Magazine: FGK Clinical Research

GCP Snippets: A Revamped ICH GCP Enters its Fourth Decade

The 30 year old ICH E6 guideline is completely revamped, resulting in the 2025 version called ICH E6 (R3), which will probably be completed until 2026 with Annex 2. Come with us on a journey through the depths of the GCP jungle in search of truths ... and puns

GCP Snippets: A Treatise of Essentiality in Two Lists

In summary, we see tracks of improvements of the criteria used for Essential Documents in the new ICH E6 (R3), but we have to see how ICH E6 (R3) Annex 1, Appendix C is handled in the practice of audits and inspections.

GCP Snippets: Investigators Out of Site

While the mid-90ies version of ICH E6 depicted the informed consent with pen and paper the brand new ICH E6 (R3) shows that it can handle cutting edge technology with ease. In line with this, the "investigators" are released from their vintage study centers...

GCP Snippets: Copies Without Originals

ICH E6 (R3) features an inconspicuous, but troublesome concept called “certified copy” but does not define what “the original” is and for many documents it is hard to classify them as originals or copies.

GCP Snippets: Facing Patient Facing Documents

Does ICH E6 (R3) protect participants more than the EU Clinical Trials Regulation against rogue documents? Come with us on a bumpy ride from ICH GCP to the EU rules and back.

GCP Snippets: Protocol checklists in competition

Although ICH E6 (R3) does not feature a fully comprehensive checklist of all possible and all necessary protocol elements, it contains the most widely employed description of general protocol content.

GCP Snippets: Compliance with the unknown

Usually sponsors and investigators confirm compliance by signing on a dotted line beneath this very statement. But do they actually comply with ICH GCP, are they enabled to comply, and could they know how to comply?

GCP Snippets: From subtext to metadata

ICH E6 (R3) has a completely new chapter, which is called “Data governance – investigator and sponsor”. You might wonder whether this new chapter was added to ICH GCP to address issues that emerged as being critical in real life – or if it was added to codify an emerging practice.

GCP Snippets: Is ICH GCP applicable in the European Union (and elsewhere)?

ICH GCP is not dead, even in Germany it is alive and kicking. In 2024, the inspection reports of a German authority for a clinical trial that is subject to the CTR made numerous references to ICH E6, but none to the CTR (!). Let's dissect the applicability of ICH GCP as far as possible.