CITI Program Guide to GCP Mutual Recognition

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CITI Program Guide to GCP Mutual Recognition

Which courses are mutually recognized?

The following courses are mutually recognized when all required modules are passed.

 

Basic GCP courses

  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
  • ​GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)

Refresher GCP courses

  • GCP FDA Refresher
  • ​GCP ICH Refresher
  • ​GCP SBR Advanced Refresher

CITI Canada's GCP Courses

  • Good Clinical Practice (GCP) - Canada
  • ​CITI Canada GCP Refresher
  • Good Clinical Practice (GCP) – Canada (French)
  • CITI Canada GCP Refresher (French)

Translations of GCP Courses

  • ​GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) Course - Spanish
  • GCP for Clinical Trials with Investigational Drugs and Biologics (International / ICH Focus) - Spanish

Further information can be found in Support article

For Investigators and Research Staff

You must complete the required modules for a GCP course to receive mutual recognition for training.

Your Completion Report and Certificate will contain specific language identifying the GCP course name, version number, completion date, and information regarding mutual recognition.

 

What if the mutual recognition statement isn’t there?

If the mutual recognition statement is not present on your Certificate or Completion Report, you did not complete all the required modules for mutual recognition. You may need to return to the course and complete modules designated “supplemental” by your organization. The list of required modules for mutual recognition for each course can be found in the Support article List of TransCelerate Mutually Recognized GCP Training. 

Note: If you generated your Certificate prior to 2 November 2020, then the mutual recognition will not be present on it. You will need to re-generate your Certificate to have the 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.

 

Which completion document can I submit to the Shared Investigator Platform (SIP)?

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 and submitted to SIP as long as it contains the mutual recognition statement.  If the mutual recognition statement is not present on a certificate issued prior to 2 November, regenerate your Certificate to obtain an updated version of it and confirm the statement is now present prior to submitting in SIP.

For regenerating a certificate see How do I access my Completion Report/Certificate?

How do I know which course I completed when I submit to SIP?

Organizations may assign varying names to learner groups, gradebooks, and stages. To find the name of your CITI Program GCP course, you can look at the mutual recognition statement on your Certificate or Completion Report. It will contain the name of the course and version number.

 

Example:

“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.”

 

For example, for the ICH E6(R3) version of the CITI Program course GCP ICH Refresher, here is its mutual recognition statement:

 

“This GCP training contains all of the attested CITI Program modules from the GCP ICH Refresher Version 3. 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.”


Should I submit or self-attest my CITI Program GCP course myself to TransCelerate?

No, you should not submit or self-attest a course to TransCelerate BioPharma. CITI Program submits and self-attests on behalf of our GCP courses.

We ensure that our mutually recognized GCP courses satisfy the requirements for mutual recognition and that completion documentation reflects the course name, version number, and all required elements (including TransCelerate information) if a learner completes a mutually recognized course.

Further information can be found in Support articles

For Sponsors and Monitors

To verify an individual has completed a mutually recognized GCP course, you can review the Completion Report or Certificate.

There will be a statement on the bottom of the Certificate or on Part 2 – Coursework Transcript of the Completion Report that identifies the course name, version number, and attests to mutual recognition.

 

Example:

“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 individuals need assistance accessing their completion documents, please refer them to Support. All completion documents are available under their Records tab once they log-in.

Further information can be found in Support articles