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 HKU CTR (Hong Kong), TrialScope Disclose includes the following rules:

Assess if Protocol Registration is needed on HKU CTR (Hong Kong)

Automatically assess Protocol Registration for HKU CTR for interventional trials conducted in Hong Kong that have started on or after June 1, 2005.

NOTE: Optional registration of protocols for trials with locations in Hong Kong that have started since June 1, 2005.

Assess if Results are needed on HKU CTR (Hong Kong)

Automatically assess Results for HKU CTR for interventional trials conducted in Hong Kong that have started on or after June 1, 2005.

Optional disclosure of results for trials with locations in Hong Kong that have started since June 1, 2005. Disclosure recommended within 12 months of study completion.

Initial Protocol Law Due Date on HKU CTR (Hong Kong)

HKU CTR (Hong Kong) Protocol Registration is assessed, disclosure needs to be posted on HKU CTR 1 day prior to study start date.

Protocol Disclosure Due date for “Law” will be set to Study Start Date – 1 Day.

Initial Results Law Due Date on HKU CTR (Hong Kong)

HKU CTR (Hong Kong) Results assessed to disclose. Results need to be posted on HKU CTR 1 year after Study Completion Date.

Results Disclosure Due date for “Law” will be set to Study Completion Date + 12 months.