Part 3: need for, type and design of invitro and in vivo
tumourigenicity studies
Available in vivo study, Reason for absence (not necessary,
planned, requested, not necessary but justification required, not
mentioned); Homologous model (not (known), yes, both homologous and
heterologous); Dose of 10^5; Dose of 10^6; Dose of 10^7, RoA
subcutaneous, RoA other (specified); Duration 0-3 months; Duration 3-6
months; Duration 6+ months; Presence Integration site analysis; Tumor
formation (no, yes of human origin, yes of animal origin, unknown);
Relevance (no, yes); Available In vitro studies (no, yes,
requested, not mentioned); Karyotyping; Colony formation/Proliferation;
Genomic analysis (transcriptional/epigenetic/SNP/microarray, telomere
length); Immortalization (IVIM, senescence, apoptosis); Other
(specified); In vivo and In vitro present (only in
vivo, only in vitro , both, neither performed, not mentioned);
Informativeness total package (no, partially, yes, not discussed),
Reason for regarded informative (specified)