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Clinical Trials Advisor
July 19, 2012 | Vol. 17 No. 14
ICH Clarifies Issues With Old Clinical Study Reports Guidance
Trial sponsors should continue to include key documents with critical study information — such as protocol and statistical methods — in clinical study reports (CSR), even though those documents are now available in the trial master file (TMF), according to a question-and-answer document on the International Conference on Harmonisation’s (ICH) E3 guideline.
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