Commentary on FDA, clinical trials, research ethics, GCP, drug safety, and FDA Warning Letters
FDA Warning Letters: How to Navigate FDA’s Website
One of the Many Exhibitors at the
ACRP Conference
FDA Warning Letters, and some thoughts on critical and creative thinking, conclude my reporting from the Global Conference for ACRP – the Association of Clinical Research Professionals – held last week at the Washington State Convention Center in Seattle. During the conference it became apparent that many people, including FDA employees, have a difficult time searching for Warning Letters on FDA’s website. The Warning Letter section is an absolute mess. So I thought I would provide a few simple search tips to help find Warning Letters for GCPs. Unfortunately cGMP Warning Letters are more difficult, but the tips still help. Then I would like to tell you about an interesting session I attended on critical and creative thinking.
When searching for FDA Warning Letters, the link is below, scroll down and choose to “Browse Warning Letters by SUBJECT.” You will be presented with the alphabet. Click on “C” and then scroll down past all the “cGMP” categories until you reach “Clinical Investigator” where you will find the majority of GCP Warning Letters.
Searching for FDA Warning Letters
They will be listed in alphabetical order. There is a “Sort by:” option. Choose “Letter issued DESC” from the drop down menu. You will then have most of the GCP Warning Letters with the most recent listed first. You can also choose as subjects: Clinical Investigator – Sponsor; Bioresearch Monitoring; IRBs; Sponsor Obligations; and “IDE….” for medical device Warning Letters. There are several ways of listing for each category. You can sort by “Letter Issued DESC” for each category. There are five GLP categories plus Good Laboratory Practices. Go figure.
There were a number of interesting sessions that I attended at the ACRP meeting. I wanted to tell you about Critical Thinking in a Regulated Environment, because it can be so darn difficult. Kirk Mousley described critical thinking as producing ideas and then evaluating ideas. Citing Iris Verdi he described creative thinking as original, imaginative, and uncommon. He discussed that creative thinking comes through different avenues: it is often a revisement of something that already exists (evolution); a combination of two or more ideas (synthesis); or just a different way of looking at things, asking yourself, “how else can I look at this?”
How Can I Look at This Differently?
Mousley also discussed the barriers to creative thinking including “not part of an approved process” (SOPs). He noted that the regulatory process itself discourages critical thinking by imposing a “process mentality.” He countered that by suggesting that you build into a process the encouragement of critical thinking. And he pointed out the myth that “every problem can only have one solution or one right answer.” One of the points that I emphasize when doing a root cause analysis of a problem identified during a CAPA process is that you should Always Look for More Than One Root Cause.
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This entry was posted on Tuesday, May 10th, 2011 at 12:21 PM and is filed under Warning Letters. You can follow any responses to this entry through the RSS 2.0 feed.
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One Response to FDA Warning Letters: How to Navigate FDA’s Website
Carl,
Both critical thinking and creative problem solving have never been more important.
In highly regulated environments it’s all too easy to get boxed in and stuck in, for want of a better expression, one set of mental tramlines.
Much work is under way in relation to teaching critical thinking to medical students such as Ed Krupat at Harvard or, in the setting or the ER, Pat Croskerry at Dalhousie University in Canada.
I think it is an excellent rule of thumb to always challenge ourselves to think of more than one alternative when formulating CAPAs.
In a clinical research setting I think it is fair to say that critical thinkers can be identified as those professionals who:
Avoid reaching premature conclusions
See inconsistencies in information
Use knowledge more extensively and explicitly to make decisions
Are aware of their limitations and doubts
Monitor and evaluate their own decisions
Involve people more fully
Provide people with options
………I’ve swiped these ideas from something I read but have not got the reference to hand at present.
And creative problem solving, like learning, has much to do with constant curiosity and forgiveness for when things go wrong……..perhaps this is why it’s much easier for children!
GxP Perspectives 
Carl,
Both critical thinking and creative problem solving have never been more important.
In highly regulated environments it’s all too easy to get boxed in and stuck in, for want of a better expression, one set of mental tramlines.
Much work is under way in relation to teaching critical thinking to medical students such as Ed Krupat at Harvard or, in the setting or the ER, Pat Croskerry at Dalhousie University in Canada.
I think it is an excellent rule of thumb to always challenge ourselves to think of more than one alternative when formulating CAPAs.
In a clinical research setting I think it is fair to say that critical thinkers can be identified as those professionals who:
Avoid reaching premature conclusions
See inconsistencies in information
Use knowledge more extensively and explicitly to make decisions
Are aware of their limitations and doubts
Monitor and evaluate their own decisions
Involve people more fully
Provide people with options
………I’ve swiped these ideas from something I read but have not got the reference to hand at present.
And creative problem solving, like learning, has much to do with constant curiosity and forgiveness for when things go wrong……..perhaps this is why it’s much easier for children!