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Oracle® Argus Safety BIP Aggregate Reporting User's Guide Release 8.0 E54664-01 |
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# A Report Parameters and their Definitions

The following is a list of parameters required for PBRER, PMAR, and DSUR.

Table A-1 Parameter List

Parameter Display Name | Related Argus Configuration | Possible Values | Parameter Description
--- | --- | --- | ---
Enterprise ID | - | All enterprises to which the user has access. | This parameter displays the values of all enterprises to which the user has access. Depending upon the enterprise value, the system filters the other parameter values and shows values corresponding to the selected enterprise only.
Report Configuration Name | Selected Periodic Configuration Name | All the aggregate report configurations to which the user has access. | The configuration name executes the associated inclusion criteria for case series generation. If Case Series Name is not selected, use this parameter by default for fetching the case series name for report generation.
Print As | Report Batch Printing-> Print As | Draft, Final, Internal, or Other. | Defines the mode of printing for the report. Selected value is printed as a watermark , except the Final mode. The possible values are Draft, Final, Interval, and Other. For the Final mode, a submission record is created in the Argus database. The value of 'Other' supported by Argus Safety application is not supported through BIP user interface. When running a report through the Argus Safety interface, you can still choose the Other option and provide a different watermark to print in the report.
Main Case Series Name | - | All main case series generated using aggregate report configurations.The user can view these case series. | Selects a case series for report generation. The system only displays the main case series that are available for report generation and to which the user has access.
Cumulative Case Series Name | - | All cumulative case series generated using aggregate report configurations. The user can view these case series. | Selects a case series for cumulative counts during report generation. The system displays cumulative case series that are available for aggregate report generation and to which the user has access. For correct results, you must only select related main case series and cumulative case series.
PBRER 6.2 Case Series Name | - | - | All PBRER 6.2 Case Series to which user has access that are generated in the system are available for selection.
Ad hoc Case List 1 | Line Listing Query Criteria | - | If a case series has already been generated through Argus, auto populate through the selected Configuration Name and provide an option to override the auto populated values. If case series has NOT been generated through Argus, use the configuration name to associate the attached line listing queries and generate the case series at run time. If Line Listing queries are not attached to any ad hoc section, that section is printed without any case data.
Ad hoc Case List 2 | Line Listing Query Criteria | - | If a case series has already been generated through Argus, auto populate through the selected Configuration Name and provide an option to override the auto populated values. If case series has NOT been generated through Argus, use the configuration name to associate the attached line listing queries and generate the case series at run time. If Line Listing queries are not attached to any ad hoc section, that section is printed without any case data.
Ad hoc Case List 3 | Line Listing Query Criteria | - | If a case series has already been generated through Argus, auto populate through the selected Configuration Name and provide an option to override the auto populated values. If case series has NOT been generated through Argus, use the configuration name to associate the attached line listing queries and generate the case series at run time. If Line Listing queries are not attached to any ad hoc section, that section is printed without any case data.
Ad hoc Case List 4 | Line Listing Query Criteria | - | If a case series has already been generated through Argus, auto populate through the selected Configuration Name and provide an option to override the auto populated values. If case series has NOT been generated through Argus, use the configuration name to associate the attached line listing queries and generate the case series at run time. If Line Listing queries are not attached to any ad hoc section, that section is printed without any case data.
Primary Reporting Destination | Selected Reporting Destinations | List of all the available reporting destinations from LM_REGULATORY_CONTACT.AGENCY_NAME where deleted is NULL. | The submission record is added to the Argus database corresponding to the primary reporting destination. The system looks at primary destinations for a list of cases that were submitted during the previous reporting cycle. Note: When a report is marked as submitted for the primary reporting destination, the system provides an option to add the submission record for other configured destinations. This does not affect the BIP report. Only one destination can be selected as the primary destination while running the report.
Print Unblinded Data | - | Y/N | This parameter is applicable only if you can view unblinded data; otherwise blinded data is printed irrespective of the value of this parameter.
Default for NULL Values | - | - | This default value is populated in temp tables corresponding to any NULL values for specific set of fields.
Labeling Algorithm | - | 1. Use Case Assessment from Event Assess 2. Re-assess using datasheet at start date 3. Re-assess using datasheet at end date 4. Use Event Assess table with License List 5. Use Event Assess table with Report type + datasheets | The system provides five options for this parameter while running the report through BIP: Use Event Assess table with License List Use Case Assessment from Event Assess Re-assess using datasheet at start date Re-assess using datasheet at end date Use Event Assess table with Report type + datasheets: Lets you specify which Datasheet to look against for Listedness when running the report. When using the Event assessment from the case, the system considers only the As Determined listedness of the primary event or the case listedness from the case. When the ALL datasheet is selected, the system uses the most conservative listedness for the primary event, or the Case Listedness, for the report. When a datasheet is selected, the system uses the listedness against this datasheet for the report. The system calculates the Datasheet for Listedness on the Inclusion Criteria for ALL products within the case and not only for the first suspect drug.
Indicate if case was expedited previously | - | Y/N | Y: The system identifies expedited cases in the report and marks them with a symbol provided. N: No action required.
Symbol for expedited cases | - | - | A symbol to mark expedited cases in main line listing and tabulation summary reports.
Print only the Term (LLT or PT) | Line Listing-> Print Only the Term | Y/N | If N: Print verbatim along with PT or LLT as selected in other parameter. If Y: Print only PT or LLT as selected.
Print LLT instead of PT | Line Listing-> Print Only the Term (PT or LLT) | Yes/No | If No, print PT. If Yes, print LLT
Use Only Diagnosis Events | Line Listing->Event Reporting (CTPR) | Y/N | If Y Only Diagnosis events are populated in the temp table. If any value other than 1 or 0 is present in database, the system considers the event as diagnosis event.
Print Diagnosis Symptoms Separately | - | Y/N | If Y, the system prints the diagnosis and symptoms separately and marks them clearly using the symbol provided. If N, the system prints the diagnosis and symptoms without any identification symbol. Only applicable to summary tabulations.
Symbol for Symptoms | - | Symbol for identifying symptom | Identifies symptoms. If above parameter is N, nothing is printed for symbol.
Dosage String Format | - | Dose Dose,Formulation Dose,Formulation,Frequency Dose,Formulation,Frequency,Route Dose, Formulation,Route Dose,Frequency Dose, Route | Based on the value of combination of values selected, the system displays the dosage information in the report.
Include only HCP cases in summary tabulation | - | Y/N | If Y, the system includes only HCP cases in summary tabulation. If N, the system includes HCP and Non-HCP cases in summary tabulations.
Include follow-up cases from summary tabulations | - | Yes/No | If Yes, the system includes the follow-up cases also. If No, the system includes only initial cases in summary tabulations.
Exclude non-serious cases from summary tabulations | - | Y/N | Filter Criteria for Summary tabulation to exclude non-serious cases.
List cases in the line listing under SOC for each diagnosis | Line Listing-> List Cases only once, under the primary event, and List Cases under all events, details under the primary event | Y/N | If Y, the system prints other SOC as a reference. Otherwise, the system prints the details each time.
Log debugging messages | - | Y/N | -
Print identical events in line listing(Y/N)? | - | Y/N | The system compare PT code to identify matching events. If Y, the system prints all identical events. If N, the system prints the primary event. It prints the primary event or compare seq number or the event which appears first on Argus case form if primary event is not identical.
Print Dose Text in Place of regimen dose | Line Listing-> Print Dose Text in place of regimen dose | Y/N | -
Include Summary of Cases Missing Assessments | Summary Tabulations | Y/N | If this parameter is set to Y, the system displays the summary of cases missing assessment in report QA section.
Include Summary of Unlocked Cases | Summary Tabulations->Include Summary of Unlocked Cases | Y/N | If this parameter is set to Y, the system displays the summary of unlocked cases in report QA.
Report Title | Subject of Report-> Report Title | - | If this parameter is set to Y, the system displays the Report Title in the report. If this parameter is NULL, the system uses the report template Name.
Report # | Subject of Report-> Report # | - | If this parameter is set to Y, the system displays the Report # in the report cover page. If this parameter is NULL, the Report # is blank.
Report Footer | Subject of Report-> Report Footer | - | If this parameter is set to Y, the system displays the Report footer in the report. If this parameter is NULL, the system uses the default text.
UNIQUE_PATIENT_ID_FORMAT | - | Center, Patient Investigator, Patient Patient Study, Center, Investigator, Patient Study, Center, Patient Study, Country name ,Center, Investigator, Patient Study, Country name, Center, Patient Study, Country ISO Code, Center, Investigator, Patient Study, Country ISO code, Center, Patient Study, Investigator, Patient | Prints unique patient identifier based on following selections: Patient ID Center, Patient Investigator, Patient Study, Center, Investigator, Patient Study, Center, Patient Study, Country name, Center, Investigator, Patient Study, Country name, Center, Patient Study, Country ISO Code, Center, Investigator, Patient Study, Country ISO code, Center, Patient Study, Investigator, Patient.
Symbol for SUSAR Events | - | - | A hidden parameter with a default value of SUSAR that is printed with any SUSAR events in the case. You can update the report parameter list with another default value.
Symbol for Special Interest Events | - | - | A hidden parameter with the default value of †. The list of special Interest events can be configured on the periodic configuration screen on the Special Intereset AE tab.You can update the report parameter list with another default value.
Print As Other Text | Report Batch Printing-> Print As | - | When the Other Option is selected in Print As parameter, you can use this text box to enter the water mark text.
Clinical Drug Role Alogorithm | - | 1. Categorize based on Target Drug List 2. Categorize based on Product Type within the Study Configuration | For Algorithm 1: Use product list or target product list for categorization of case. For Algorithm 2: Use Study Configuration for categorization of case Based on the selected algorithm population logic of ClinicalDrugRole column of GTT_RPT_AGG_CASE is determined. This column is used in PBRER and DSUR report for categorizing a case under IMP, Blinded, Comparator and Placebo columns.
Print Serious Adverse Events or Reactions | - | 1. Print Serious Adverse Reactions 2. Print Serious Adverse Events | DSUR Cumulative tabulation and Main Line Listings either print the serious adverse events (SAE) or serious adverse reactions (SAR) based on the value of this report parameter.
Follow-up Algorithm | - | 1. Use Submission Tracking 2. User Timeframe (Initial Receipt Date) | Algorithm#1: 1. A case is categorized as follow-up if it has previously been submitted to the same regulatory agency and report form; otherwise it is categorized as initial. For cases that have been missed in the previous period, the same logic applies and those cases are marked as initial or follow-up based on the submission record. Algorithm#2: 1. A case that is a part of the case series is marked as Initial if the initial receipt date of that case falls into current reporting period; otherwise it is marked as follow-up. For cases that have been missed in the previous period, the same logic applies and those cases are assessed for initial receipt date only.
Persist data of Temp Tables | Argus Console->System Configuration->System Management (Common Profile Switches) -> Reporting->BIP Aggregate Reporting-> Persist data in BIP Aggregate Temp Tables | Yes/No | Yes: System persists or stores the data of BIP aggregate temp tables for selected case series used for aggregate reports generation. No: Data of BIP Aggregate Temp tables are not persisted for selected case series.
Number of Days for Data Persistence | Argus Console->System Configuration->System Management (Common Profile Switches) -> Reporting->BIP Aggregate Reporting-> Number of days for which data of BIP Aggregate Temp Tables are persisted. | - | Data of BIP Temp tables for selected case series is persisted for the number of days defined in this parameter. On completion of configured period (Number of days from the last modified date of selected case series), database/system job purges the data of this case series fro temp tables.