Preferred Label : Amendment Impacts Participant's Safety or Rights Indicator;
NCIt related terms : Is this amendment likely to have a substantial impact on the safety or rights of the
participants?;
Alternative definition : ICH: An indication as to whether the amendment is likely to have a substantial impact
on the safety or rights of the participants.;
Codes from synonyms : ICH M11-Section Amendment Details;
Origin ID : C218698;
concept_is_in_subset
