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DIA 2013 49th Annual Meeting
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Approaches to Risk-based Monitoring
Track : Track 01: Clinical Operations
Program Code: 265
Date: Tuesday, June 25, 2013
Time: 4:00 PM to 5:30 PM  EST
Location: 206AB
CHAIR :
 Jeffrey S. Handen, PhD (SCHNON), Vice President, Clinical Solutions, Medidata Solutions Worldwide, United States
SPEAKER (S):
 Ann Meeker-O'Connell, MS (SPKAGY), Senior Director, QA Clinical Strategy Team Lead, Janssen Pharmaceutica Inc., United States
 Vikas Gulati, (SPKNON), Director, Clinical Data Management, Vertex Pharmaceuticals, United States
Kyle Given, (SPKNON), Senior Vice President, Embedded Programs, Training and Quality Control, RPS, Inc., United States
Description
Ensuring data integrity and patient safety has been interpreted as 100% source document verification (SDV) and onsite monitoring. The 2011 FDA guidance, evidence of less than optimal accuracy of 100% SDV, and very low rates of data correction, all suggest alternate monitoring strategies.

Session Recording
(Code: 265)
DIA 2013 Attendee:
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This session is a part of:
DIA 2013 Live Learning Center
CON3 Comp Access: Tuesday Online Access Package - June 25, 2013
Handout Online
(Code: 265)
DIA 2013 Attendee:
Attendees Login
  
This session is a part of:
DIA 2013 Live Learning Center
CON3 Comp Access: Tuesday Online Access Package - June 25, 2013
Approaches to Risk-based Monitoring