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 SUKL (Czech Republic), TrialScope Disclose includes the following rules:

Assess if Protocol Registration is needed on SUKL (Czech Republic)

Automatically assess Protocol Registration on SUKL for Observational studies conducted in Czech Republic with Post Authorization Study Type of Safety and Study Start Date on or after January 1, 2004.

Assess if Results are needed on SUKL (Czech Republic)

Automatically assess Results Disclosure on SUKL for Observational studies conducted in Czech Republic with Post Authorization Study Type of Safety and Study Completion Date on or after January 1, 2004.

Initial Protocol Law Due Date on SUKL (Czech Republic)

SUKL (Czech Republic) Protocol Registration is assessed. Studies conducted in Czech Republic must be posted on SUKL 60 Days for Study Start Date.

Protocol Disclosure Due date for “Law” will be set to Study Start Date – 60 Days.

Initial Results Law Due Date on SUKL (Czech Republic)

SUKL (Czech Republic) Protocol Registration is assessed. Studies conducted in Czech Republic must be posted on REEC one year after Study Completion.

Results Disclosure Due date for “Law” will be set to Study Completion Date + 1 year.