The TransCelerate Site Qualification and Training (SQT) Initiative has developed a Mutual Recognition (MR) 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, ask questions, or provide feedback please send an email to SQT@transceleratebiopharmainc.com. Please note TransCelerate does not provide GCP training and this is not a certification program.
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 is the Minimum Criteria?
To be eligible, the GCP training must meet the Minimum Criteria described in this document (TransCelerate GCP Training Minimum Criteria) and Program Basic Expectations. It is expected that the investigator understands and complies with all applicable local and national regulations.
What are the basic program expectations?
- GCP Training Timeframe
TransCelerate recommends that Site Investigators complete GCP training within three (3) years of the start of a new study. Investigators are not expected to retake GCP training during the study (unless required by local regulation or at the discretion of the sponsor).
Training Providers* will issue a GCP training certificate upon completion of the training course, which may be recognized by TransCelerate Member Companies, making it unnecessary for sites to re-train for each new study start-up across sponsor companies. As part of the self-attestation process necessary to participate in this program, TransCelerate will review submitted certificates for completeness.Your certificate must be a template and follow the below guidelines:
- Contain name of company issuing the certificate or company logo
- Contain name of Training Program or Course
- Contain version identifier (number, date or both) of Training Program or Course
- Contain field for date training was complete (leave field blank on template)
- Not contain any individuals’ personal information (i.e. participant name)
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.” Please note, some Training Providers* include expiration dates on their certificates that are unrelated to this Mutual Recognition GCP Program and are typically at the request of the Training Provider’s client. Sponsors may decide to recognize a certificate regardless of an expiration date being present on a certificate.
- 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 Courses meeting the Minimum Criteria?
The list of Training Providers* ICH GCP Training Meeting the Minimum Criteria can be accessed here.
How do I get added to the list of GCP Training Courses meeting the Minimum Criteria?
TransCelerate Member Companies and other Training Providers* who wish to have their investigator ICH GCP training details posted on the TransCelerate website 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, using the “add course details” link at the top of this page, verifying that their training satisfies the Minimum Criteria, and provide a sample of the completion certificate. Please ensure information provided on the electronic Attestation form matches sample certificate.
TO SELF-ATTEST YOUR TRAINING – CLICK HERE
When do I need to re-attest to meeting the Minimum Criteria?
Should one of the below situations apply, you must re-submit the electronic self-attestation form following the applicable process:
- Update to previously submitted training course
- Multiple translations of the same course
- Additional or refresher courses
TransCelerate may send you emails reminding you to consider re-submitting the electronic self-attestation form.