TRAINING CENTRE

ICH E6(R2) GCP Investigator Site Personnel training

Our ICH E6(R2) 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
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Training Options

Workshop: Training given in the form of a workshop for up to 8 attendees, with possibility to upgrade the GCP content with basic regulatory requirements concerning clinical research. Training duration is approximately 6 hours and includes a knowledge test at the end of the workshop.

Lecture: Training for more than 8 attendees, with possibility to upgrade the GCP content with basic regulatory requirements concerning clinical research. Training duration is approximately 6 hours and includes a knowledge test at the end of the lecture.

eLearning: Training is also available on our online eLearning portal. It is recommended for refresher trainings. Content is available in Slovenian or English language. Training is self-paced and includes a quiz at the end of the training. eLearning Centre User Manual.

Certification

Our ICH E6(R2) 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 E6(R2) GCP Training meets the Minimum Good Clinical Practice Training Criteria for Investigators and Site Personnel, which is 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(R2) 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.