With all the changes around GCP that have taken place recently, a lot of companies and a lot of clinical research professionals are asking the question: do I have to retake Good Clinical Practice (GCP) training?
How often should we be taking GCP training?
ICH states that it is up to the Sponsor’s discretion as to how often you should be taking GCP training. A lot of companies do set the guidelines of every two years, but these are not official guidelines. However, in recent audit findings, the Regulatory Authorities (RA) have found that people are not being trained frequently enough on GCP, meaning lots of issues are arising during studies. Sponsors are being asked to tighten up on how often their employees take their GCP training. The FDA in particular are, in their own words: “coming down hard on Sponsors regarding GCP training.” This suggests that all staff should be up to date with all the training required to carry out their job, which includes being up to date with all GCP guidelines.
What about the E6R2 update?
Well as you have just read above, the requirement is that you are up to date. So if you haven’t taken GCP training since the E6R2 update was implemented in June 2017, then you will have to familiarise yourself with the new changes. The good news is you don’t have to fully re sit GCP training, you can just do the update with proof that you have done so, along with your up-to-date GCP certificate. However, depending on how long ago you took your GCP training, it may well be worth retaking the full course as long as the training provider has included the recent update, and remember you can never have too much training!
In line with audit findings, the RA also have suggested that people remain up to date with their Informed Consent training. This is one of the biggest bug bears in audit findings: Informed Consent not being taken properly. I was recently made aware of a study in which a whole site’s data was unable to be used as the Informed Consent was incorrectly taken, things such as: not dated, not signed, taken after procedure had started or the wrong version being used. If the site staff had recently had their training updated, this would have saved the study having to abandon the site data and saved the Sponsor time and money.
Section 8 of GCP is about Essential Documents. This is another area that always crops up during audits. Although the GCP guidelines cover Essential Documents, it does not do so in great detail, so it is important to make sure you are up to date with your Essential Documents training –especially if you are working at sites. Proper documentation is critical to the success of a clinical study. Every aspect of the study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) guidelines and Good Documentation Practice (GDP) guidelines and with all applicable regulations. Again, there is no set rule as to how often you need to take Essential Documents training. I would recommend taking this as often as possible to keep yourself up to date and your mind fresh, in order to avoid getting some negative audit findings.
If you are reading this and starting to think: “I haven’t taken these training modules for a while”, or even worse, you can’t actually remember when you last took them (don’t worry we have all been there!), pop over to trainingonline4u.com and take a look at the training offered.