Good Clinical Practice (GCP) - ISO 14155 vs. ICH

Mark Meer

Trusted Information Resource
#1
Doing some Googling/Reading online, and am finding myself a bit confused as to references to "Good Clinical Practice (GCP)".

Sometimes a standard is specified (ISO 14155), sometimes the International Conference on Harmonisation (ICH) is referenced, but often there is just a reference to following "GCP".

So, question: What is the effective difference between GCP (ISO 14155), and GCP (ICH)?

If I'm considering study protocols, is there reason to reference one over the other?
I've read that ISO 14155 has been updated for closer alignment to ICH-GCP, which seems to indicate there is a fair degree of overlap....

Any insight, or reading links much appreciated!
MM
 
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JJ_FDA

Involved In Discussions
#2
I come from the drug side, not the medical device side so maybe it's not surprising that I've never heard of the ISO standard. What I do know is that ICH GCP is the universal standard for the conduct of pivotal clinical trials full stop and is enshrined in law / regulation in participating countries. I would be curious to hear what the applicability of the ISO standard is.
 

Mark Meer

Trusted Information Resource
#3
...What I do know is that ICH GCP is the universal standard for the conduct of pivotal clinical trials full stop and is enshrined in law / regulation in participating countries. I would be curious to hear what the applicability of the ISO standard is.
That's what I'm not so sure about: your "universal standard", and "full stop" assertion - ...I don't know that it's that cut-and-dry (at least for medical devices). Maybe it is in the drug realm as, from my understanding, the ICH-GCP was originally developed specifically for drug trials. ISO 14155, on the other hand, was created specifically for medical devices, and apparently aligns quite closely with ICH-GCP. However, aside from some terminology differences, I'm not certain what are the substantive differences.

With respect to applicability, the US FDA's FAQ on Acceptance of Clinical Data to Support Medical Device Applications cites both, and states: "Although we make reference throughout these answers to relevant portions of ISO 14155:2011 and ICH E6, we remind sponsors and applicants that they may choose to meet the requirements of 21 CFR 812.28 through other appropriate means." So it seems that either is recognized provided the CFR requirements are met. Also, ISO 14155 is an FDA consensus standard.

Also, Canada's Applications for Medical Device Investigational Testing Authorizations Guidance Document refers to ISO 14155, but makes no mention of ICH-GCP.

I also found this UL Whitepaper that suggests "While some differences remain between [ICH] GCP guidelines and ISO 14155 requirements...data collected through clinical investigations conducted in according with ISO 14155 is being more widely accepted by regulators as part of the medical device pre-market approval application process."

So the question remains, for anyone who can provide some clarity:
  • What is the substantive difference (if any) between ICH-GCP and ISO 14155?
  • When would you use one over the other? Is it as simple as ISO 14155 for medical devices, and ICH-GCP for drugs?
 

Watchcat

Trusted Information Resource
#5
Having worked on both sides, ICH grew up within pharma; ISO 14155 grew up within devices, in isolation from each other. However, since the fundamental principles of GCP are the same, they overlap a lot, just like the QSR and ISO 13485 overlap a lot, because the fundamentals of medical device quality systems are the same.

In the EU, the notified bodies will want to see compliance with ISO 14155. In the US, CDER and CBER will want to see compliance with ICH. I think CDRH is probably good with either one, because it was first exposed to ICH via CDER/CBER and then later to ISO 14155 via the EU. But you should confirm this.

PS FDA was always weak on GCP, apparently confusing "good" with "ethical," so it never came up with anything especially useful itself. The entire pharma industry heaved a sigh of relief when the ICH guideline was finally issued.
 
Last edited:

Watchcat

Trusted Information Resource
#6
but often there is just a reference to following "GCP"
Yeah, that's the clinical research crowd as I know it. GCP, like GMP, GLP, etc. is just a concept, having no tangible reality without a specified standard. You should be better able to understand this better than they do.
 
#7
Yeah, that's the clinical research crowd as I know it. GCP, like GMP, GLP, etc. is just a concept, having no tangible reality without a specified standard. You should be better able to understand this better than they do.
Hello,
Do we need to comply with ISO 14155:2020 if we are doing Cilnical trials for Artifical intelligence enabled software? or is there any other standard I should refer to? Please guide.
 

Watchcat

Trusted Information Resource
#8
Hello,
Do we need to comply with ISO 14155:2020 if we are doing Cilnical trials for Artifical intelligence enabled software? or is there any other standard I should refer to? Please guide.
As far as I know, yes, 14155 is applicable to any trial that you want to use to support conformity, regardless of the type of medical device, including software devices. But software devices per se, especially as regulated by the EU, are not my strong suit.
 

akp060

Involved In Discussions
#9
Hello,
Do we need to comply with ISO 14155:2020 if we are doing Cilnical trials for Artifical intelligence enabled software? or is there any other standard I should refer to? Please guide.

Doing some Googling/Reading online, and am finding myself a bit confused as to references to "Good Clinical Practice (GCP)".

Sometimes a standard is specified (ISO 14155), sometimes the International Conference on Harmonisation (ICH) is referenced, but often there is just a reference to following "GCP".

So, question: What is the effective difference between GCP (ISO 14155), and GCP (ICH)?

If I'm considering study protocols, is there reason to reference one over the other?
I've read that ISO 14155 has been updated for closer alignment to ICH-GCP, which seems to indicate there is a fair degree of overlap....

Any insight, or reading links much appreciated!
MM

According to my understanding, it depends on the product, 14155 for medical devices including software and ICH for drugs. When it comes what regulatory bodies look into both are involved, the latter from a concept standpoint in a reference capacity for devices (I can't comment for drug products) for eg. statistical analysis.

What you need to consider depends on whether you are trying to design the entire trial (for any medical device) by yourself. If yes, then you will
have to reference a lot and go back and forth a lot eg. you will have to reference ICH-GCP E9 for a statistical analysis plan.

Please remember GCP is what you practice, w.r.t design, conduct, monitoring, documenting, reporting, subject recruitment etc., When it comes to EU/FDA you will need to consider country specific evaluations also
 
#10
According to my understanding, it depends on the product, 14155 for medical devices including software and ICH for drugs. When it comes what regulatory bodies look into both are involved, the latter from a concept standpoint in a reference capacity for devices (I can't comment for drug products) for eg. statistical analysis.

What you need to consider depends on whether you are trying to design the entire trial (for any medical device) by yourself. If yes, then you will
have to reference a lot and go back and forth a lot eg. you will have to reference ICH-GCP E9 for a statistical analysis plan.

Please remember GCP is what you practice, w.r.t design, conduct, monitoring, documenting, reporting, subject recruitment etc., When it comes to EU/FDA you will need to consider country specific evaluations also
Thank You for this information
 
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