GOOD CLINICAL PRACTICE - Professional courses: How to write a clinical research protocol for a successful project

The Clinical and Epidemiological Investigation Center is organizing an advanced Good Clinical Practice Training. The training is highly recommended to all persons involved in research projects with human participants.

The protocol is the most important document of a clinical research project and the key of the success of your research project. This course will teach you how to write a protocol and will give you all the basic elements according to good Clinical Practice to write a protocol in the respect of ethical rules and participant protection. After successful completion of a test at the end of the training, the participants will obtain a certificate that will document their knowledge of GCP.

The training will be held in English.

PROGRAMME

13:00 | Welcome and introduction

13:10 | From research question to protocol
Definition of

• Regulatory elements

• Ethical elements

• Statistical and data management elements

• GCP elements

• Study medication elements

• Efficacy elements

• Safety elements

• Organisational elements

• Publication elements

15:00 | Coffee Break

15:20 | Joint Exercise

• Introduction to the research question of a real case

• Jointly defining the study condition elements

17:10 | Final multiple-choice test

17:30 | End of training