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 SNCTP (Switzerland), TrialScope Disclose includes the following rules:
Assess if Protocol Registration is needed on SNCTP (Switzerland) for interventional phase 1 studies
Assess if Protocol Registration is needed on SNCTP (Switzerland) for interventional phase 2-4 studies
Assess if Protocol Registration is needed on SNCTP (Switzerland) for legacy interventional phase 2-4 studies
Initial Protocol Law Due Date for phase 1 studies on SNCTP (Switzerland)
Initial Protocol Law Due Date for phase 2-4 studies on SNCTP (Switzerland)
Initial Protocol Law Due Date for legacy phase 2-4 studies on SNCTP (Switzerland)
Assessments
Assess if Protocol Registration is needed on SNCTP (Switzerland) for interventional phase 1 studies
Protocols for interventional Phase 1 studies with study start date on or after January 1, 2014 with locations in Switzerland are automatically assessed to be submitted to SNCTP.
Assess if Protocol Registration is needed on SNCTP (Switzerland) for interventional phase 2-4 studies
Protocols for interventional Phase 2, 3, or 4 with study start date on or after January 1, 2014 with locations in Switzerland are automatically assessed to be submitted to SNCTP.
Assess if Protocol Registration is needed on SNCTP (Switzerland) for legacy interventional phase 2-4 studies
Protocols for interventional trials Phases 2, 3, or 4 with a study start before January 1, 2014 that were ongoing as of January 1, 2015 with locations in Switzerland will be auto assessed to be registered on SNCTP no later than June 1, 2015.
Compliance Events & Due Dates
Initial Protocol Law Due Date for phase 1 studies on SNCTP (Switzerland)
The SNCTP (Switzerland) Protocol is assessed to YES for a phase 1 study, Therefore the study needs to be registered one year after the study completes.
Initial Protocol Law Due Date for Phase 2-4 studies on SNCTP (Switzerland)
The SNCTP (Switzerland) Protocol is assessed to YES for a phase 2-4 study. Study needs to be registered on SNCTP before the enrollment start date.
Compliance Law Due date is one day prior to Study Start Date.
Initial Protocol Law Due Date for legacy phase 2-4 studies on SNCTP (Switzerland)
The SNCTP (Switzerland) Protocol is assessed to YES for a legacy study. Study needs to be registered on SNCTP by June 1, 2015.