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
For EU PAS/ENCEPP, TrialScope Disclose includes the following rules:
Assess if Protocol Registration is needed on EU PAS (EU) for non-interventional studies
Assess if Results are needed on EU PAS (EU) for non-interventional studies
Initial Protocol Law Due Date on EU PAS (EU)
Initial Results Law Due Date on EU PAS (EU)
Assessments
Assess if Protocol Registration is needed on EU PAS (EU) for non-interventional studies
Post Authorization studies of products approved in the EU that have started on or after July 2, 2012, whether conducted pursuant to an obligation imposed by an EU competent authority or voluntarily will be automatically assessed to register on EU PAS (ENCePP),
Assess if Results are needed on EU PAS (EU) for non-interventional studies
Post Authorization studies of products approved in the EU that have started on or after July 2, 2012, whether conducted pursuant to an obligation imposed by an EU competent authority or voluntarily will be automatically assessed to disclose results on EU PAS (ENCePP).
Compliance Events & Due Dates
ENCEPP Initial Protocol Law Due Date
The ENCEPP Protocol summary assessed to disclose for Post Authorization studies of products approved in the EU that have started on or after July 2, 2012 are due to be registered 1 day before the study start date.
Registration Due date for “Law” Compliance Due Date will be set to Study Start Date -1 Days.
ENCEPP Initial Results Law Due Date
ENCEPP Results assessed to disclose for Post Authorization studies of products approved in the EU that have started on or after July 2, 2012 must have results disclosed 12 months after Study Completion Date.
Results Disclosure Due date for “Law” Compliance Due Date will be set to Study Completion Date + 12 months.