GCP Training Mutual Recognition

The TransCelerate Site Qualification and Training (SQT) Initiative has developed a mutual recognition program for ICH E6 Good Clinical Practice (GCP) Training, targeted to investigator site personnel. To connect with the SQT Initiative about the MR GCP program, send an email to .

*Please note TransCelerate does not provide GCP training and this is not a certification program.

What is the Mutual Recognition Program?
What are the Minimum Criteria?
What are the Basic Program Expectations?
Where is the list of GCP Training meeting the minimum criteria?
How do I get on the list of GCP Training meeting the minimum criteria?

What is the Mutual Recognition Program?

TransCelerate Member Companies have developed guidelines to give innovative drug companies the comfort necessary to accept and rely on Member Companies’ and Training Provider’s investigator site personnel ICH GCP training meeting identified Minimum Criteria.

What are the Minimum Criteria?

The Minimum Criteria for ICH GCP training of investigators and site personnel must include the following sections:

  • GCP Overview
  • Principles of ICH GCP
  • Investigator Responsibilities

It is expected that the investigator understands and complies with all applicable local and national regulations. To be eligible, the GCP training must meet the Minimum Criteria described in this document (TransCelerate GCP Training Minimum Criteria) and Program Basic Expectations.

What are the Basic Program Expectations?

  1. GCP Training Timeframe

The ICH GCP Training certificate should be dated within 3 years of start of a new study at the site. Investigators are not required to retake GCP training during study (unless required by local regulation or at the discretion of the sponsor).

  1. Certificates

TransCelerate Member Companies will issue a GCP training certificate upon completion of the training course, which may be recognized by other TransCelerate Member Companies, making it unnecessary to train separately for each participating company.

Training Providers cannot use the TransCelerate brand on their certificate. However, if Training Providers would like to add a statement to their own certificates, the following text must be used: “This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.”

  1. Audits and Inspections

If requested during Audits or Inspections at member companies or investigator sites, you will be required to provide a secure copy of the training materials within 48 hours. Any requests for these training materials will be done via TransCelerate.

Where is the list of GCP Training meeting the minimum criteria?

Lists of the ICH GCP Training Meeting the Minimum Criteria are provided below:

 

How do I get on the list of GCP Training meeting the minimum criteria?

TransCelerate Member Companies

Member Companies who wish to have their investigator ICH GCP training details posted on the TransCelerate website should connect with their TransCelerate through their SQT representative.

Training Providers

Training Provider companies or organizations who wish to have their investigator ICH GCP training details posted on the TransCelerate website to facilitate and enable acceptance by Member Companies, should:

  • Evaluate their GCP course against the General Guidelines (ICH GCP) and the Minimum Criteria. We encourage you to save this document as you approach the attestation process.
  • Submit an electronic Attestation form verifying that their training satisfies the Minimum Criteria, and provide a sample of the Training Providers completion certificate using the link below.
  • **Training Provider is any company/professional organization (e.g. CRO, Hospital, Ethics committee, training consultant, etc.) that develop and deliver Training.
  • ***If a Training Provider would like to add a statement to their own certificates (issued upon completion of the GCP Training) regarding that training has been attested to meet the TransCelerate minimum criteria, this is the only text allowed: “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.”

The GCP Mutual Recognition Self -Attestation Process is under maintenance. Please check back on April 4, 2017 to submit your training details. If you need to reach TransCelerate sooner, please send us an email at  .

 Additional Submission (Member Company and Training Provider)

For the following situations, please submit again according to the applicable process:

  • Update to previously submitted training course
  • Multiple translations of the same course
  • Additional or refresher courses

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