[IEEE-bhpjobs] Fwd: eSource Data Interchange (eSDI) Document-V1.0 Posted

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-----Original Message-----
From: Sheila Camhi [mailto:news at cdisc.org]
Sent: Wednesday, November 29, 2006 10:07 AM
To: esther-l at mailsnare.net
Subject: eSource Data Interchange (eSDI) Document-V1.0 Posted



eSource Data Interchange (eSDI) Document-Version 1.0 Posted


Purpose of eSDI Initiative



The CDISC eSource Data Interchange initiative was 
originated to investigate the use of electronic 
technology in the context of existing regulations for 
the collection of eSource data in clinical trials for 
regulatory submission by leveraging the power of the 
CDISC standards, in particular the Operational Data 
Model (ODM).

Note: eSource pertains to eDiaries, ePatient 
Reported Outcomes (ePRO), eData Collection (EDC) 
Tools, Electronic Health Records (EHR)

The overarching goals are to make it easier for 
physicians to conduct clinical research, collecting 
data only once in an industry standard format for 
multiple downstream uses, and thereby to improve 
data quality and patient safety. 
* eSDI Group
* eSDI Document
* eSDI Posting

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* eSDI Group

The eSDI Group has representatives from academic 
research organizations, biopharmaceutical industry, 
contract research organizations, validation experts, 
and technology providers. 
Five FDA liaisons also 
worked with the Group.



~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
* eSDI Document

The product, a Version 1.0 document, has now been 
through 7 various review cycles, including the CDISC 
Board, the Industry Advisory Board and the public at 
large. Well over 700 comments have been received 
and addressed.

The eSDI Documents includes:
 


* An extensive review and analysis of the relevant 
existing regulations 

* Twelve requirements for conducting regulated 
clinical research using eSource data collection in the 
context of existing regulations

* Five potential scenarios, three of which include 
the use of electronic health record systems (EHR), 
and associated benefits standards

* An Appendix on Responsibilities of each of the 
various functional groups conducting clinical 
research

* A Template for evaluating an eSource data 
collection process against the requirements

* A Good Practices Checklist for Investigators




~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
* eSDI Posting

The document is posted on the CDISC 
website (http://rs6.net/tn.jsp?t=cxagk9bab.0.6llkvrbab.btzkurbab.893&ts=S0211&p=http%3A%2F%2Fwww.cdisc.org%2Fpublications%2Findex.html). 

A complementary document developed by PhRMA and 
the eClinical Forum can be found at here (http://rs6.net/tn.jsp?t=cxagk9bab.0.xijmh9bab.btzkurbab.893&ts=S0211&p=http%3A%2F%2Fwww.cdisc.org%2Fpdf%2FFuture%2520EHR-CR%2520Environment%2520Version%25201.pdf).



~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
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