A GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) Refresher Course is now available to organizations for no additional fee (with a base subscription) or to independent learners for $110/learner.
This course was developed as collaboration between the CITI Program and CITI Canada. This discipline-neutral course focuses on International Conference on Harmonisation (ICH) requirements, and this ICH E6 GCP Investigator Site 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. Click here for more information on TransCelerate attestations.
The refresher course is meant to reinforce the importance of concepts covered in the basic level GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) course. It is recommended that learners complete this refresher course three years after completing a basic GCP course, but it is up to each organization to determine whether and when refresher training is appropriate for its learners.
- International Conference on Harmonisation (ICH): GCP Requirements
- Investigator's Responsibilities and GCP
- Informed Consent
- Safety Management
- Investigational Product (Drug) Management
- Audits, Inspection, and Monitoring of Research Studies
- Sponsor Responsibilities and GCP
How to Proceed
- Subscribe as a new organization
- Subscribe as an existing organization
- Subscribe as an independent learner
- Review the demo version