On June 14, 2017 the new ICH GCP is in effect: Addendum R2. In hospitals, pharmaceutical companies and CROs, the agreement has been made that a GCP training certificate obtained is valid for 2 to 4 years. But what if, in the meantime the legislation is updated as in this case? What is the value of your previously obtained GCP certificate?
The annoying news is: There is no legal requirement for the validity of a GCP training or certificate. And no central authority determines whether a certificate is still valid. What the ICH GCP says is that you have to be aware of the applicable legislation. This implies that, as soon as there is a change in the applicable legislation, the researcher must inform himself of the contents. Ideally this can be proven with the aid of a training certificate.
How it is defined in ICH-GCP:
ICH GCP (E6 R2) principle 2.8: “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task (s).”
ICH GCP (E6 R2) article 4.1.1: “The investigator (s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement (s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority (ies). ”
ICH GCP (E6 R2) article 4.1.3: “The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.”
This is enshrined in European legislation:
“The qualifications of the researchers are described in a current curriculum vitae and other relevant documents. A description is also given of previous training on the principles of good clinical practice or work experience with clinical trials and patient care.”
From a legal point of view, it is an obligation to show that you are aware of GCP and applicable lawsuch as the European legislation and the WMO. If these laws and rules change, as is currently the case, you should be able to demonstrate that you know about it.
How you do that is not specified and so depends on the requirements of the institute or the client. The requirement may be that a BROK certificate must have been obtained (UMCS), that a WMO/GCP certificate (peripheral and STZ hospitals) must be obtained or that a BROK WMO/GCP Exam ( Umcs and some STZ hospitals).
At GCP Central we make this a lot easier for you: we also train our students after obtaining their GCP certificate in legislative updates. You don’t have to do the entire training again, but only the modified chapters. We will record your update training for you, according to GCP.
We offer this service for free if there is legislative updates are within 1 year after a student obtains a license. A student can extend the license (paid) after 1 year to be able to use our services afterwards. We call that continuous learning.