Structure and Content of Clinical Study Reports
INTRODUCTION TO THE GUIDELINE
The objective of this guideline is to allow the compilation of a single core clinical
study report acceptable to all regulatory authorities of the ICH regions. The
regulatory...
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Structure and Content of Clinical Study Reports
INTRODUCTION TO THE GUIDELINE
The objective of this guideline is to allow the compilation of a single core clinical
study report acceptable to all regulatory authorities of the ICH regions. The
regulatory authority specific additions will consist of modules to be considered
as appendices, available upon request according to regional regulatory
requirements.
The clinical study report described in this guideline is an "integrated" full report
of an individual study of any therapeutic, prophylactic or diagnostic agent
(referred to herein as drug or treatment) conducted in patients, in which the
clinical and statistical description, presentations, and analyses are integrated
into a single report, incorporating tables and figures into the main text of the
report, or at the end of the text, and with appendices containing the protocol,
sample case report forms, investigator related information, information
related to the test drugs/investigation
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