Configuring Expedited Report Rules
This section describes the configuration of Expedited Reports using pre-defined rules. These reports are required by Regulatory Authorities. The Administrator is responsible for entering information about Regulatory Authorities to which regulatory reports will be submitted.
This information is entered in the Regulatory Agency Information screen. Information about the local company contact for a regulatory authority can also be entered in this screen.
Configuration of the expedited report rules is done using the Business Configuration > Expedited Report Rules section.
When configuring expedited reporting rules, be aware of the following:
- If the user does not have permission to access Advanced Conditions on the
Expedited Reporting Rules, the system does the following:
- Displays the advanced condition name instead of displaying a blank.
- Does not permit the user to modify or view advanced condition details.
- Disables the Advance Condition button.
- The system enables the user configure the Blinding Study
Products option for those included in the case (default
unchecked).
- The system track updates to this field in the audit log.
- The Reporting Rules reports print the new options
- For cases where expedited reports are due, the user can force-distribute expedited reports even if processing is incomplete.
- Due Dates for expedited reports differ from Country to Country regulations. For
Group 1 countries, the Due Date is based on the Aware Date received globally for
the case.
For Group 2 countries, the Due Date is based on the Aware Date when the affiliate or a company representative of that country received information about the case. In that case, the Due date for these reports could be 15 days after the report was actually generated based on the aware date received globally.
When reports are scheduled and generated, the Due Date for Group 2 countries is calculated. The Due Date for a Group 2 Country = Report Generation Date + Additional days for Group 2 countries. The Due Date for a Group 2 country can be adjusted as per the holidays and weekends, through the Adjust Due Date for Group 2 countries by XXX days field.
- If two or more duplicate reports have different due dates (regardless of license type), the system schedules the report with the earliest due date.
- The reporting rules have a Force Distribute XXX days before
due checkbox. The default is unchecked.
- If the user checks the Force Distribute option, the # of days before due field is entered and automatically checks the Auto Distribute checkbox on the reporting rule (grayed out).
- The user can enter the number of days from 0 - # of days defined within the time frame.
- If the user enters a value greater than the defined time frame, the system displays the following message: Please enter a value less than the Time Frame defined for the Reporting Rule.
- If the user has not checked Force Distribute, the system disables the days before due.
- The system tracks updates made to the new Argus Console fields in the audit log.
- The system prints an audit log and print out that shows the expedited report rules information as shown in the following illustration.
- A super rule is a rule that overrides other rules when it finds a match. Be aware
of the following:
- The system executes a super rule before executing any other reporting rules.
- If a super rule matches, it executes all the super rules but does not execute other rules.
- If the super rule does not match, the application executes the other rules.
- When a user configures a Reporting Rule for MIR Report from
Console > Business Configuration > Expedited Reporting Rule, and the user selects MIR Report in the Form drop-down, the system will show the Message Type drop-down with Blank as a default value, and it will be disabled. - When a user configures a reporting rule report and selects PMDA Device Report in the Form drop-down menu, then the application populates the Message Type drop-down menu with ichicsr and disables the field.
For more information, see: