Good clinical practice provides a framework of principles which aim to ensure the safety of research participants and the integrity and validity of data. This short course aims to provide the researcher with the basic principles of GCP and how these principles can be applied practically in the research setting. The course is aimed at all those involved in clinical research.
Performance of clinical trials according to the Good Clinical Practice (GCP) standard has been introduced as a European regulatory requirement for clinical trials with medicines but as this is a globally agreed best practice standard for clinical research involving human subjects, it is an ethical obligation for clinical researchers to apply this standard to all type of studies to ensure optimal protection of participants and generation of reliable results. It is the basis for enabling funding, acceptance of publications and for patients’ access to new treatments. This standard has implications for all stakeholders and processes in clinical trials.
09:00 – Welcome and Introduction
09:05 – ICH-E6(R2): Good Clinical Practice Principles and Guideline Content
10:30 – The Informed Consent Process
10:50 – Break
11:00 – Set-up of a Clinical Trial at the Site
11:30 – Compliance in Document Management
12:15 – Good Clinical Laboratory Practice
12:45 – Lunch Break
13:30 – Critical Elements in Conducting Clinical Trials
14:00 – Safety Reporting in Clinical Trials
14:15 – Multiple Choice Test
15:00 – End of the training
MD, PhD, FFPM, FBCPM
Expert in Drug Development Planning and Site Management Support, Pharmaplex bv, Brussels, Belgium & Chairman of the Board of European Forum for Good Clinical Practice (EFGCP)
Information: tania.zamboni@lih.lu
Training: 9 AM – 3 PM (test included)
C1: FREE
LIH | IBBL | Students | LCSB | National Hospitals | National Healthcare Professionals | Researchers | PI | National Academia
C2: 100 €
International academia
C3: 200 €
Private companies
Read more about the “Data Protection Notice: processing of personal data in the scope of events’ management”.