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 DRKS (Germany), TrialScope Disclose includes the following rules:
Assess if Protocol Registration is needed on DRKS (Germany)
Initial Protocol Law Due Date on DRKS (Germany)
Assessments
Assess if Protocol Registration is needed on DRKS (Germany)
Automatically assess if protocol registration to DRKS for interventional trials conducted in Germany that have started on or after October 1, 2003 .
The DRKS registry is a voluntary registry for interventional and observational trials for trials that have started on or after October 1, 2008.
Compliance Events & Due Dates
Initial Protocol Law Due Date on DRKS (Germany)
DRKS (Germany) Protocol Registration is assessed, disclosure needs to be posted on DRKS 1 day prior to study start date.
Compliance Law Due date is one day prior to Study Start Date.