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.

How to Determine if a GCP Course Meets TransCelerate Minimum Criteria

Ten of CITI Program's Good Clinical Practice (GCP) courses meet 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 GCP Basic Courses

  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) (Effective 7 May 2015)
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) (Effective 20 November 2013)

TransCelerate GCP Refresher Courses

  • GCP FDA Refresher (Effective 11 March 2016)
  • GCP ICH Refresher (Effective 19 March 2015)

CITI Canada's TransCelerate GCP Courses

  • CITI Canada GCP (Effective 28 March 2014)
  • CITI Canada GCP Refresher (Effective 19 March 2015)

Translations of TransCelerate GCP Courses

  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) - Spanish (Effective 16 December 2015)
  • GCP for Clinical Trials with Investigational Drugs (International / ICH Focus) - Spanish (Effective 18 March 2015)
  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) - Portuguese (Effective 1 January 2016)
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) - Portuguese (Effective 1 January 2016)

Study monitors or site administrators can confirm that a learner has completed one of these courses by cross referencing the module titles and ID numbers listed on the learner’s completion report to the course listings below, or via the TransCelerate Biopharma website. If a learner’s completion report reflects, at a minimum (additional modules could be listed), all modules listed in one of these courses, then, the monitor/administrator can confirm that the learner has completed a course that meets the TransCelerate minimum criteria.

GCP for Clinical Trials with Investigational Drugs and Medical Devices (US FDA Focus)

GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)

GCP FDA Refresher

GCP ICH Refresher

CITI Canada GCP

CITI Canada GCP Refresher

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) - Spanish

 

GCP for Clinical Trials with Investigational Drugs (International / ICH Focus) – Spanish

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) - Portuguese

GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) - Portuguese

Last Updated: Feb 13, 2017 10:31AM EST

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