Join us for the next ESUG Event

ESUG TC EVENT on the 30th of September 2010

-- OPEN FOR REGISTRATION --

The English Speaking User Group (ESUG) Committee would like to invite you to our TC event on the30th of September 2010.

To enable us to plan for numbers (and to ensure we have enough phone lines) for this event you will need to register, please email Veronica.A.Martin@gsk.com (with your e-mail address) to sign up for this event by the 27th of September 2010.

Date of event :

Thursday 30th of September 2010

Time of event :

10:00 AM - 11:30 AM London Daylight Time

Event details :

30 min for topic 1 (followed by 10 min of Q&A)

30 min for topic 2 (followed by 10 min of Q&A)

Topic 1: Title: “CDISC SDTM Validation: How can we do it right? (general)”

Main Content:

• This is a talk about the importance of SDTM validation (or compliance), especially for FDA submission

• Briefly discusses the approach in the Business & Decision Life Sciences environment

Topic 2: “Traceability between SDTM and ADaM converted datasets”

Main Content:

• Currently, SDTM is mapped from the original collected datasets for FDA submissions

• When FDA request the analysis datasets from ADaM, the traceability issue arises because the converted analysis datasets were not based on the SDTM datasets

• Discusses a practical approach to ensure traceability so the statistical analysis will produce the same results

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