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 RNEC (Portugal), TrialScope Disclose includes the following rules:

Assess if Protocol Registration is needed on RNEC (Portugal)

Automatically assess Protocol Registration on RNEC for Interventional studies conducted in Portugal with Product Intervention of Device or Product Intervention of Drug; or Post Authorization Study Type of Safety or Post Authorization Study Type of Efficacy and Study Start Date on or after December 5, 2016.

Assess if Results are needed on RNEC (Portugal)

Automatically assess Results Disclosure on RNEC for Interventional studies conducted in Portugal as well as for studies that have a Product Market Authorization in Spain with a Study Start Date on or after December 5, 2016.

Initial Protocol Law Due Date on RNEC (Portugal)

RNEC (Portugal) Protocol Registration is assessed. Studies conducted in Portugal must be posted 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 RNEC (Portugal)

RNEC (Portugal) Protocol Registration is assessed. Studies conducted in Portugal must be posted on RNEC one year after Study Completion.

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