Conformance Rules Tab
- Provides a framework that allows you to configure conformance rules (validations against the ICSR reporting profiles: ICH, EMA, eVAERS and PMDA) based on the individual E2B (R3) Profiles.
- You can configure parameters for each ICSR Element Node for which data is transmitted.
- The Conformance Rules tab data is copied to the new profile when you copy any existing ICSR profile.
- The following table list the fields available in the Conformance Rules
tab:
Table 1-6 Fields in the Conformance Rules tab
# Field Name Type Description 1
Field Name/ Field Name (J)
Textbox
Enter the Field Name or Label of the Case Form or Console UI corresponding to the element's mapping logic.
- ICH, EMA, and eVAERS: English
- PMDA: Japanese
- PMDA E2B R3: See Mapping xls'Mapping(Sheet) > UI Field Name(J)
2
Field Location
Textbox
Enter the Case Form or Console UI field location or path corresponding to the element's mapping logic.
- ICH, EMA, and eVAERS: English
- PMDA: Japanese
- PMDA E2B R3: See Mapping xls'Mapping(Sheet) > UI Field Name(J)
3
Data Type
Drop Down
Select from the following options:
- <blank> (Default)
- Text
- E2B Code
- Country
- Date/Time
- MedDRA Version
- MedDRA Term/Code
- PMDA E2B R3: See Mapping xls > Mapping(Sheet) > PMDA Data Type DTD R3
4
Data Length
Textbox
Enter a numeric value.For PMDA E2B R3: See Mapping xls > Mapping(Sheet) > PMDA Length DTD R3
5
Mandatory Along with
Dropdown
Select a DTD_ELEMENT name from the list of all the elements available from the same parent of the selected element (except the selected element itself). Default value is <blank>.
For PMDA E2B R3: See Mapping xls > Mapping(Sheet) > Mandatory Along with
6
Allowed Value Check Required
Checkbox
Unchecked by default.For PMDA E2B (R3): See Mapping xls > Mapping(Sheet) > Allowed Values
7
Allowed Values
Button
On Clicking this button, "Allowed value configuration" dialog box appears to configuring the allowed values for the selected elements for that profile.
This button is enabled only if "Allowed Value Check Required" checkbox is selected.
For PMDA E2B (R3): See Mapping xls > Mapping(Sheet) > Allowed Values
8
Primary Validation Category
Drop Down
This option is available only for ICH, EMA, and eVAERS profile.This drop-down list has the values:
- <blank> (Default)
- Mandatory
- Conditional Mandatory
- Optional
- Other Fatal Validation
- Do not enter
9
Additional Validations
Button
On clicking this button, the "Additional Validation Configuration" dialog box appears that enables you to configure the SQL based validations for the element.This button is available only for ICH, EMA, and eVAERS.
10.1-10.4
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See separate table below
11
Save
Button
On clicking the save button the changes are committed to the database and the audit logs.
Saving the data also includes any changes done in the Allowed Value Configuration and Additional Validation Configuration dialog boxes.
It also validates if a Primary category exists for the ICSR element.
- For Non-PMDA profile: Element Level
- For PMDA profile: Reporting Category Level
If there exists a row with primary category as blank, an error message is displayed:
"Please select a Primary Validation category for the element" Title: "ICSR Validation"
12
Print
Button
On clicking the print button, entire Conformance Rule tab data is printed.
Table 1-7 PMDA Specific Fields in the Conformance Rules tab
# Field Name Type Description 10.1
Reporting Category
Label
This field represents a drop-down list containing Reporting Category LM. This is a mandatory field.
Determines the report being created (ADR, Infection, Research, or Measures in foreign countries). The list values are determined at run time by the values selected in items 9,10, and 12.
When Reporting Category is not selected, the license does not create the report.All the Reporting Category (R3) Codes (AA,AB,AC,AD,AE,AF,AG,DA,DB,DC,DD,DE,DF,DG,BC,BD) as configured in the Reporting Category (flex code list) are listed here, along with Nullification.
10.2
Reporting Category Description
Label
Describes the corresponding Reporting Category.
10.3
Primary Validation Category
Drop Down
This dropdown is available for PMDA profile only.
This field has the values:
- <blank> (Default)
- Mandatory
- Conditional Mandatory
- Mandatory for Completion Report
- Conditional Mandatory for Completion Report
- Optional
- Do not Enter
- Other Fatal Validation
For PMDA E2B (R3): See Mapping xls > Mapping(Sheet) > Reporting Category wise Conformance
10.4
Additional Validations Button
On clicking this button, the "Additional Validation Configuration" dialog box appears that enables you to configure the SQL based validations for the element.
This button is available against each Reporting Category.
Parent topic: Case Form