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The CITI Program is proud to announce two new refresher courses in the Good Clinical Practice (GCP) series that are available for no additional cost with the base organizational subscription. See below for more about the newly added GCP FDA Refresher and GCP Device Refresher courses. It is recommended that learners complete refresher courses 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.
CMEs: Credits for Physicians, Psychologists, Nurses and Other Participants are pending.
New Course – GCP FDA Refresher (April 2016)
A new refresher course entitled GCP FDA Refresher is now available. This refresher is meant to reinforce the importance of concepts covered in the basic level GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) course.
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. Organizations that wish to utilize this course in keeping with the minimum criteria must designate all available (FDA Refresher) modules as “Required.”
Modules
- GCP Refresher – International Conference on Harmonisation (ICH): GCP Requirements
- GCP Refresher – Investigator’s Responsibilities and GCP
- GCP Refresher – Informed Consent
- GCP Refresher – Safety Management
- GCP Refresher – Investigational Product (Drug) Management
- GCP Refresher – Audits, Inspection, and Monitoring of Research Studies
- GCP Refresher – Sponsor Responsibilities and GCP
- GCP Refresher – Conducting Clinical Investigations of Devices
- GCP Refresher – Review of U.S. FDA Regulations for Investigational Devices
- GCP Refresher – Additional GCP Standards for International Clinical Investigations of Devices
- GCP Refresher – Informed Consent and Exceptions to the Requirement for Obtaining Consent for Clinical Investigations of Devices
- GCP Refresher – Oversight of Clinical Investigations of Devices
- GCP Refresher – Reporting Requirements for Clinical Investigations of Devices
GCP Device Refresher (April 2016)
Modules
- GCP Refresher – Conducting Clinical Investigations of Devices
- GCP Refresher – Review of U.S. FDA Regulations for Investigational Devices
- GCP Refresher – Additional GCP Standards for International Clinical Investigations of Devices
- GCP Refresher – Informed Consent and Exceptions to the Requirement for Obtaining Consent for Clinical Investigations of Devices
- GCP Refresher – Oversight of Clinical Investigations of Devices
- GCP Refresher – Reporting Requirements for Clinical Investigations of Devices
How to Proceed
- Add these modules to your organization’s learner group(s)
- Review the demo versions
- Email support@citiprogram.org for more information
