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 NMRR (Malaysia), TrialScope Disclose includes the following rules:
Assess if Protocol Registration is needed on NMRR (Malaysia)
Initial Protocol Law Due Date on NMRR (Malaysia)
Assessments
Assess if Protocol Registration is needed on NMRR (Malaysia)
Automatically assess Protocol Registration for NMRR for Interventional studies conducted in Malaysia that have started on or after January 1, 2006.
Compliance Events & Due Dates
Initial Protocol Law Due Date on NMRR (Malaysia)
NMRR (Malaysia) Protocol Registration is assessed, disclosure needs to be posted on NMRR 1 day prior to study start date.
Protocol Disclosure Due date for “Law” will be set to Study Start Date – 1 Day.