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 REPEC (Peru), TrialScope Disclose includes the following rules:
Assess if Protocol Registration is needed on REPEC (Peru)
Assess if Results are needed on REPEC (Peru) for interventional studies
Initial Protocol Law Due Date on REPEC (Peru)
Initial Results Law Due Date on REPEC (Peru)
Assessments
Assess if Protocol are needed on REPEC (Peru) for interventional studies
Interventional trials of medicinal products approved in Peru that have started on or after Jan 1, 2007 are automatically assessed to Disclose protocol on REPEC.
Assess if Results are needed on REPEC (Peru) for interventional studies
Interventional trials of medicinal products approved in Peru that have started on or after Jan 1, 2007 are automatically assessed to require a final study report (results) on REPEC.
Compliance Events & Due Dates
Initial Protocol Law Due Date REPEC (Peru)
REPEC (Peru) Protocol is assessed, disclosure needs to be posted to REPEC 1 day prior to study start date.
Initial Results Law Due Date REPEC (Peru)
REPEC (Peru) Results are assessed, results need to be posted to REPEC within 12 months after study completion.