Transcription of ) JSCTR GCP (2018 年4月修正
1 JSCTR GCP ( ) JSCTR GCP (2018 8 ) 1 J-GCP J-GCP 2 3 Institution Investigator (Sponsor Certified Copy CRO:Contract ResearchOrganization SMO Site ManagementOrganization IRB IEC JSCTR GCP SOP.)
2 Standard Operating Procedure ADR Adverse Drug Reaction SAE SeriousAdverse Events Unexpected AdverseDrug Reaction 4 Phase Superiority Trial Crossover Trial Bioequivalence Trial JSCTR GCP true surrogate FAS ITT PPS) P 5 COI:Conflict of Interest CIOMS.
3 Council for InternationalOrganizations of Medical Science 6 IC IC 7 J-GCP ICH-GCP JSCTR GCP 8 Investigator Institution 9 SUSAR (Suspected Unexpected Serious AdverseReaction) 10 ICH-GCP ICH ICH ICH-GCP J-GCP 11 12 QC) QA) PDCA CAPA Corrective Action andPreventive Action13 FDA JSCTR GCP 14.
4 15 (COI; Conflict of Interest) 16 Essential documents ICH E6 8. Essential documents for the conduct of aclinical trial 17 PMDA 18. 19
