1. Good Clinical Practice for Investigator Site Teams
& Ethics Committees
version 2.00
Training Certificate F
ormali S
The Quality Experience
Registered Office:
FormaliS SA
50 Esplanade
L-9227 Diekirch
LUXEMBOURG
This document certifies that the trainee has successfully
attended and actively participated in the
“Good Clinical Practice” Training
organized by FormaliS on
Date
Venue
The trainee’s test results at the end of the course
met the minimal criteria ( >80% correct answers)
for receiving this certificate
each ticked box indicates a training session
attended by the participant
Trainee:
Name
Trainer:
Mr. Jean-Paul Eycken
CEO
FormaliS SA
This ICH E6(R2) GCP Investigator Site Training meets
the Minimum Criteria for ICH E6(R2) GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual
recognition of GCP training among trial sponsors.
Program
The Principles of ICH E6(R2) Good Clinical Practice
GCP – 10 Rules of the Thumb
Break
Responsibilities in a Clinical Trial
Training Test
Additional documentation:
ICH E6(R2)-GCP Guideline for GCP
FDA Guidance for Industry
Example of an FDA Warning Letter