Good Clinical Practice (GCP) Training: Detailed Information
Course Learning Objectives
The goals for participants of this course are:
To 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 (HMG, VKlin)
To understand the different phases of drug development
To gain an understanding of the role of ethics committees, in particular their mandate to protect the patient’s well-being, integrity and autonomy
To define the investigator’s role and responsibilities in a clinical study, particularly with regard to informed consent and safety reporting
To learn about the submission process to ethics committees and regulatory authorities
To 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
To become acquainted with the essential study documents and to understand the importance of proper document management
To understand the different study designs of clinical trials, the prevention of bias and the basic principles of statistics as well as protocol optimization
To adopt Good Documentation Practices
To understand the principles of data capture (e.g. CRF), data quality and data management
To learn about the definition and consequences of research misconduct
The following topics are covered in the course:
Introduction to Good Clinical Practice, historical background and research ethics
Key principles of the ICH GCP E6 (R2) Guideline and investigator responsibilities
Legal and regulatory requirements of clinical research, with a focus on Switzerland
Role of ethics committees, regulatory authorities and submission processes
Basic statistical concepts and study design, including protocol optimization
Study documentation and data management including case report form design
The Good Clinical Practice (GCP) course aims to provide professionals with the information, methods and tools needed to implement clinical research according to international standards.
Medical, nursing and scientific staff involved in clinical trials, students as well as individuals who support clinical research activities, such as laboratory personnel, IT and finance professionals.
Evaluation and Certification
The course is accredited by Swissethics and fufills the training requirements for Investigators and Sub-Investigators.
After the course, participants will need to pass a competency assessment (multiple choice consisting of 20 questions), with a minimum passing score of 70%, in order to receive a certificate of training. This certificate will be e-mailed to participants after they have successfully completed the competency assessment.
Course fee for external participants: CHF 950
Course fee for Basel University / University Hospital Basel employees: CHF 700
Course fee for Swiss TPH employees: CHF 300
The fee includes training documentation, refreshments, coffee breaks, snack/buffet lunch
The course fee is due upon receipt of the invoice. It is possible to cancel the attendance two weeks prior to the event for an administrative fee of CHF 50.00. For cancellations up to one week prior to the event, 50 % of the attendance fee will be charged; for less than one week the whole attendance fee must be paid.