define.xml and SDTM

Define.xml is the document which specifies the standard for providing Case Report Tabulations Data Definitions in an XML format for submission to regulatory authorities (e.g., FDA). 

The XML schema used to define the expected structure for these XML files is based on an extension to the CDISC Operational Data Model (ODM).

In the picture below the key aspects are highlighted with the red text, basically it is a listing of data items that a sponsor will transmit to FDA along with the regulatory application.

Each data set if furthered detailed with what data items are sent and their nature (ex: Derived or from a CRF page)

You can find the DTD definition and stylesheets to transform define.xml on CDISC website : http://www.cdisc.org/models/def/v1.0/index.html

Drug Safety and Pharmacovigilance

The ground truth of how pharmaceutical industry has evolved over the past decade is the large surge in increased specialization and sophistication. In this series we will focus on specialist careers in pharmaceutical industry, lets start with pharmacovigilance.

No medicine which is effective is 100% safe, but the adverse/side effects of a drug have to be weighed against the benefits of the drug. For example a drug treating terminal disease like cancer can have some adverse effects like vomiting and hair loss, but still it would be approved given the gravity of disease it is used to treat. Drug safety function focuses on measurement, prediction, reporting and evaluating safety signals. There are several roles in this domain namely :

• Drug safety physician
• Safety specialist
• Safety informatics expert
• Safety information expert

If you are good at either synthesising medical information/research finding or have great analytical capabilities to drill down into complex safety data this area of specialization is very suitable and lucrative for you.