Part 3: Elements scored regarding tumourigenicity studies
Availability in vivo study (no, yes); Reason for absence of the study (not necessary, planned, requested, not necessary but justification required, not mentioned); Species used (specified); Animal model used (healthy, disease model, immune-compromised); Survival product in animal (no, yes, not mentioned); Control group (no, yes, not mentioned); Sample size (specified); Cell dose (specified); Route of Administration (RoA, specified); Duration of the study (specified); Tumor formation (no, yes of human origin, yes of animal origin, unknown); ); Relevance (no, yes); Available In vitro studies (no, yes, requested, not mentioned); Method in vitro study (specified); In vivo and In vitro present (only in vivo, only in vitro , both, neither performed, not mentioned); Literature on cell type/cell product (no, yes, requested); Informativeness total package (no, partially, yes, not discussed), Reason for regarded informative (specified)