It’s official! TODAY, the International Council for Harmonisation (ICH), as is their new name as of October 20151, has published a press release2, declaring that they adopted revision 2 of their E6 guideline, Good Clinical Practice (ICH-GCP or ICH-E6(r2)).
As the official final guideline is not yet published on their website, currently we still have to go on the final draft3 for what the changes will be. The amazing thing about this second revision (the first constituted minor textual changes, no content changes) is that the outlined responsibilities in the original version have not changed! R2 only adds to the original text. It doesn’t change anything from what we already know and do. It mainly specifies some responsibilities and adds today’s world to a 20 year old guideline.
Here, in short, are the six most important updates to ICH-GCP. If you’re interested in reading more detail on these updates, I have a white paper available for download, outlining the expected changes further. Please subscribe to our newsletter to receive this.
1. Quality Management
New: Yes, but then again… Affects: All Clinical Research Professionals
The biggest impact of the update is the added Quality Management. ICH has taken the FDA and EMEA guidance on the Risk Based Approach to monitoring and combined those two and added more to come to Quality Management in GCP.
2. Investigator Oversight
New: No Affects: Principal Investigators
Over the past years, lack of oversight has remained a common audit/inspection finding for sites that have a Principal Investigator (PI) who does not actually get involved in the trials that are being run on their site. ICH is adding language to emphasise the need for PI oversight. Nothing new, that oversight was always a responsibility! However the number of findings that continue to occur warrant a stronger emphasis on this responsibility.
3. Dealing with Noncompliance
New: Somewhat Affects: Both site and sponsor staff
Noncompliance has never been a focus of GCP. The focus has always been on ensuring and achieving compliance. The expected addition is brief, however not insignificant. With a few choice sentences, GCP states that the sponsor should perform a Root Cause Analysis (RCA) and implement Corrective And Preventive Actions (CAPA).
4. Sponsor – CRO Oversight
New: Shouldn’t be Affects: Sponsors and CROs
The fact that Contract Research Organisations are being retained by sponsors is nothing new. The continued responsibility of the sponsor for the work done has also never been challenged. Still, adding that the sponsor ‘should maintain oversight’ over retained services is apparently necessary. Audits and inspections identified that this was not currently happening as diligently as it is needed.
5. Electronic record keeping
New: No Affects: All Clinical Research Professionals
GCP now specifies that when it refers to the requirements of recording information, it applies to both paper and electronic records. Electronic records were already mentioned in the original guideline, now it adds amongst other things the need for maintaining SOPs for the use of electronic systems.
6. (Essential) Documents
New: not really Affects: All Clinical Research Professionals
Instructions on how to create source data been added: ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete.
GCP R2 is adding a definition for ‘certified copy’ to the glossary as well as the monitoring plan.
The specification that the investigator should have control of all generated essential documents and records (and this includes the CRF data) before during and after the trial most likely has the most impact here.
Those are the changes as we expect them to be published later this month. More extensive coverage of each of the topics will be published on this blog when the update is online. For now, if you’re interested in reading more detail on these updates, I refer again to the available white paper download, outlining the expected changes in more detail. Please subscribe to our newsletter to receive this.
http://fourplusmore.com/wp-content/uploads/2016/11/update-2.jpg375500Eric Klaverhttp://fourplus.wp.go2people.nl/wp-content/uploads/2016/05/side-300x104.pngEric Klaver2016-11-17 00:23:532016-11-24 02:15:47The 6 most important updates to ICH-GCP