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 CTRI (India), TrialScope Disclose includes the following rules:
Assess if Protocol Registration is needed on CTRI (India)
Initial Protocol Law Due Date on CTRI (India)
Assessments
Assess if Protocol Registration is needed on CTRI (India)
Automatically assess if protocol registration to CTRI is required for interventional trials and observational studies with one or more locations in India that have started on or after June 15, 2009.
Assessment include trials of drugs, biologics, medical devices, surgical interventions, behavioral treatments, traditional medicine as well as clinical studies conducted as part of a post-graduate thesis.
Compliance Events & Due Dates
Initial Protocol Law Due Date on CTRI (India)
CTRI (India) Protocol Registration is assessed, disclosure needs to be posted on CTRI 1 day prior to study start date.
Compliance Law Due date is one day prior to Study Start Date.