Drug Industry Daily

June 25, 2012 | Vol. 11 No. 124

ICH Clarifies Issues With Old Clinical Study Reports Guidance

Trial sponsors should still include key documents that provide critical study information, such as the protocol and statistical methods, in the clinical study report (CSR) even though those documents are now available in the Trial Master File (TMF), according to a new question-and-answer document on the International Conference on Harmonisation (ICH) E3 guidance.

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