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Janet Athene Lane - Comment

Document ID: FDA-2011-D-0597-0008
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: October 12 2011, at 12:00 AM Eastern Daylight Time
Date Posted: November 14 2011, at 12:00 AM Eastern Standard Time
Comment Start Date: August 29 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: November 28 2011, at 11:59 PM Eastern Standard Time
Tracking Number: 80f50d1e
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We have conducted a systematic review of the published literature on on-site monitoring systems for clinical trials that would help inform this guidance. Presented at the SCT conference, abstract in Clinical Trials 2010 7:428, full paper under review at Clincial Trials. I can send this when accepted if you wish? we have just had referees comments and are revising the paper.

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