SUMMARY
TrialScope Disclose includes a set of standard assessment and due date rules that can be enabled/disabled which help customers comply with their obligation to disclose clinical trial information.
For JRCT (Japan), TrialScope Disclose includes the following rules:
Assess if Protocol Registration is needed on JRCT (Japan) for interventional studies
Assess if Results are needed on JRCT (Japan) for interventional studies
Initial Protocol Law Due Date on JRCT (Japan)
Initial Results Law Due Date on JRCT (Japan)
Assessments
Assess if Protocol Registration is needed on JRCT (Japan) for interventional studies
A study of interventional trials (including trials in healthy volunteers) that started on or after September 1, 2020, with one or more locations in Japan will be automatically assessed to be registered before the first patient is consented.
Assess if Results are needed on JRCT (Japan) for interventional studies
A study of interventional trials started on or after September 1, 2020, with one or more locations in Japan will be automatically assessed to require results to be registered within 12 months of study completion.
Compliance Events & Due Dates
Initial Protocol Law Due Date JRCT (Japan)
The Japan (JRCT) Protocol is assessed to disclose, therefore the study needs to be registered before the enrollment start date.
Initial Results Law Due Date on JRCT (Japan)
JRCT (Japan) Results are assessed, therefore results need to be posted to JAPIC within 12 months after study completion.