Description

Clinical Operations Courses

Taking up the responsibility of a clinical trial is dealing with rules and regulations; during this course you get familiarized with ICH-GCP, the laws and the practicalities of leading a study in your site. You receive hand-on information on informed consent process, safety reporting and audit preparation.

 

Investigators are trained on their specific duties within Clinical Research. In 1 day, they get to understand the regulations, GCP guidelines and their responsibilities with regards to safety reporting and informed consent.  Participants will receive a GCP certificate showing their capacity to work according to the current laws and regulations.

 

Course time
9h00 - 17h00
Who should attend

Medical Doctors looking to participate in Clinical Trials. Investigators conducting Clinical Research.

Programme highlights
  • ICH-GCP and the responsibilities of the investigator
  • The clinical trial as opposed to regular medical practice
  • Informed consent and patient recruitment issues
  • Safety reporting
  • Efficient study management & data recording
  • Audit findings and practical tips for study sites
Learning Objectives
  • To know everything about current clinical practice
  • To understand the responsabilities of a Medical Doctor within Clinical Trials
  • To fully comprehend the safety reporting procedure
  • To be able to get a voluntary and understandable informed consent
  • To give hands-on tips on improving recruitment

Book a course

No session currently available.
In case of interest, please contact us.
 

Testimonials

October 2013

The quiz and cases are an excellent method for teaching these topics.

The trainer was very knowledgable, friendly, passoniate about the topic and an excellent teacher.  We enjoyed every minute of this training.