Define-XML

Define-XML files are an essential component of a CDISC data submission to the US FDA. In the Define-XML training course you will learn:

XML Essentials
Metadata for submission datasets
ODM-based XML for datasets
Analysis Results Metadata
How to manage Define-XML implementation challenges

Current Course Material Used:

Define-XML v2.0 Specification, ODM v1.3.2

Prerequisites:

Attendees should be familiar with the CDISC SDTM and ADaM specification and implementation guides. Prior XML experience is helpful but not required.

Course Length:

1 Day

Course Type:

Public, Private, Licensed

Audience:

Biostatistician

Data Manager

Programmer

Course Comments

"Very comprehensible. Instructor very willing to answer all my questions."
Public Course in Eschborn, Germany on 16 Jun 2016

"Learned essentials of Define-XML and had a glimpse of Dataset-XML as well."
Public Course in Toronto, Canada on 27 May 2016

"The instructor was very nice and easy to understand. It was a good training to have a first approach of define.xml."
Public Course in Paris, France on 11 Mar 2016

"The instructor clearly has experience with Define files and she creates a friendly tone in the classroom which makes it possible for everyone to ask questions."
Private Course

"Instructor was very knowledgeable about both CDISC standards and the use of XML."
Private Training