28-A5
T&N Course  Bridging the Chasm—Paradigm Shift in Source Documentation for Clinical Trials

Monday, April 28, 2014: 2:15 PM-3:15 PM
Room 156ABC (Boston Convention and Exhibition Center)

Narrative Responses:

Synopsis & Educational Value
HELP! The sponsor wants it this way and the FDA says it should be that way. In reality, here is what I have to work with. So, how does it all fit together? With the use of computerized systems for health care and data capture in clinical investigations, it is common to find at least some source data recorded electronically. Course will highlight some of the challenges and benefits of both electronic data capture and paper source documentation, and will explore methods of bridging the gap.

Learning Objectives
Attendees will be able to define source documentation, describe various methods for capturing source data, and integrate paper and electronic source documentation.

Instructors:
Cynthia L. Callina, COMT, CCRC and Brandy J. Hunt, COA
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