DIA 48th Annual Meeting
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Update on Collaborative Projects of the Clinical Trials Transformation Initiative (CTTI)
Track
:
Track 01: Clinical Operations
Program Code:
217
Date:
Tuesday, June 26, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Jose Vega, Amgen Inc., United States
PRESENTER
(S):
Jose Vega, Amgen Inc., United States Patrick Archdeacon, FDA, United States
Cynthia Hahn, The Feinstein Institute for Medical Research, United States
Description
This session will present results of three Clinical Trials Transformation Initiative (CTTI) projects conducted by representatives of FDA, industry, academia, patients, and others: 1) Premarket Safety Management, 2) Central IRBs in Multicenter Trials, and 3) Site Metrics for Study Start-up.
Learning Objectives:
Describe current practices for assessing safety of a premarket product across all trials and for managing potential safety signals
Identify how to promote adoption of central IRBs in multicenter trials
Discuss how an organization can use industry-wide standard metrics for study start-up.
Learning Objectives:
Describe current practices for assessing safety of a premarket product across all trials and for managing potential safety signals
Identify how to promote adoption of central IRBs in multicenter trials
Discuss how an organization can use industry-wide standard metrics for study start-up.
This session is a part of:
Handout Online
