Nonclinical toxicology study reports, pre-clinical safety profiles, fertility and embryo-fetal development study, PK data, PD data, treatment emergent AE’s, treatment related toxicity, safety summary, response summary, ICF/PIS, SUSAR, SAEs reports, CIOMs, investigator brochures, protocols and protocol amendments, case report forms, lab manuals, e-diary instructions, imaging guideline manuals, annual safety reports, initiation visits, medical monitor visits, sponsor audits.