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 JPRN (Japan), TrialScope Disclose includes the following rules:
Assess if Protocol Registration is needed on JPRN (Japan)
Initial Protocol Law Due Date on JPRN (Japan)
Assessments
Assess if Protocol Registration is needed on JPRN (Japan)
Automatically assess Protocol Registration for JPRN for interventional trials conducted in Japan that have started on or after June 1, 2005.
Compliance Events & Due Dates
Initial Protocol Law Due Date on JPRN (Japan)
JPRN (Japan) Protocol Registration is assessed, disclosure needs to be posted on JPRN 1 day prior to study start date.
Protocol Disclosure Due date for “Law” will be set to Study Start Date – 1 Day.