Clinical reports for Qtern - Initial marketing authorisation
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The protocol and protocol amendments, sample case report form and documentation of statistical methods are incorporated in the documents under 'Clinical Study Report'.
The clinical overview provides a critical analysis of the clinical data in the eCTD.
The clinical summary provides a detailed factual summary of the clinical information in the eCTD.
A clinical study report (CSR) on a clinical trial is a detailed document about the methods and results of a trial.
The anonymisation report describes the anonymisation process followed by the Applicant.