The RRM Line Listing Report helps companies to know the timelines for initial and follow-up reporting of AERs to various Regulatory Authorities.
While generating the report, system will take into consideration, the conditions as specified in the Distribution/Submission List in ARISg Administrator module. For each defined combination of authority and country, ARISg will verify which condition the selected case corresponds to, and based on the specified reporting times, 'ARISg calculates the reporting time of this case for the Authority/Country combinations’. The report will be generated for the first condition that the case falls into. The conditions are set in Distribution/Submission List module of ARISg Administrator.
In ARISg, you can invoke the RRM Line Listing Report Selection page in two ways:
From the List of Selected AERs page or
From Reports à RRM Line Listing menu option in the main menu of ARISg.
The RRM line Listing Report Selection page appears.
Field Description for RRM Lines Listing Report Selection Criteria
Field Name |
Description |
Selection |
|
AER no. range |
Shows the range of the AER numbers. The report is generated for the specified AER records. |
Date range |
Shows the date range for the AERs. The report is generated for the AER records created in the specified period. |
Group by |
|
Recipients |
If selected, the AERs are grouped based on the contact person (recipient). |
AER/Version no. |
If selected, the AERs are grouped and printed based on the AER number. |
Exclude not reportable contacts |
Option is selected to print the cases, which has a reported date. |
Report Type |
|
Overdue |
Cases, which have not been reported but are overdue according to RRM due date calculation can be checked to print. The following cases are considered as Overdue:
If the contact type is specified as ”Authority” or is blank then the following cases hold good:
If the contact type is NOT specified neither as ”Authority” nor it is blank then the following cases hold good:
The following logic will be used to identify the distribution record:
|
Late |
This option is checked to print a list of reports that were submitted after the due date. The following case is considered as Late:
If the contact type is specified as ”Authority” or is blank then the following cases hold good:
If the contact type is NOT specified neither as ”Authority” nor it is blank then the following cases hold good:
The following logic will be used to identify the distribution record:
|
Discrepancy |
This option is checked to print information on the discrepancies found (for example, user decision was different from the system function). The case is reported as ”Discrepancy” when:
If the Informed Authority for the case matches with the Authority in Distribution/Submission maintenance , then the Reporting status and the Date reported are printed in the report irrespective of the ”Report type” and ”Reporting Status”. If the contact type is NOT specified neither as ”Authority” nor it is blank then the following case holds good:
The logic can be summarized, when the case is discrepant, then "Reporting Status” and ”Date Reported” will be blank. |
All |
This option is checked to print all the cases that meet the selection criteria. This is selected by default. |