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Protocol complexity, as measured by the number of unique procedures and their frequency and the number of subject eligibility criteria, has risen dramatically in comparisons of protocol characteristics between two time periods, 2000-2003 and 2004-2007.
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REGULATORY : Is It Safe to Outsource Safety? Waiving Inclusion/Exclusion Criteria CRO/SPONSOR : Metrics - The Pitfalls of Over Collection SUBJECT RECRUITMENT : Trial Results Provided to Volunteers in Pilot Program Also in this issue : New Reform Law Requires Fee Disclosure, GCP Standards in Global Trials, A Learning Healthcare System, The Physician Payments Sunshine Act
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