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)