Major topics of the training:

The course is a intended for clinical research professionals with knowledge of ICH -GCP (International Council on Harmonization and Good Clinical Practice) E6 (R2). It is designed to refresh, update and deepen the knowledge of ICH-GCP. It is an interactive course with real life scenario’s and Q&A session.

• Introduction (History, Scope, 13 Principles)
• Subject Protection (Ethics Committee, Informed Consent)
• Documentation (Protocol, Protocol Amendments and Deviations, Source documents, Case Report Forms, Essential documents, Good Documentation Practices)
• Monitoring
• Quality Management
• Safety Reporting
• Relationship with other documents
   

Attendees will receive a training certificate and a pdf. of the course presentation

 

Who should take the course?

Participants need prior knowledge of ICH-GCP E6. The course is relevant to any research professional active in clinical investigations.

For clinical research site staff we recommend the training: ICH E6 GCP (R2) training for Investigators and Site Personnel 

 

Duration: 120 minutes

Price: 185 € (Excluding VAT chargeable in Belgium and EU)

Course dates (Live webinar):

Thursday September 16, 2021 at 20:00 CET

Tuesday  September 28, 2021 at 15:00 CET

 

Other dates will be published shortly

 

Booking on to a course: 

If you want to register for this course, please send an email to training@aml-research.be and mention:

Course title
Course date
Title, First Name, Last Name and email addresses of trainees
Invoice details

 

Requests for registration should be send at least 3 days (72 hours) prior to the course date.

We will then provide you via email with a confirmation of registration and further information.

AML has the right to cancell the course if there are not more then 3 participants registered.