Good Clinical Practice course is also available in the Dutch language (Good Clinical Practice (GCP) and WMO in de eerstelijn). This course is developed in close cooperation with our clinical research partner institute Julius Clinical and specifically aimed at Dutch General Practitioners and professionals working in Primary Care setting.
The Dutch course is offered free of charge to all members of the Julius Clinical Primary Care Research Network (PCRN). For non-members the course fee is €115. To learn more about PCRN and to become a member, please visit the website or call + 31 (0)30 6569955. For direct enrollment in the course (without membership), please click here. Please note: Payment via Creditcard or Ideal will enable you to start our online medical courses immediately. Payment via invoice may take a few processing days.
By the end of the Good Clinical Practice course, you will be able to: