Preferred Label : Amendment Impacts Reliability and Robustness of Data Indicator;
NCIt related terms : Is this amendment likely to have a substantial impact on the reliability and robustness
of the data generated in the clinical trial?;
Alternative definition : ICH: An indication as to whether the amendment likely to have a substantial impact
on the reliability and robustness of the data generated in the clinical trial.;
Codes from synonyms : ICH M11-Section Amendment Details;
Origin ID : C218700;
concept_is_in_subset