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

You must complete a GCP course to receive mutual recognition for training. The Completion Report and Certificate 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?

Each GCP course has an effective date for when it is mutually recognized. 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.
 

What do the version numbers mean?

The version numbering refers to the version of ICH E6, except for the GCP FDA Refresher course (see the note later in this article for more information). For Version 1, the course meets the ICH E6 minimum criteria. For Version 2, the course meets the ICH E6(R2) minimum criteria. For Version 3, the course meets the ICH E6(R3) minimum criteria.

If you completed a GCP course before the effective date for a new version, you can return to the course and re-complete the modules (after the effective date for the new version) to receive credit for completing the new version. However, re-completing modules will not change or extend your renewal date.
 

Which GCP courses meet mutual recognition?

You can refer to the table below for the course names and their effective dates.  For the full listing of required modules for each course for mutual recognition, refer to Support article List of TransCelerate Mutually Recognized GCP Training.

Documentation of Training

As of 2 November 2020, CITI Program provides two types of completion documentation (a single Certificate and two-part Completion Report) for mutual recognition. Either can be used as documentation of training for mutual recognition.

NOTE: Certificates printed prior to 2 November 2020, do not contain the mutual recognition statement. Only the two-page Completion Report contained the mutual recognition information. However, the learner may generate a revised certificate after 2 November 2020 which will include the mutual recognition statement. For regenerating a certificate see How do I access my Completion Report/Certificate?

If your certificate has the statement “Do not use for TransCelerate mutual recognition (see Completion Report)” then it is an older version of the certificate, and you should regenerate it.

What is the difference between the Certificate and Completion Report?

A Certificate is not a Completion Report. The Certificate is 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).
 

Which completion document should I submit for mutual recognition?

Either the Completion Report or Certificate can be submitted to sponsors or monitors for verification of training.

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 or dates on Part 1. 
 

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.

Sample Transcript Report with Mutual Recognition Statement:

Sample Certificate with Mutual Recognition Statement:

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.


For additional information email us at support@citiprogram.org or call 888.529.5929.