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 AGES (Austria), TrialScope Disclose includes the following rules:
Assess if Protocol Registration is needed on AGES (Austria) for non-interventional studies
Assess if Results are needed on AGES (Austria) for non-interventional studies
Initial Protocol Law Due Date on AGES (Austria)
Initial Results Law Due Date on AGES (Austria)
Assessments
Automatically assess if Protocol Registration is needed on AGES (Austria) for non-interventional studies
Non-interventional trials of medicinal products approved in Austria that have started on or after Jan 9, 2010 will be automatically assessed to disclose Protocol.
Automatically assess if Results are needed on AGES (Austria) for non-interventional studies
Non-interventional trials of medicinal products approved in Austria that have started on or after Jan 9, 2010, will be automatically assessed for results disclosure.
Compliance Events & Due Dates
Initial Protocol Law Due Date on AGES (Austria)
Non-interventional trials of medicinal products approved in Austria that have started on or after Jan 9, 2010, require a protocol summary to be registered before the enrollment start date.
Registration Due date will be set to Study Start Date -1 Days.
Initial Results Law Due Date on AGES (Austria)
Non-interventional trials of medicinal products approved in Austria that have started on or after Jan 9, 2010, require summary results (typically a CSR Synopsis) to submitted within 12 months after study completion.
Results Disclosure Due date will be set to Study Completion Date + 12 months.