TRAINING CENTRE


Our ICH E6 GCP Investigator Site Personnel training gives Investigators and their clinical teams all the knowledge required for running clinical trials in compliance with Good Clinical Practice. The GCP training is available in Slovenian and English language and can be delivered at your preference.

The following topics are covered by the training:

  • 1. The Principles of ICH GCP
  • 2. Investigator Qualifications and Agreements
  • 3. Adequate Resources
  • 4. Medical Care of Trial Subjects
  • 5. Communication with IRB/IEC
  • 6. Compliance with Protocol
  • 7. Investigational Products
  • 8. Randomization and Unblinding
  • 9. Informed Consent of Trial Subjects
  • 10. Records and Reports
  • 11. Progress Reporting / Final Reports
  • 12. Safety Reporting
  • 13. Premature Termination or Suspension of Trial

At your request, we can upgrade this training to include training on EU and local regulatory requirements to ensure compliance in performing clinical research.

Training duration is approximately 6 hours and it includes a knowledge test at the end of the training. Training can be delivered as an interactive workshop for groups up to 8. For larger groups the training is in form of a lecture.

Certification

Our GCP Training includes a knowledge check at the end of the training which consists of 20 questions. One must achieve 80% of correct responses to earn the training certificate. Training certificate is valid for 3 years. After this period a refresher training on GCP should be completed to extend the certification.

Recognition by TransCelerate BioPharma

Our ICH-GCP Training 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. TransCelerate members have developed guidelines to give innovative drug companies the comfort necessary to recognize and rely on another member’s or Training Provider’s investigator site personnel GCP training meeting the identified Minimum Criteria. ADAX ICH E6 GCP Investigator Site Training meets all these minimum criteria and is recognized by all TransCelerate members as a training provider.

For more details, please see our brochure or contact us directly at info@adax.si.