Eligibility criteria for a fast-track process [1] Early CT Yes No Paediatric oncology and hematology Yes, specify age range : No Rare disease Yes No [1] non-eligibility criteria (for information) especially: healthy volunteer, complex design, ATMP Clinical trial identification Title Sponsor EudraCT number CPP concerned (if identified) Protocol Date/version : Study documentation Last authorized by Name IMP [2] Submitted ANSM dosage, pharmaceutical Document Version & date Version & Date form (If applicable) Chemical Biological IMP1 IMPD (Quality) IB IMP2 IMPD (Quality) IB IMP3 IMPD (Quality) IB IMP4 SmPC [2] tested, comparator and placebo (Duplicate as necessary)
Eligibility criteria for a fast-track process [1] Early CT Yes No Paediatric oncology and hematology Yes, specify age range : No Rare disease Yes No [1] non-eligibility criteria (for information) especially: healthy volunteer, complex design, ATMP Clinical trial identification Title Sponsor EudraCT number CPP concerned (if identified) Protocol Date/version : Study documentation Name IMP [2] dosage, pharmaceutical form Chemical Biological Document Submitted Version & date Last authorized by ANSM Version & Date (If applicable) IMP1 IMPD (Quality) IB IMP2 IMPD (Quality) IB IMP3 IMPD (Quality) IB IMP4 SmPC [2] tested, comparator and placebo (Duplicate as necessary)