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

15/03/2021 13:00 to 15/03/2021 19:00 (Europe/Luxembourg)

Performance of clinical trials according to Good Clinical Practice (GCP) principles has been introduced as a European regulatory requirement by the Clinical Trial Directive 2001/20/EC. Strict adherence to this standard ensures patient protection and reliable data. It is the basis for acceptance of publications and for patients’ access to new treatments. This standard has implications for all stakeholders and processes in clinical trials. However, despite overall commitment and best intentions to apply to these requirements, monitoring, audits and inspections regularly find deficiencies of different levels of severity.

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.

In this interactive workshop current experience and requirements of GCP-conform set-up and performance of clinical trials will be presented, their practical implications and examples discussed and pragmatic solutions for your daily practice elaborated.

This online training will be held in English.

Important note:

Certificate is valid for 2 years. It must therefore be renewed to comply with good clinical practices.


13:00 Welcome and introduction

13:10 | Good Clinical (Research) Practice in European              Legislation

14:10 | Question & Answers

14:20 | Break

14:35 Set up of a clinical trial at the investigative site

15:00 | Discussion

15:10 | Optimizing the inform consent process

15:35 | Discussion

15:40 | Break

15:50 | GCP compliance in document management

16:25 | Discussion

16:30 | Break

16:45 | Critical elements of conducting clinical trials

17:30 | Discussion

17:35 | Break

17:45 | Reliable safety management at the site

18:00 | Final Test

19:00 | End of the training



Odoo - Sample 2 for three columns

Ingrid Klingmann


 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)

Language: English


When: 15th March 2021

Time: 1:00 p.m. – 7:00 p.m.



As the number of seats is limited, we will accept registrations on a first come first served basis.


1st price 
Students / UNI / LCSB
National hospitals national health care professionals researchers / PI national academia
​€ 0
2nd price
​International academia€ 100
3rd price
​Industry / private companies€ 200

Organized by: 

Clinical and Epidemiological Investigation Center

 in collaboration with:



From 15/03/2021 13:00
To 15/03/2021 19:00


Luxembourg Institute of Health
+352 26 970
+352 26 970 719