Transcription of IRTベンダー使用IRT用語 ISPE IRT WG推奨 説明 英語（原文） …
1 IRT randomization 2020 10 8 . IRT IRT ISPE IRT WG . No.. 1 Screening Screening .. 2 Screening Failure Screening Failure .. 3 Screening Failure Rate Screening Failure Rate .. 4 Enrollment Enrollment .. 5 randomization randomization .. randomization Code . 6 randomization Code . Key code .. 7 randomization List randomization List .. ID: Identification . Kit Number/ID . 8 Kit Number . Study Drug Number/ID .. 9 Randomisation Number randomization Number .. 10 Forced randomization Forced randomization . IRT .. 11 Screening Cap Screening Cap .. 12 Enrollment Cap Enrollment Cap .. 13 randomization Cap randomization Cap .. 14 Enrollment Date Enrollment Date / .. / . Visit . 15 Visit . Study Visit .. 16 Visit Date Visit Date .. 17 Unscheduled Visit Unscheduled Visit .. 18 Non Dispensing Visit Non Dispensing Visit . 19 Dispensing Visit Dispensing Visit .. 20 Treatment Complete Treatment Complate.
2 Drop Out . 21 Dropped oOut Drop Out .. Discontinuation . Visit Window . 22 Visit Window . Visit aAllowance .. Patient P . Subject . S S .. FPI/ (First Patient In). / FPI FSI FPI FSI/ First Patient (Subject) In 23 FSI (First Subject In) FPI/FSI. FPI/FSI FPFV FSFV/ Fitst Patient (Subject) Fitst Visit LPI LSI/ Last Patient (Subject) In LPD LSD/ Last Patient (Subject) Dispensation LPO LSO/ Last Patient (Subject) Out LPLV LSLV/ Last Patient (Subject) Last Visit IRT randomization 2020 10 8 . IRT IRT ISPE IRT WG . No.. 24 Transfer Transfer .. 25 Stratum / Stratum / .. 26 Stratification Factors Stratification Factors .. Adaptive Trial Design .. 27 Adaptive Adaptive Trial Design .. Randomizations . Dynamic Allocation/ . 28 Dynamic Allocation . Dynamic randomization .. 29 Static Allocation Static Allocation .. Treatment Groups 30 Treatment Groups . Treatment Arms . 31 Cohort Cohort.
3 32 Block Size Block Size .. Blind/Blinding/Blinded . 33 / Blinding . Masking/Masked .. Unblind/Unblinding/. 34 Unblinding . Unblinded / . Code Break . 35 Key Code Breaking Code Break . Key Open /.
