CDISC Panel Discussion

I have been invited to host and moderate a panel discussion at the next Western Users of SAS Software (WUSS) conference in San Jose. This will be in the CDISC section so we will be discussing meta data. I will share with you some general information about the discussion below.

Title
DEFINE.XML - A Practical Hands on Real World Experiences on Data Definition

Date Wednesday, September 2, 2009
Time 5:30-6:30pm
Where Fairmont San Jose in San Jose, California

Abstract
As CDISC guidelines nears becoming a regulation, it becomes apparent for the need of an effective method for documenting and communicating metadata to facilitate the review of clinical data during a submission. DEFINE.XML has proven in initial implementations and FDA pilot project to be an essential part in helping reviewers navigate data and related reports while also pointing out the needed improvements and challenges from implementing this in XML. This panel discussion will highlight real world examples of various approaches and shares lesson learned and innovative unique approaches. This includes technical techniques using SAS and processes and methodologies that spans any specific technologies.

Comments

Post a Comment

Popular posts from this blog

SASGF12 Opening Session with Jim Goodnight starting a technical demo ... nice :) Here is a video of it: http://ping.fm/sn6dY
Read more

Clinical Trials Terminology for SAS Programmers

Image
Introduction The drug development process is a clinical process that has its own language. It is not required that SAS programmers function as a MD or a regulatory expert, but working knowledge of the terminology is important to be effective. This section will walk through the drug development process from discovery to Phase IV. It will explain a wide range of acronyms such as IND, NDA , GCP and MedDRA . It will also describe some of the terminologies used within the process of clinical trials as a drug is developed and submitted to the FDA . This will give SAS programmers a larger perspective and context to their work during the analysis and reporting of clinical trials data. This section will tell a fictitious story about a college graduate named James who is starting a new position at a pharmaceutical company. Each new term James encounters is presented in bold and italicized for emphasis. As he enters a new professional world, he meets many people and learns new processes that
Read more

Remembering Dad

Meting Action Items Tom to decide if we should put spouse prefix (i.e. Wife or Husband) in front on name in Cao Pho. Two voted to include prefix and two voted to include Khanh to inform Jane (funeral coordinator) to keep dad's ashes in one urn Khanh to ask Jane and let Jackie know if and when to submit video for dad remembrance. Jackie will send backup of this video to Sy to place on iPad as backup Khanh to bring 2 six foot Fold out Table  Linh to get Ice Chest from Khanh and bring  Sy and Ha to bring 100 egg rolls Khanh to bring  Waters and Soda, Sparkling Water Jan to bring Fold out Chairs and space them out or elders spaced out (6 feet) Linh will also get four chairs from moms house Peter will also bring around 8 chairs Peter to bring and setup Popup Tent  Jan to bring Fruit which are individually packed Paul will bring Hand Sanitizer Tom and Yen to bring 50 Sandwiches and bagels Jan to make white headbands  Paul to send pictures of masks to verify if it matches headband, if so,
Read more