Geo-Affairs
11th September 2008, 02:51 PM
Hello Group – My first post,
I am not able to find any information on the web (FDA or general search) on this specific subject. I have to deal with a feasibility study that will begin soon, that is being converted from a NSR study to an Investigator lead study. I have heard it interchangeably called an Investigator Initiated study. I have no experience with this, so could someone shed some light on the subject. I did not realize this was even an option. The product in question is a class III device that requires full disclosure of all studies performed regardless of outcome, and I want to cover my bases.
From my understanding, an investigator lead study requires IRB approval, but it does not require "NSR" justification. This is where I am having trouble, and I don't want to upset FDA or set a bad tone when it comes time to submit. Also, there are no requirements regarding monitoring according to FDA regulations, whereby, they investigator need only follow the institutions SOPs. Therefore, it is not considered an FDA approved IDE study as would an IRB approved NSR study. Please correct me if I am wrong.
Basically, I am asking this forum, based on experience what are the legal implications (hurdles) or pitfalls when submitting this type of clinical results to the FDA? Is it really investigator initiated when the manufacturer/specification developer is involved? I realize and do not intend to use the data to support safety or efficacy in the PMA. Please help.
Thanks in advance,
George
I am not able to find any information on the web (FDA or general search) on this specific subject. I have to deal with a feasibility study that will begin soon, that is being converted from a NSR study to an Investigator lead study. I have heard it interchangeably called an Investigator Initiated study. I have no experience with this, so could someone shed some light on the subject. I did not realize this was even an option. The product in question is a class III device that requires full disclosure of all studies performed regardless of outcome, and I want to cover my bases.
From my understanding, an investigator lead study requires IRB approval, but it does not require "NSR" justification. This is where I am having trouble, and I don't want to upset FDA or set a bad tone when it comes time to submit. Also, there are no requirements regarding monitoring according to FDA regulations, whereby, they investigator need only follow the institutions SOPs. Therefore, it is not considered an FDA approved IDE study as would an IRB approved NSR study. Please correct me if I am wrong.
Basically, I am asking this forum, based on experience what are the legal implications (hurdles) or pitfalls when submitting this type of clinical results to the FDA? Is it really investigator initiated when the manufacturer/specification developer is involved? I realize and do not intend to use the data to support safety or efficacy in the PMA. Please help.
Thanks in advance,
George
