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 PPB (Kenya), TrialScope Disclose includes the following rules:
Assess if CTA is needed on PPB (Kenya) for interventional and expanded access studies
Initial CTA Law Due Date on PPB (Kenya)
Assess if CTA is needed on PPB (Kenya) for interventional and expanded access studies
Interventional and expanded access trials with a site(s) in Kenya that have started since October 1, 2014 will be automatically assessed to submit the CTA (Full Protocol, SAP, and protocol summary) to the Ministry of Health Pharmacy and Poison Board for approval.
Compliance Events & Due Dates
Initial CTA Law Due Date PPB (Kenya)
The Kenya (PPB) CTA has been assessed to disclose, the CTA (Full Protocol, SAP, and protocol summary) must be submitted to the Ministry of Health Pharmacy and Poison Board (PPB) for approval 30 days prior to study start date