The purpose of this Support Center is to provide technical support, resources, tips, and answers to frequently asked questions regarding the CITI Program. We welcome contributions and feedback so please contact us with anything regarding the CITI Program or this Support Center.

New GCP Refreshers: FDA Refresher and Device Refresher

Two new refresher courses in the Good Clinical Practice (GCP) series are available for to subscribing organizations at no additional cost or to independent learners for $110/course. 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.


GCP FDA Refresher

GCP FDA Refresher (Good Clinical Practice, CITI Program)

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 (Good Clinical Practice, CITI Program) GCP Device Refresher

This course is meant to reinforce the importance of concepts covered in the basic level GCP for Clinical Investigations of Devices course. These device courses cover FDA regulations as well as International Organization for Standardization Guidelines (ISO 14155:2011).

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

Add these courses to your organization's learner groups by contacting support@citiprogram.org.

Review the demo versions.

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Last Updated: 25-Jan-2017 3:10 p.m. EST

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