This compact two-day Good Clinical Practice course is designed in accordance with the requirements of Swissethics and covers the Good Clinical Practice knowledge essential for investigators of clinical trials and their teams.

The course consists of a comprehensive overview of ICH-GCP with a focus on the GCP principles, participant protection, informed consent and safety reporting, as well as topics such as study design, data management and submission to ethics committees in Switzerland. The course is ideal for investigators, study personnel and people involved in and/or interested in clinical research. The course is suitable for beginners as well as experienced investigators who need a refresher or need to acquire a certificate.

The course has been accredited by Swissethics since 2016 and listed with TransCelerate since 2017. Participants benefit from the extensive experience of our teachers. All teachers have many years of hands-on clinical operations, both in Switzerland and in resource-limited countries.

The objectives for the participants of this course are as follows:

• Understand the historical development, the principles and content of international guidelines for clinical research (Declaration of Helsinki, ICH-GCP) and their influence on the Swiss legislation (HFG/HRA, VKlin/ClinO, KlinV-Mep/ ClinO-MD, HFV/HRO)
• Understand the different phases of drug development
• Gain an understanding of the role of ethics committees, in particular their mandate to protect the well-being, integrity and autonomy of patients
• Understand the role and responsibilities of the investigator in a clinical study
• Understand the submission process to ethics committees and regulatory authorities
• Understand the principles of quality assurance and quality control and their implementation in clinical studies, including the importance of standard operating procedures, study monitoring and audits
• Become familiar with the essential study records and to understand the importance of proper document management
• Understand the different study designs of clinical trials, the prevention of bias and the basic principles of statistics and protocol optimisation
• Adopt good documentation practices
• Understand the principles of data capture (e.g. CRF), data quality and data management
• Be familiar with the definition and the consequences of research misconduct

Find more information here.