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 RNEC (Mexico), TrialScope Disclose includes the following rules:
Assess if Protocol Registration is needed on RNEC (Mexico)
Initial Protocol Law Due Date on RNEC (Mexico)
Assessments
Assess if Protocol Registration is needed on RNEC (Mexico)
Automatically assess Protocol Registration on RNEC for Interventional studies conducted in Mexico with a Study Start Date on or after January 1, 2013.
Compliance Events & Due Dates
Initial Protocol Law Due Date on RNEC (Mexico)
RNEC (Mexico) Protocol Registration is assessed. Studies conducted in the Mexico must be posted on RNEC 5 days after NCA Approval.
Protocol Disclosure Due date for “Law” will be set to NCA Approval Date + 5 Days.