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 ChiCTR, TrialScope Disclose includes the following rules:

Assess if Protocol Registration is needed on ChiCTR (China)

Automatically assess if Protocol Registration is needed on ChiCTR (China) for interventional, non-phase 0 trials in the China region or Taiwan and study start date is after October 1, 2005.

Assess if Results are needed on ChiCTR (China)

Automatically assess if Results Disclosure is needed on ChiCTR (China) for interventional, non-phase 0 trials in the China region or Taiwan and study start date is after October 1, 2005.

Initial Protocol Law Due Date on ChiCTR (China)

ChiCTR (China) Protocol Registration is assessed, disclosure needs to be posted on ChiCTR 1 day prior to study start date.

Compliance Law Due date is one day prior to Study Start Date.

Initial Results Law Due Date on ChiCTR (China)

ChiCTR (China) Results Disclosure is assessed, results need to be posted on ChiCTR 1 year after Study Completion Date.

Compliance Law Due date is Study Completion Date + 1 year.