News for India about CDISC and HL7 related Clinical Research Standards Educational Events

In 2008, CDISC is interested in assisting India to connect to relevant educational webinars and User Group conference calls; hold two overview events in India (Delhi and Mumbai) in May; and gather support for a CDISC Interchange Conference in Mumbai in the fall. Please consider becoming involved with CDISC in India for 2008!

CDISC Overviews and Update

CDISC will be sponsoring two 2-hour educational sessions in India, aimed to provide an overview of CDISC.

• Wednesday, 7 May (Delhi, India) at Jawaharlal Nehru University
• Thursday, 8 May (Mumbai, India) hosted by Cognizant

The presentations will cover:

Background and History of CDISC
Overview, Benefits and Adoption of CDISC Standards
Global Standards Activities and Collaborations, (e.g. Regulatory Authorities, ISO, HL7, WHO)
Q&A, Discussion and Next Steps for India

CDISC Interchange

The current plan is to have a CDISC Interchange event in Mumbai in the fall of 2008 (if there is sufficient support for this event).  Following is the draft outline.

Potential CDISC Interchanges, India and China
 September/October 2008
 “Improving Patient Safety and Clinical Research Through Standards”

1 day or 1.5 day event.  Content is being planned

• Introduction to CDISC Course – Half-day Overview 
• HL7-CDISC Workshop  – Half-day Overview of Linking Healthcare with Research through Standards
• Conference topics

NOTE:  An SDTM Course or other such Educational Course could potentially be added on the front or back end of these Outreach Events.  The SDTM Course is a 2 day course.

If you are interested in participating in the planning and/or execution of the above events, please contact Rebecca Kush (CEO CDISC) rkush@cdisc.org. (If there is sufficient interest and sponsorship, we will proceed to schedule and organize these Interchanges)

• If you are interested in participating in the planning and/or sponsorship ofa CDISC Education Interchange in Mumbai in late Sept/October send an email to rkush@cdisc.org to be on the planning list.
• If you are interested in attending the fall Interchange in Mumbai, please be sure your name is on the CDISC mailing list.

CDISC plans India Committee for standardizing clinical data
To read the full story click here http://www.expresspharmapulse.com/20050331/coverstory02.shtml

Inaugural CDISC India Interchange, 19-20 March 2005

Presentations:
An Update on the SDTM (pdf)
A Sneak Peak at the CDISC Protocol Representation Model (pdf)
Bioethics Activities in India under ICMR (pdf)
Global Implementation of CDISC SDS v3.1 Data Standards — A CRO Perspective (pdf)
CDISC — Centerwatch Research Project in North America, Japan, Latin America and Europe (pdf)
The Interoperability Solution: The Domain Space Analysis Model (pdf)
Implementation Implications of Data Standards in Clinical Trials (pdf)
Introduction to CDISC (pdf)
Use of CDISC Standards in an Enterprise Class Clinical Data Management System (pdf)
Standard for Exchange of Nonclinical Data (SEND) (pdf)