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K-Blog

Kit's observations, opinions and rants on the world of clinical data standards and quality.

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K-Blog | kestrelconsultants.blogspot.com Reviews
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Kit&#39;s observations, opinions and rants on the world of clinical data standards and quality.
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3 4 image quality
4 adequate quality
5 exemplary quality
6 limited quality
7 not adequate quality
8 5 overlapping elements
9 equipment failure/error
10 medical reason
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K-Blog | kestrelconsultants.blogspot.com Reviews

https://kestrelconsultants.blogspot.com

Kit&#39;s observations, opinions and rants on the world of clinical data standards and quality.

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1

K-Blog: New FDA Guidance Requires More Data for Every Trial

http://kestrelconsultants.blogspot.com/2010/01/new-fda-guidance-requires-more-data-for.html

Kit's observations, opinions and rants on the world of clinical data standards and quality. Thursday, January 21, 2010. New FDA Guidance Requires More Data for Every Trial. In July 2009, the FDA issued a new final guidance defining clinical trial design, data and analysis requirements for drug-induced liver injury, or DILI, cases in all drug and biologic agent clinical trials. Ann Arbor, Michigan, United States. View my complete profile. New FDA Guidance Requires More Data for Every Tria.

2

K-Blog: June 2009

http://kestrelconsultants.blogspot.com/2009_06_01_archive.html

Kit's observations, opinions and rants on the world of clinical data standards and quality. Sunday, June 7, 2009. An Industry Evolving. Or not. An updated version of the entry that was here can be found at http:/ www.clinpage.com/article/a deep process problem/C12. Links to this post. Subscribe to: Posts (Atom). Ann Arbor, Michigan, United States. View my complete profile. An Industry Evolving. Or not.

3

K-Blog: March 2008

http://kestrelconsultants.blogspot.com/2008_03_01_archive.html

Kit's observations, opinions and rants on the world of clinical data standards and quality. Thursday, March 20, 2008. The other day I heard the old song by The Who “Who Are You”. It has been a while, and I can’t follow most of the lyrics on the track, but it doesn’t really matter. What struck me, as I was thinking about our business, is “Who Are You? 8221; We each have a number of roles we play. So where can we turn? Maybe we have to make do with fragmentary data extrapolated from studies that don’...

4

K-Blog: Structuring Clinical Data: AE Seriousness Fields

http://kestrelconsultants.blogspot.com/2009/10/structuring-clinical-data-ae.html

Kit's observations, opinions and rants on the world of clinical data standards and quality. Sunday, October 18, 2009. Structuring Clinical Data: AE Seriousness Fields. Defining “AE Seriousness”. The US regulations and the ICH guidances are uncharacteristically clear about what constitutes a serious adverse event, and they are consistent with each other. The ICH definition of “Adverse Event” is. Requires in-patient hospitalization or prolongs hospitalization. SAEs must be reported promptly to the regulato...

5

K-Blog: October 2009

http://kestrelconsultants.blogspot.com/2009_10_01_archive.html

Kit's observations, opinions and rants on the world of clinical data standards and quality. Sunday, October 18, 2009. Structuring Clinical Data: AE Seriousness Fields. Defining “AE Seriousness”. The US regulations and the ICH guidances are uncharacteristically clear about what constitutes a serious adverse event, and they are consistent with each other. The ICH definition of “Adverse Event” is. Requires in-patient hospitalization or prolongs hospitalization. SAEs must be reported promptly to the regulato...

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K-Blog

Kit's observations, opinions and rants on the world of clinical data standards and quality. Thursday, May 19, 2016. Why Standardizing Common Data Elements is Not Enough. Using the same element for multiple purposes isn't always wise! Then this threatens the quality of the data and the conclusions drawn from them. The Case for CDEs. Many organizations are developing CDE libraries, from CDISC 2. To many parts of the US National Institutes of Health 3. The Challenges with CDEs. Reason test was not completed.

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