🇬🇧 Interactive Training in Applied GCP for Investigators, Researchers & Clinical Staff

• Clinical and Epidemiological Investigation Center (CIEC)

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.

Important information

• A GCP certificate will be delivered upon participation & passing the final test (Otherwise certificate of attendance)
• A GCP certificate is mandatory for all person working within studies including human subjects and is valid for a period of 2 years.

Agenda

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

Trainer

Information: tania.zamboni@lih.lu