DIA 48th Annual Meeting
Click here to go to the previous page
Lessons Learned from FDA-sponsored ARRA PCOR (American Recovery and Reinvestment Act Patient Centered Outcomes Research) Data Standardization Efforts
Track
:
Track 07: Processes and Technologies for Clinical Research
Program Code:
224
Date:
Tuesday, June 26, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Crystal Allard, FDA, United States
PRESENTER
(S):
Amy Malla, FDA, United States Ted Peterson, FDA, United States
Lilliam Rosario, FDA, United States Helena Sviglin, FDA, United States
Description
FDA would like to share their experiences in standardization of data at each center. Each speaker will discuss the most valuable lessons they have learned during the conversion process including outstanding technical and policy issues.
Learning Objectives:
Discuss lessons learned while standardizing clinical data
Identify technical and policy issues that require follow-up
Discuss implications and impact of standardized data on FDA review and analytical utility Discuss specific examples of utility of standardized data across studies.
Learning Objectives:
Discuss lessons learned while standardizing clinical data
Identify technical and policy issues that require follow-up
Discuss implications and impact of standardized data on FDA review and analytical utility Discuss specific examples of utility of standardized data across studies.
This session is a part of:
Handout Online
