The good news for us all is that they haven’t changed any of the existing guidelines- so we don’t have to re-learn everything from scratch or change anything we are already doing- phew!
They have only added some additional aspects. So the question everybody is asking….. what did the International council for Harmonisation (ICH) add when they released the new guidelines?
Well to make that simple we have summarised this in to 6 key points.
1. Quality Management-ICH has taken guidance from the FDA and EMEA on taking a risk-based approach. This is definitely a new approach for GCP, as risk-based monitoring has never been included in the guidelines. In fact, many sponsors fully controlled the data collected and micro managed the sites. Now sponsors are able to focus on trial activities essential to ensuring human subject protection and the reliability of trial results.
2. Investigator oversight- This is not particularly something new. However, it is something that was continuously being highlighted during audits. ICH has added language to emphasize the need for PI oversight.
3. Dealing with non-compliance– Non-compliance has never been the focus of GCP as the focus has always been on ensuring compliance. Now GCP states that the sponsor should perform a root cause analysis and implement a CAPA and emphasises the need to inform Regulatory authorities of any serious breaches!
4. Sponsor CRO oversight- the fact that CROs are being used by sponsors is nothing new. The responsibility has always been with the sponsor. ICH has added that the sponsor should maintain oversite and document approval if their services are being subcontracted.
5. Electronic recorded keeping– Obviously in 1996 electronic record keeping wasn’t the thing it is today, so ICH have update the guidelines to match this. They have added some extra words/phrases in the glossary such as ‘validation of computerised systems’. It also emphasises the need for maintaining SOPs when using electronic systems to ensure data integrity during software updates or data migration etc.
Nearly there… bear with me…
Last but not least.
6. Essential documents- The ALCOAC anagram hasn’t changed, but the need for audit trail has been emphasised- especially in regards to source data and documents. Again, a couple of terms have been added to the glossary: ‘certified copy’ and ‘monitoring plan’ to mention a couple. It was also updated to ensure that even when using an electronic version of a CRF that it was accessible even after the trial has ended. Ensuring that the investigator has control, and continuous access to the data and that the sponsor should not have exclusive control.
So, there you have it. ICH GCP E6 R2 addendum in a nutshell. If you want any further information, or you have realised you’re due an update. Perhaps you’re new to GCP. Whatever your reason, head over to our interactive e-learning course for a fun, quick and easy way to further your knowledge and keep your GCP certificate up to date!