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 REEC (Spain), TrialScope Disclose includes the following rules:
Assess if Protocol Registration is needed on REEC (Spain)
Assess if Results are needed on REEC (Spain)
Initial Protocol Law Due Date on REEC (Spain)
Initial Results Law Due Date on REEC (Spain)
Assessments
Assess if Protocol Registration is needed on REEC (Spain)
Automatically assess Protocol Registration on REEC for Interventional studies conducted in Spain as well as for studies that have a Product Market Authorization in Spain with a Study Start Date on or after January 12, 2016.
Assess if Results are needed on REEC (Spain)
Automatically assess Results Disclosure on REEC for Interventional studies conducted in Spain as well as for studies that have a Product Market Authorization in Spain with a Study Start Date on or after January 12, 2016.
Compliance Events & Due Dates
Initial Protocol Law Due Date on REEC (Spain)
REEC (Spain) Protocol Registration is assessed. Studies conducted in the Spain must be posted on REEC 14 days after NCA Approval.
Protocol Disclosure Due date for “Law” will be set to NCA Approval Date + 14 Days.
Initial Results Law Due Date on REEC (Spain)
REEC (Spain) Protocol Registration is assessed. Studies conducted in the Spain must be posted on REEC one year after Study Completion.
Protocol Disclosure Due date for “Law” will be set to Study Completion Date + 1 year.