Guide to GCP Mutual Recognition Completion Documentation

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Guide to GCP Mutual Recognition Completion Documentation

 

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 the 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.

 

Mutual Recognition Statement

 

To verify that a learner has completed and passed a mutually recognized GCP course, the following statement will be on the completion document (see examples below with the blue arrows). It will specify the course name and version number of the mutually recognized course.

 

“This GCP training contains all of the attested CITI Program modules from the << Course Name Version # >>. 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.”

 

If the above statement containing the name of the course and version is not there, then the learner has not met the requirements.

 

Because institutions may customize the name of the curriculum groups, learner groups, and stages, these should not be used to determine eligibility or to compare documents.

 

Institutions may also customize courses. Therefore, the actual Completion Report submitted by an individual may contain more modules than required to meet mutual recognition and the order of modules may be different. For that reason, we advise not comparing the module lists and instead only look for the mutual recognition statement on the Completion Report.

 

For more information, visit CITI Program’s website and the following Support Center articles: