Table 4.

Top 5 Topics in the 66 Procedural Sections Needing Revision in CTTI Survey and the Current Japanese (JP) Survey

Top 5 principles in CTTI survey	Rank in JP survey	Top 5 principles in JP survey	Rank in CTTI survey
5.18 Sponsor: Monitoring	2	4.8 Investigator: Informed Consent of Trial Subjects	7
8.3 Essential Documents: During the Clinical Conduct of the Trial	14	5.18 Sponsor: Monitoring	1
8.4 Essential Documents: After Completion of Termination of the Trial	33	3.2 IRB/IEC*: Composition, Functions and Operations	16
5.5 Sponsor: Trial Management, Data Handling, and Record Keeping	8	4.9 Investigator: Records and Reports	6
8.2 Essential Documents: Before the Clinical Phase of the Trial Commences	6	4.3 Investigator: Medical Care of Trial Subjects	39

*IRB/IEC, Institutional Review Board/Independent Ethics Committee