Re: FDA, CDER Data Standards Plan

Hi Susie and Scott,

 

This looks like an opportunity we can't miss. HCLS have a lot of
experience with Semantic Web to feed back to FDA in their work with the
CEDER standard plan. 

 

Kerstin and I are interested to contribute with our experience when HCLS
review the plan and provide feedback.

 

Cheers,

Bosse

_______________________________________________________

Bosse Andersson 

Clinical Information Science

AstraZeneca R&D Lund, S-221 87 Lund, Sweden

Tel: +46 46 33 76 21 Mobile: +46 709 13 16 21

E-mail: bo.h.andersson@astrazeneca.com
<mailto:bo.h.andersson@astrazeneca.com> 

 

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Hi Susie,
 
Thanks for identifying this unique opportunity to engage with the FDA
about data standards. I have re-pasted the URL's below for convenience
because I had trouble accessing the versions in your previous message.
I am printing the draft to locate specific issues where HCLS can
contribute comments and suggestions.
 
1. Federal Register, 17 June 2010, 75(116), 34452-34453,
http://edocket.access.gpo.gov/2010/pdf/2010-14637.pdf
2. FDA, CDER Data Standards Plan (Version 1.0), Posted online 17 June
2010, 
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmi
ssionRequirements/ElectronicSubmissions/UCM214120.pdf
 
Cheers,
Scott
 
 
On Mon, Jul 5, 2010 at 11:28 AM, Susie Stephens
<susie.steph...@gmail.com> wrote:
> The FDA is announcing the availability for public comment of the draft
> document entitled "CDER Data Standards Plan Version 1.0". The draft
plan
> outlines the general approach proposed for development of a
comprehensive
> data standards program in the Center for Drug Evaluation and Research
> (CDER). The draft plan identifies key objectives for a data standards
> program at CDER, processes to be developed to ensure successful use of
those
> standardized data, and a set of recommended projects beginning this
calendar
> year [1, 2].
> 
> Please let me know if you would be interested in contributing to
> HCLS reviewing the plan and providing feedback.
> 
> Cheers,

> Susie

 


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