Good Clinical Practice (GCP) Training for Investigators and Study Teams

Overview

This compact two-day Good Clinical Practice course is designed in accordance with the requirements of Swissethics and covers the Good Clinical Practice knowledge indispensable for Investigators of clinical trials. 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 Ethics Committee submission in Switzerland. It is ideal for Investigators, study personnel and people involved and/or interested in clinical research. The course is suited for beginners as well as experienced investigators in need of refresher training. 

The course is accredited by Swissethics (since 2016) and listed at TransCelerate (since 2017).

The participants benefit from the extensive experience of our teachers. All teachers can draw on many years of hands-on clinical operations in Switzerland as well as in countries with limited resources.

Course Content

The training covers the key principles of the ICH-GCP E6(R2) and ICH-GCP E8(R1) guideline. The draft version of GCP E6(R3) which currently is in public consultation will be introduced and considered. We provide a historical overview of the development of international guidelines in clinical research and of the role of ethics committees. The duties of investigators are presented in detail, those of study sponsors touched on. In addition, the phases of drug development, the principles of data management and study documentation of safety reporting and the submission of projects to Ethics Committees in Switzerland, are explained. The importance of and the organization of quality management are demonstrated.

Course Structure

The course consists of presentations, enriched with practical examples, supplemented with interactive exercises and case studies. Prior to the course, participants will be expected to have read the the "Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects" (Version October 2013, Fortaleza) and the "ICH Guideline E8(R1) general considerations for clinical studies", and have browsed the "ICH Guideline E6(R2) for Good Clinical Practice" (appr. 3-4 hours).

At a Glance

Evaluation and Certification

The course is accredited by Swissethics and fulfills the training requirements for Investigators, Sub-Investigators and members of study teams. After the course, participants will need to pass an online competency assessment (multiple choice consisting of 20 questions)

A 'Certificate of Attendance" will be provided if the following conditions are met:

  •           if both entire course days were attended
  •           if the online test was passed with at least 70 % correct answers

 

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 (HFG/HRA, VKlin/ClinO, KlinV-Mep/ ClinO-MD, HFV/HRO)
  • 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 know the investigator’s role and responsibilities in a clinical study,
  • 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 records 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

 

Costs

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.

 

Cancellation Conditions:

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.

Registration

Good Clinical Practice (GCP) Training for Investigators and Study Teams, 14 - 15 March 2023

Venue: Swiss TPH (Kreuzstrasse 2, 4123 Allschwil (BL), Switzerland)

REGISTRATION closed

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Good Clinical Practice (GCP) Training for Investigators and Study Teams, 15 - 16 August 2023

Venue: Swiss TPH (Kreuzstrasse 2, 4123 Allschwil (BL), Switzerland)

REGISTRATION closed

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Good Clinical Practice (GCP) Training for Investigators and Study Teams, 5 – 6 December 2023

Venue: Swiss TPH (Kreuzstrasse 2, 4123 Allschwil (BL), Switzerland)

REGISTRATION