Division 7 Where applicable, additional supporting information shall at least include:

summaries of data;

an updated overall risk/benefit assessment;

possible consequences for subjects already included in the clinical trial;

possible consequences for the evaluation of the results;

documents which relate to any changes to the information provided to subjects or their legally designated representatives, the informed consent procedure, informed consent forms, information sheets, or to letters of invitation; and

a justification for the changes sought in the application for a substantial modification.