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View Full Version : Comparison of ISO 14155 to FDA Good Clinical Practice MattJ02 22nd June 2007, 04:38 PM 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 25th June 2007, 02:35 AM 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 25th June 2007, 02:44 AM 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 14th July 2007, 08:18 AM any answers ? wrodnigg 9th August 2007, 06:18 AM Do you have the standard? Some more information on clinical data yu could find in the MedDev documents (http://ec.europa.eu/enterprise/medical_devices/meddev/index.htm) and in the documents of the GHTF Study Group 5 (http://www.ghtf.org/sg5/sg5.htm). ~ghw Tim LAWTON 8th September 2007, 02:24 AM 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 22nd November 2008, 04:23 PM Hello my friend. Google this document: "Best of Both Worlds: SOPs for Device Trials In Europe (http://www.devicelink.com/mddi/archive/07/07/008.html)" 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! :bigwave: MIREGMGR 22nd November 2008, 06:32 PM 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 MIREGMGR 24th November 2008, 06:30 PM This FDA page might be useful, too. http://www.fda.gov/oc/gcp/default.htm |
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