Aml Research

ICH GCP E6 (R2) training for Investigators and Site Personnel

Major topics of the training:

The course is a comprehensive guide to the basic principles of ICH Good Clinical Practice aimed at investigators and site personnel  who are active in clinical research. It reviews and demonstrates the principles of GCP and meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

The course is adapted to the latest update R2 addendum which was adopted on 15 december 2016 and which will come into effect on 14 June 2017.

This course is not only a comprehensive guide to ICH-GCP but the implementation of GCP requirements is explained and illustrated using real life examples.

Content:

  • What is ICH GCP?
  • Investigator Qualifications and agreements
  • Adequate resources
  • Medical care of trial subjects
  • Communication with IRB/IEC
  • Compliance with protocol
  • Investigational products, randomization procedures and unblinding
  • Informed consent of trial subjects
  • Source documentation  and record keeping
  • Progress reporting/final reports
  • Safety reporting
  • Premature termination or suspension of trials

Who should take the course?

As prescribed by the international standards and requirements, a basic understanding of Good Clinical Practice is prerequisite for anyone carrying out, or involved in, clinical research and clinical trials. The course is therefore relevant to:

  • principal and sub-investigators
  • study coordinators and research nurses
  • site managers
  • other hospital staff or ancillary staff involved in a clinical trial

No prior training in or working experience with GCP is required.

Duration: 60 minutes


Price: 180 € (Excluding VAT chargeable in Belgium and EU)


Course dates (webinar):

  • Friday February 17, 2017 at 11:00 CET
  • Tuesday May 9, 2017 at 14:00 CET
  • Friday September 15, 2017 at 14:00 CET
  • Tuesday December 12, 2017 at 11:00 CET

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.