That could be said of every request for information that is posted to this forum, which is to say, of virtually every post to this forum.
I don't see any need for someone to show evidence that they have done prior research on the question. That would be a waste of their time, pixels, and our time, unless it is necessary in order to clarify the question. Otherwise, just get to the question, please.
I do sometimes cringe when I see clear evidence that someone has not done their homework first, but there is no evidence that this is the case with this request.
Even so, I am also keenly aware that working RA professionals not infrequently find themselves in a situation where they need to make a temporary departure into an area that they normally do not work in, and therefore the amount of time needed to orient themselves to the area is not commensurate with the level of information or understanding that they need to get the job done. I see that as one situation in which this forum has high value to people whose goal it is to make good products available to the patients who need them as expeditiously as possible. If there is someone available to them that can easily point them to the information that they need, they would not be serving either patients or their employer well by spending their time on in-depth research and study of an area of the regulations that they otherwise have no reason to know, and don't expect to have any need to know again in the foreseeable future.
In this case, the request is simply for any information that someone can recommend, not a request for anyone to "find (or better yet determine) leads and many times full plans for them without demonstration of taking first steps, preliminary searching, planning, or narrowing of a scope, focus, or topic." If you have a problem with this types of requests, it would be more to the point to address them in response to one of these types of requests than to a request that is quite appropriate, IMO, and representative of the main purpose served by this Forum.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 21-Sep-2017 09:55
From: Anonymous Member
Subject: Research paper topic
This message was posted by a user wishing to remain anonymous
Being a graduate from the same program of which you speak- the point of these exercises is for the student to scrub the press releases, study the guidances, releases from the Agency's website and find how that is relevant to your topic. I fine it a bit presumptuous for a fair amount of students and "RAC-seekers" to constantly ask the working community to find (or better yet determine) leads and many times full plans for them without demonstration of taking first steps, preliminary searching, planning, or narrowing of a scope, focus, or topic.
Original Message:
Sent: 20-Sep-2017 20:15
From: Harsh Raja
Subject: Research paper topic
Hello,
I am currently pursuing Masters in Regulatory Affairs from Northeastern University. I am enrolled in a capstone project and I am in a search for topics related to Risk Management in QA/RA. If anyone could suggest any particular subject/topic/articles which is a recent issue or something which can be comprehensive enough to include in a capstone project that would be a great help.
Thank you
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Harsh Raja
Northeastern University
hkr21raja@gmail.com
(857)-928-6284
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