Spring Intro 2023

24/03/2023

Why is a trial rejected?

• Scientific rejection o lack of preclinical data, adequate non-clinical and clinical data on the study drug lacking, exclusion criterion not updated, risk for specific patient group, serious deficiencies in evaluability, study design not adequate • Regulatory rejection

o criteria for interrupting the trial missing, instead, reference was made to the sponsor's internal instruction, the adverse reaction report was incorrectly described, IB not in readable condition

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• Changes that may affect the safety of the subjects or their physical or mental integrity or that may change the scientific value of the study or are significant for some other reason. • For example: Substantial modification (SM) - changes made to the protocol

o Inclusion / exclusion criteria o addition or removal of tests o number of patients o treatment o statistical analysis

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