SUMMARY
TrialScope Disclose includes a set of standard Compliance due date rules that can be enabled/disabled which help customers comply with their obligation to disclose clinical trial information.
For Company, TrialScope Disclose includes the following rules:
Initial Core Disclosure Law Due Date on Company
Insurance Event Law Due date for insurance due within 30 days of request on Company
Initial Insurance Event Law Due Date for future study start date on Company
Initial Insurance Event Law Due Date for insurance request in the past on Company
Initial PLS Law Due Date on Company
Initial Study Synopsis Law Due Date on Company
Compliance Events & Due Dates
Initial Core Disclosure Law Due Date on Company
Studies that have been assessed to disclose for Protocol, require a protocol to be registered 30 days before the study start date.
Registration Due date will be set to Study Start Date - 30 Days.
Insurance Event Law Due date for insurance due within 30 days of request on Company
Studies that have been assessed for insurance require the insurance request to be submitted within 53 days of creation of insurance request.
Registration Due date will be set to Insurance Creation Date + 53 Days.
Initial Insurance Event Law Due Date for future study start date on Company
Studies that have been assessed for insurance require the insurance request to be submitted within 53 days of creation of insurance request. However, if the study start date is in the future from creation of request, then the due date will be set to (study start date - 30 days).
Registration Due date will be set to Study Start Date - 30 Days.
Initial Insurance Event Law Due Date for insurance request in the past on Company
Studies that have been assessed for insurance with a study start date in the past from the creation of the request require insurance to be submitted within 53 days of creation of insurance request.
Registration Due date will be set to Insurance Creation Date + 53 Days.
Initial PLS Law Due Date on Company
Studies that have been assessed to complete a plain language summary will have the completion due date of the request set to one year from study completion.
Registration Due date will be set to Study Completion Date + 1 year
Initial Study Synopsis Law Due Date on Company
Studies that have been assessed to complete a study synopsis consisting of results data outside of registry summary results formats, will have the completion due date of the synopsis set to one year from study completion.
Registration Due date will be set to Study Completion Date + 1 year