Standard Time Table from Application to Completion of Clinical Trials

Time table for procedures

 
Procedure Gunma Univ. Shinshu Univ. Chiba Univ. Univ. of Tsukuba Tokyo Medical
& Dental Univ.
Univ. of Tokyo Niigata Univ. Univ. of Yamanashi
Application - IRB 12 14 15 13 15 15 14 21
IRB - Contract 1 7 1 17 7 0 1 14
Start-up meeting Completion of clinical trial 0 7 0 7 1 2 4 1
Report from PI to a directo r of hospital 1 7 0 6 1 1 2 1
Notification from a director of hospital to a sponsor 0 21 1 15 1 0 21 1

(days)

Timetable for safety reports

  Gunma Univ. Shinshu Univ. Chiba Univ. Univ. of Tsukuba Tokyo Medical
& Dental Univ.
Univ. of Tokyo Niigata Univ. Univ. of Yamanashi
Onset of SAE - IRB 1 14 1 1 1 1 1 1
Issue of official SAE report 1 7 1 2 4 1 1 7

(days)