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 JAPIC (Japan), TrialScope Disclose includes the following rules:
Assess if Protocol Registration is needed on JAPIC (Japan) for interventional phase 1 studies in healthy volunteers or observational studies
Assess if Protocol Registration is needed on JAPIC (Japan) for interventional phase 2-4 studies or phase 1 studies in patients
Assess if Results are needed on JAPIC (Japan) for interventional phase 2-4 studies or phase 1 studies in patients
Initial Protocol Law Due Date on JAPIC (Japan)
Initial Results Law Due Date on JAPIC (Japan)
Assessments
Assess if Protocol Registration is needed on JAPIC (Japan) for interventional phase 2-4 studies or phase 1 studies in patients
A study of interventional trials (excluding Phase 1 trials in healthy volunteers) started on or between March 28, 2018 and August 31, 2020, with one or more locations in Japan. Study is automatically assessed to disclose to be registered before the first patient is consented.
Assess if Protocol Registration is needed on JAPIC (Japan) for interventional phase 1 studies
Phase 1 trials in healthy volunteers or observational trials started on or between March 28, 2018 and August 31, 2020, with one or more locations in Japan will be automatically assessed to disclose to be registered before the first patient is consented.
Assess if Results are needed on JAPIC (Japan) for interventional phase 2-4 studies : phase 1 + Participants - New Rule
A study of interventional trials (excluding Phase 1 trials in healthy volunteers) started on or between March 28, 2018 and August 31, 2020, with one or more locations in Japan are required will be automatically assessed to disclose results.
Compliance Events & Due Dates
Initial Protocol Law Due Date JAPIC (Japan)
The Japan (JAPIC) (UK) Protocol is assessed to disclose, study needs to be registered one day prior Study Start date.
Initial Results Law Due Date on JAPIC (Japan)
Japan (JAPIC) (UK) Protocol is assessed to disclose, study needs disclose initial results 1 year after study completion date.
Initial Results Disclosure Due Date: Study Completion Date + 365 days