Reading and Understanding a CITI Program Completion Report for Good Clinical Practice (GCP) TransCelerate BioPharma Mutually Recognized Training

You must complete a GCP course after the effective date to receive mutual recognition for training. The Completion Report will contain specific language identifying the GCP course name, version number, completion date, and information regarding mutual recognition. 

Steps to Mutual Recognition for GCP Training


How do I know if I have completed my GCP course after the effective date?

Various CITI Program 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.

You can refer to the table below for the course names and their effective dates.
 
GCP Basic Courses
 
  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) 
    • Version 1 - 7 May 2015
    • Version 2 - 20 Jan 2017
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
    • Version 1 - 20 Nov 2013
    • Version 2 - 20 Jan 2017
GCP Refresher Courses 
 
  • GCP FDA Refresher
    • Version 1 - 11 Mar 2016
    • Version 2 - 25 Jan 2017
  • GCP ICH Refresher
    • Version 1 - 19 Mar 2015
    • Version 2 - 25 Jan 2017
  • GCP SBR Advanced Refresher
    • Version 2 - 4 Apr 2018
CITI Canada's GCP Courses 
  • Good Clinical Practice (GCP) – Canada
    • Version 1 - 28 Mar 2014
    • Version 2 - 4 Apr 2018
  • CITI Canada GCP Refresher
    • Version 1 - 19 Mar 2015
    • Version 2 - 25 Jan 2017
Spanish Translations of GCP Courses
  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) Course – Spanish
    • Version 1 - 16 Dec 2015
    • Version 2 - 25 July 2017
  • GCP for Clinical Trials with Investigational Drugs (International / ICH Focus) – Spanish 
    • Version 1 - 18 Mar 2015
    • Version 2 - 13 July 2017
Portuguese Translations of GCP Courses
  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) Course – Portuguese 
    • Version 1 - 1 Jan 2016
    • Version 2 - Pending
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) – Portuguese 
    • Version 1 - 1 Jan 2016
    • Version 2 - Pending

If you completed a GCP course before the effective date for version 2, you can return to the course and re-complete the modules (after effective date for version 2) to receive credit for completing version 2. 


How Do I Read My Completion Report?

Your CITI Program Completion Report has two parts.​
  1. Part 1 (Requirements Report) shows quiz scores at the time you "completed and passed" the course requirements, and is "frozen" thereafter.
  2. Part 2 (Transcript Report) is continually updated and shows the most recent (up-to-date) quiz scores and modules completed (even optional modules that were not part of the original course requirements).


Once a Completion Report has been issued you will not be able to change the scores on Part 1. 

* A Completion Certificate is not a Completion Report. The Completion Certificate i a one-page ("diploma-like") confirmation of the course completion. It does not contain any of your coursework (no listing of modules or quiz scores).


Expiration Date

If your organization has set an expiration date for the course, this date is shown on both the Completion Report (Requirements Report) and Completion Certificate. You may also review expiration dates through the "My Reports" link on your learner menu.
 
See the Transcelerate BioPharma website on Mutual Recognition for more information about training time frame and expectations.
 

Course Transcript - Description Field

GCP Completion Reports contain language to help sponsors, monitors, auditors, and others know that you have completed a mutually recognized training. On the Completion Report’s Transcript Report, there will be a statement in the Description field that identifies:

  • Course Name
  • Version
This statement will also include that the learner has completed all the attested CITI Program modules from the course that meets the minimum criteria for ICH GCP training identified by TransCelerate BioPharma.

Note: The description field will only show if the learner completed the required modules within the effective period of time.


Transcript Report Example:

Description Example:

Last Updated: 09-Jan-2019 4:42 p.m. EST
admin@citiprogram.org
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seconds ago
a minute ago
minutes ago
an hour ago
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