Comparison of ISO 14155 to FDA Good Clinical Practice

[MattJ02]

I am a bioengineering undergrad student and I am writing some clinical protocols. In order to do the project I need to get a handle on the international and USA GCP standards. I am in dire need of some sort of table or document that compares and contrasts ISO 14155 to GCP requirements that the FDA has set forth in 21 CFR 812, 50, 56, 54,820, etc. Does anybody know where I can find such a thing?

[Gert Sorensen]

Originally Posted by MattJ02

I am a bioengineering undergrad student and I am writing some clinical protocols. In order to do the project I need to get a handle on the international and USA GCP standards. I am in dire need of some sort of table or document that compares and contrasts ISO 14155 to GCP requirements that the FDA has set forth in 21 CFR 812, 50, 56, 54,820, etc. Does anybody know where I can find such a thing?

Is anybody able to help here?

[Ajit Basrur]

Originally Posted by Gert Sorensen

Is anybody able to help here?

Sorry Gert. I have no idea on this and will wait for some one to offer answers.

[Ajit Basrur]

any answers ?

[wrodnigg]

Do you have the standard?

Some more information on clinical data yu could find in the MedDev documents and in the documents of the GHTF Study Group 5.

~ghw

[Tim LAWTON]

I don't know of any exact table which may provide what you are looking for; but can I suggest that you go to the following website

"clinicaldeviceforum.com"

It is a very active forum specifically aimed specifically at those who manage clinical.

[El Capitan]

Hello my friend. Google this document: "Best of Both Worlds: SOPs for Device Trials In Europe" by Nancy Stark for comparison of ISO 14155 to ICH E6. E6 is the international GCP standard and is a Guideline in the USA, however it closely mirrors FDA's GCP regulations and FDA has stated E6 is in essential compliance with them. I could have sent you the direct link but this forum would not allow that due to SPAM considerations. I am a GCP consultant in the USA. Good luck!

[MIREGMGR]

My guess is that, given the usual timetables of collegiate studies, MattJ02 has completed whatever he was working on at the time of his original post.

However, threads like this one often are useful to others via search. Thus this comparison of US FDA GCP and US HHS GCP regulations might also be useful:

http://www.fda.gov/oc/gcp/comparison.html