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 RPCEC (Cuba), TrialScope Disclose includes the following rules:
Assess if Protocol Registration is needed on RPCEC (Cuba)
Initial Protocol Law Due Date on RPCEC (Cuba)
Assessments
Assess if Protocol Registration is needed on RPCEC (Cuba)
Automatically assess Protocol Registration on RPCEC for Interventional studies conducted in Cuba with a Study Start Date on or after June 1, 2007.
Compliance Events & Due Dates
Initial Protocol Law Due Date on RPCEC (Cuba)
RPCEC (Cuba) Protocol Registration is assessed. Studies conducted in Cuba must be posted on RPCEC 1 Day prior to Study Start Date.
Protocol Disclosure Due date for “Law” will be set to Study Start Date - 1 Day.