Comparing and Reconciliation

ARISg application creates a follow-up for a case, when you have users working on the initial version of the same case in the workflow. After the follow-up case is created, the data entered in the initial version of the case is not available in the new version of the case. Compare and Reconcile option here enables you to copy the data from previous version, to the new version of the case.

NOTE: Before performing the following steps make sure you have privileges and update access to AER to reconcile AERs. Based on the settings in the Field Maintenance screen of the Admin application, the application displays the fields under E2B fields or Non E2B fields in the Compare and Reconcile screen.

The application supports the Blind or Unblind product by allowing you to copy from previous version to the new version of a case.

In the Record Level Differences screen, the Normal/Blinded/Unblinded records are displayed as separate links under Modules in the left pane, as follows:  

·         Suspect

·         Suspect Blinded

·         Suspect Unblinded

·         Vaccine given on same day Blinded

·         Vaccine given on same day Unblinded

Changing actions of Blinded and Unblinded Records

To change the actions of Blinded and Unblinded Records:

1.       Create a case 2017-000001-000010 .

2.       Select  2017-000001-000010 in the Workflow Status page.

3.       From the Others menu, click Compare and Reconcile option.
The Compare & Reconcile AER window appears displaying the versions available for the selected AER, except the latest version.

4.       Select 0.0 version.

5.       Click Compare.
The Record Level Differences screen appears displaying the Normal/Blinded/Unblinded records, which are displayed as separate links under Modules in the left pane.

6.   Click Suspect Blinded link.
The list of Blinded records are displayed under the context data field in the right pane.

7.   Select a Blinded record from the list.

8.       Click the cell under the Action column for the selected record.

9.       From the Action drop-down list, select Delete New Record or Mark as Deleted option.
The action of the corresponding Unblinded record is automatically changed as Delete New Record.

10.   If you change the action the Unblinded records, these AER - Web Page Dialog box appears displaying the message “No actions allowed when Mark as deleted/Delete new record selected for blinded record".

For performing any actions on unblinded records, change the action of Blinded record from Delete New records or Mark as Deleted to No Action, then the application automatically changes the action of corresponding Unblinded record to No Action.

Note: All the Unblinded records mapped with the Suspect blinded record are displayed when you click the  Suspect Unblinded link.  Similarly, all the Unblinded records corresponding to Vaccine given on same day blinded record are displayed when you click the Vaccine given on same day Unblinded link. Before performing any actions on any Unblinded record, ensure to map the corresponding Blinded record.

To Copy data from old version to the latest version of a case, perform the steps:

1.       Creating an Initial Version of a Case

2.       Creating a New Version of a Case

3.       Select the case from workflow to perform the compare and reconcile operation

4.       Displaying Record Level Differences

5.       Displaying Field Level Differences

Note: The Data Privacy module is supported in Compare and Reconcile module. The users having access privilege to Compare and Reconcile module can view the decrypted data displayed in the Compare and reconcile module for Data privacy fields.

Creating an Initial Version of a Case

1. Create a case AER-001
   The case is created based on the setting of Use local version scheme Installation parameter.
2. Select Forms >Full Data Entry >Product
3. Enter the Product description for  the following product flags:

• Suspect product -Painkiller
• Enter V1 for vaccine
• Enter Methyldopa as Concomitant product
• Enter Desprin and Aldomet as Premedications

4. Enter the Latest Received date

5. Save the case

Creating a New Version of a Case

1. Open the case AER-001 from the Workflow Status Page

2. Select CASE > New version

Note: The New version is made available only for the latest approved version of the case.

3. Enter the case data as follows:

• Enter Actos as Premedications
• Enter Septilin as Premedications

4. Enter the Latest Received date.

5. Save the case version 1.0 or 0.1 of the case is created.

Comparing AERs

1.       Select AER-001 in the Workflow Case

2.       Click Others menu to select Compare and Reconcile option.
Compare and Reconcile window appears displaying the versions available in the AER, except the latest version.

3.       Select 0.0 version.
The application displays Record level differences in the following modules:

§  Suspect product

§  Concomitant product

§  Premedications

§  Past

The application displays record Level differences only when there are differences between the two selected versions. The differences in tables "Authority”, "Document” etc are not shown in E2B Import.

Changing the Rank of Context Fields

When you change the rank of the fields the reordering impacts only the latest version of the case and not the earlier version of the case.

For Example:

To change the rank of the Actos field:

1.       Select Actions in the Latest Version.

2.       Click the Up arrow key    twice.

The application changes the current rank of Actos from  3  to 1.

Similarly you can rank the other products available in the latest version of the case. You can only rank the products that belong to the following type of Products:

§  Suspect Product

§  Concomitant product

§  Vaccine given on same day

§  Vaccine given prior 4 weeks

§  Premeditations

§  Current Reaction

§  Past Reaction

The context field in the application, display code  and decode value in the brackets. If  the data is too long, then double-click on the corresponding value to view the complete data.

Mapping of Context Fields

When the application has similar products in the old version and in the latest version but differ in their content in the context fields, then the application allows you to explicitly map the displayed versions.  Mapping helps you compare information and there by enables you to copy the information in the previous version to the latest version of the case.

When you are comparing two versions of a case, the application displays all the records in the Record Level Differences screen although there are no differences.

Blind and Unblind products of the previous version must be mapped and copied to the Blind and Unblind products respectively.

Note: You can de-associate and again map the records that are already mapped by the application in earlier versions of a case.

The application displays all the records of the context fields in the Record Level Differences screen even though same value is available in the context fields for both old and new versions.

To map:

1.       Open the latest version of the AER from the Workflow.
Example 1.0 version of AER-001

2.       Select Forms > Full Data Entry > Lab

3.       Change the existing Test name from HB to HB complete

4.       Save the case

5.       Compare the versions.
The application maps the selected products.

6.       When the fields are set as context fields in the Admin > SetUp > Database Structure Maintenance > Field Maintenance, the application displays the codelists values of the context fields in the Record Level Differences Screen.

Note: For Simple QC, mapping/unmapping of Simple QC records is not supported. By default the "Item” field is selected as "Context” field. Also, it is recommended not to change the Item field as context field. If you click "Map/Unmap” button, the application displays the message”Cannot map/unmap Simple QC Records”.

Unmapping of Context Fields

You can UnMap the context fields only if the fields are explicitly mapped.

1.       Select HB and HB complete

2.       Click Unmap.
The application Unmaps the fields.

Note: You can un-map the records that are already mapped by the application.

Performing Actions on each Record

The application enables you to apply an action to each record by selecting an option in the Action drop down. You can carry out actions on the corresponding record in the latest version. Actions in the Drop down box are as follows:

§  No Action (default)

§  Delete New Record

§  Copy Old Record

§  Copy Old Record (incl Child)

§  Mark as Deleted

To perform an action:

1.       Select a record

2.       Select an Action from the drop down

3.       Click Continue.
Field Level Differences screen appears.

4.       Make the required changes in the Field Level screen. (Refer to the section Displaying Field Level Differences)

5.       Click Apply Changes.
The application performs all the changes you made in the Field Level Screen.

Show Field Level Differences

On click of Continue button in the Record Level Differences screen, the application displays Field-Level Differences. The Field Level Differences Screen displays information, if there are any field level differences in the versions being compared. The differences are displayed along with the child level information.

When you map the old and new versions of the context fields, the respective parent and child values are mapped in a sequential order.

For Example: If an old version consists of parent P with three child records C1, C2, C3, and new version consists of parent P1 with three child records C1a, C2b, C3c and then when you map these two versions at context level, the context records are mapped as mentioned in the following table:

The resulting child records are displayed in the sequential order in the same rows adjacent to each other. When required, perform the appropriate actions and apply the changes.

All the context fields are displayed in a sequential order according to the Rank assigned in the Record Level Differences screen

The Field level differences like E2B, non E2B, data group levels (like Product and Reactions) etc are displayed in the screen.

Field Level Differences

When you click on  product information link, the  Product Informtaion Field Differences page appears with details.

You can perform actions at the following levels:

• Context Level

• Individual Fields

• E2B level/Non E2B Level

Performing Actions on Individual Fields

1.       Select an Action from the drop down

2.       Select Copy all changes from old version at  Non E2B level

3.       Click Apply Changes.

4.       The old value field data like Text, Date, Number etc. is copied appropriately.

5.       Message appears save AER

6.       Click Ok.

Performing Actions at E2B/Non E2B Level

1.       Select an Action from the drop down

2.       Select Copy all changes from old version at Non E2B level

3.       Click Apply Changes.
Individual Field level Action options are Locked for the fields when 'Copy all changes from old version' is selected.

4.       Message appears save AER

5.       Click OK.

All field level changes for E2B and Non E2B fields excluding child level information is saved to the latest version of the case.

Click Back  to go back to the Record Level Differences page. Back button appears only when there are record level changes. Backward navigation does not retain the old modification done in the Field Level Differences Page.  Field level changes are lost once you go back to the Record Level Differences Page.  

Performing Actions at Context Level

1.       Select an action from the drop down

2.       Select Copy all changes from old version'(incl Child)

§  The action at the E2B-Non E2B Level is disabled.

§  The column used for displaying field level actions is colored and you cannot select any action for the field

§  All the changes at the AER_Product record level is copied from the previous version to the latest version.

3.       Select Reconcile Complete to complete the reconciliation status

4.       Click Apply Changes to complete the changes to the AER otherwise AER gets partially updated.

A message appears asking you to confirm on saving the AER with the changes. If you do not select Apply Changes then the AER is Partially completed.

5.       Click Yes.

6.       Select the latest version of the AER to view the copied data.

The status is updated as either Complete or Partially Completed after reconciliation. The reconciliation status field in the database stores

1: Partially Completed

2: Complete

It would still be possible to perform reconciliation multiple times irrespective of the data available in these fields.

The application displays the following message "Field level changes will be lost. Do you want to proceed”

NOTE: If the Person Information is based on "Person Type is of Patient”/ "Vaccine Administrator”/ "Person form completed by”/"Responsible Vaccine Physician” person types, then person type is considered as context data for printing the report, and the lower and higher version data is automatically mapped based on the Person type. Also, you are not allowed to map or unmap such records.

Color Combination

E2B Import module enables the users to see the differences and also apply the changes from the old version to the latest version. In order to show such modifications clearly and effectively, color combination or effects (like strikethrough or bold) are maintained. For example - the data that is marked for deletion in the new version is shown in strikethrough font.

The comparison screens (Record Level) is rendered in such a way that, the user can easily interpret the interrelationship between the Old and new version of AER. The module uses Color coding mechanisms to represent the various types of differences that can be observed between the data in the old and the new versions, both at the Record level and field level.

For each type of action, the foreground color of the field values is different. The various color combinations and its associated functional meaning corresponding to Record and Field differences, that need are represented in the module are described below.

When you reorder the Context field, only the color of the Rank is changed at the record level.

The Color combinations found in the record level differences screen are described below:

The Color combinations found in the Field level differences screen are described below:

Note: Refer E2BColorCoding file available under the 'Properties’ folder of ARIS installation, for default color combination.

Default Action Settings

To maintain the default actions for each table while reconciling case information using E2B Imports module a new property file 'DefaultE2BActions’ is provided.

The format of the property file is as follows:

TableId=RecordLevel; ContextLevel; E2BLevel; Non-E2BLevel

The action should be specified based on the constants below

Record Level: Default Context Level Actions

0 - No Action

1 - Copy old record

2 - Copy old record incl. child

3 - Delete New Record

4 - Mark As Deleted

Field Level: Default E2B & Non E2B Level Actions

0 - No Action

6 - Copy all changes from old version

7 - Copy all changes from old version incl.child

If the default action is not defined for a table, then it is treated as "No Action”. The System does not validate any action while displaying the default actions on the screen.

Appendix-A

Modules used in record level difference of compare and reconcile module are as follows:

1.       AER_PERSON (Person Information)

·          Reporter and MR details

2.       AER_SOURCE (Source Information)

3.       AER_PRODUCT (Product)

·         Suspect Product

·         Concomitant product

·         Vaccine given on same day

·         Vaccine given prior 4 weeks

·         Premedication

·         Drug Used to Treat AE

·         Interacting

·         Past

4.       AER_REACT (Reaction)

·         Current

·         Past

5.       AER_PATIENT_DETAIL (Patient Details)

6.       AER_LITERATURE (Literature information)

7.       AER_LAB (Laboratory information)

8.       AER_CHILD (Child data)

9.       AER_PATIENT_RECORD (Patient Record)

10.   AER_RISK_FACTOR (Risk Factors)

11.   AER_LINK (AER Link information)

12.   AER_PROGRESS_OF_AER (AER Progress Information)

13.   AER_AT_UNITS (AER at Unit Information)

14.   AER_STUDY_PRODUCT_DETAILS

15.   AER_SIMPLE_QC

16.   AER_COMPL_INVESTIGATION

17.   E2B Report Duplicate

Appendix-B

The tables used for  field level differences are as follows:

The tables used for Parent - Child relations in compare and reconcile module for Field Level differences are as follows:

The single records tables which display only in field level differences are as follows:

·         AER

·         AER_AE_CHAR

·         AER_STUDY

·         AER_DEVICE_ENG_EVAL

·         AER_DEVICE_CAPA

·         AER_PRODUCT_COMPLAINTS

·         AER_PATIENT

Comparing and Reconciliation of Follow-up cases

Following is a scenario depicting the process of Compare and Reconcile for an E2B case.

You can compare and reconcile the case and the follow-up information received and adopt the information from follow-up into the current version.

1.       Login to ARISg.
The following message appears on receiving the follow-up case from IRT.

2.       Consider the following case available in the Notification window.
You can take action on the notifications in a sequential manner of the recepit of notifications.

Following table describes the status of buttons in various scenarios.

3.       Click Compare and Reconcile.
The application displays the record level differences as shown below:

When the application has similar products in the follow-up and in the case, but differ in their content in the context fields, then the application allows you to explicitly map the displayed versions.  Mapping helps you compare information and there by enables you to copy the information in the follow-up to the latest version of the case.  When you are comparing two versions of a case, the application displays all the records in the Record Level Differences screen.

The application supports the Blind or Unblind product by allowing you to copy from follow-up to the latest version of a case.

In the Record Level Differences screen, the Normal/Blinded/Unblinded records are displayed as separate links under Modules in the left pane, as follows:  

·         Suspect

·         Suspect Blinded

·         Suspect Unblinded

·         Vaccine given on same day Blinded

·         Vaccine given on same day Unblinded

 Before performing the following steps make sure you have privileges and update access to AER to reconcile AERs. Based on the settings in the Field Maintenance screen of the Admin application, the application displays the fields under E2B fields or Non E2B fields in the Compare and Reconcile screen.

All the Unblinded records mapped with the Suspect blinded record are displayed when you click the Suspect Unblinded link.  Similarly, all the Unblinded records corresponding to Vaccine given on same day blinded record are displayed when you click the Vaccine given on same day Unblinded link. Before performing any actions on any Unblinded record, ensure to map the corresponding Blinded record.

The Data Privacy is supported and the users having access privilege can view the decrypted data displayed in the Data privacy fields.

5.       Select Keep old record in the action drop-down to retain the information in the latest version.
Following options are available in the Action drop-down.

·         Keep Old Record

·         Add/Copy new Record

·         Add/Copy new Record with child data

·         Delete old Record

·         Mark as deleted

·         Logically deleted

Changing the Rank of Context Fields

For Example:

To change the rank of the sulphur field:

1.       Select Sulphur in the case.

2.       Click the Down arrow key    twice.

The application changes the current rank of Sulphur from 2 to 3.

Similarly you can rank the other products available in the latest version of the case. You can only rank the products that belong to the following type of Products:

·         Suspect Product

·         Concomitant product

·         Vaccine given on same day

·         Vaccine given prior 4 weeks

·         Premeditations

·         Current Reaction

·         Past Reaction

The context field in the application, display code and decode value in the brackets. If the data is too long, then double-click on the corresponding value to view the complete data.

Blind and Unblind products of the previous version must be mapped and copied to the Blind and Unblind products respectively.

Note: You can de-associate and again map the records that are already mapped by the application in earlier versions of a case.
The application displays all the records of the context fields in the Record Level Differences screen even though the same value is available in the context fields of follow-up and in the latest version of the case.
For Simple QC, mapping/unmapping of Simple QC records is not supported. By default the "Item” field is selected as "Context” field. Also, it is recommended not to change the Item field as context field. If you click "Map/Unmap” button, the application displays the message” cannot map/unmap Simple QC Records”.

Unmapping of Context Fields
  

You can UnMap the context fields only if the fields are explicitly mapped.

1. Select  paracetamol.

2. Click UnMap. The application UnMaps the fields. You can Un-Map the records that are already mapped by the application.

3. Click Continue. A message appears confirming if you are done with the Record level differences.

4. Click Yes.

      The application displays Field-Level Differences. The Field Level Differences Screen displays information, if there are any field level differences in the versions being compared. The differences are displayed along with the child level information.

When you map the context fields of follow-up and the latest version of the case, the respective parent and child values are mapped in a sequential order.

For Example: If the latest version of case consists of parent P with three child records C1, C2, C3, and follow-up consists of parent P1 with three child records C1a, C2b, C3c and then when you map these two versions at context level, the context records are mapped as mentioned in the following table:

The resulting child records are displayed in the sequential order in the same rows adjacent to each other.

All the context fields are displayed in a sequential order according to the Rank assigned in the Record Level Differences screen

The Field level differences like E2B, non E2B, data group levels (like Product and Reactions) etc are displayed on the screen.

Action on Field Level Differences

The screen displays field level differences at E2B and Non E2B Level. You can perform actions at the following levels:

• Individual Fields

• E2B level/Non E2B Level.

• Context Level

1.       Select an Action from the following options available in the drop-down for the required fields.

·         Keep Old value

·         Add/Copy new value

·         Delete old value

The old value like Text, Date, and Number etc. are copied appropriately.

Save AER message appears.

2.          Click Ok.

Performing Actions at E2B/Non E2B Level

1.       Select an Action from the drop-down. Following options are available;

·         Keep Old value

·         Add/Copy new value

·         Delete old value

2.       Select Add/Copy new value at E2B or/and Non E2B level.
Save AER message appears.

3.       Click Ok.

All field level changes for E2B and Non E2B fields excluding child level information is saved to the latest version of the case.

Performing Actions at Context Level

1.       Click General Information link.

2.       Following options are available in the drop-down. Select Add/Copy all changes from follow up option at the E2B Fields level.

·         Keep Old Value

·         Add/Copy all changes from follow-up

·         Add/Copy all changes from follow-up with child data

All the changes at the General Information record level are copied from the follow-up version to the latest version

The column displaying new value turns green.

3.       Similarly perform the same action for the other modules.

4.    You may select Reconcile, if you wish to revisit the changes.
The status displays as Follow up information is in progress in the Status window.

5.    To complete the reconciliation, select the same record which has status Follow up informtaion is  in progress and click Compare and Reconcile.
A message appears asking you to confirm on saving the AER with the changes. Click Apply Changes to complete the changes to the AER otherwise AER gets partially updated.

6.    Click Yes.
The Status in the notification window gets updated as indicated in the following image.

Click Back to go back to the Record Level Differences page. Back button appears only when there are record level changes. Backward navigation does not retain the old modification done in the Field Level Differences Page.  Field level changes are lost once you go back to the Record Level Differences Page.  

Note: If the Person Information is based on "Person Type is of Patient”/ "Vaccine Administrator”/ "Person form completed by”/"Responsible Vaccine Physician” person types, then person type is considered as context data for printing the report, and the lower and higher version data is automatically mapped based on the Person type. Also, you are not allowed to map or unmap such records.

Color Combination

E2B Import module enables the users to see the differences and also apply the changes from the old version to the latest version. In order to show such modifications clearly and effectively, color combination or effects (like strikethrough or bold) are maintained. For example - the data that is marked for deletion in the new version is shown in strikethrough font.

The comparison screens (Record Level) is rendered in such a way that, the user can easily interpret the interrelationship between the Old and new version of AER. The module uses Color coding mechanisms to represent the various types of differences that can be observed between the data in the old and the new versions, both at the Record level and field level.

For each type of action, the foreground color of the field values is different. The various color combinations and its associated functional meaning corresponding to Record and Field differences, that need are represented in the module are described below.

When you reorder the Context field, only the color of the Rank is changed at the record level.

The Color combinations found in the record level differences screen are described below:

The Color combinations found in the Field level differences screen are described below:

Note : Refer E2BColorCoding file available under the 'Properties’ folder of ARIS installation, for default color combination.

Default Action Settings

Record Level: Default Context Level Actions

0 -  Keep old record

1 - Add/Copy new record

2 - Add/Copy new record with child data

3 - Delete old Record

4 - Mark As deleted

5 – Logically deleted

Field Level: Default E2B & Non E2B Level Actions

0 – Keep old Value

6 – Add/Copy all changes from Follow-up

7 - Add/copy all changes from follow up with child data

If the default action is not defined for a table, then it is treated as "No Action”. The System does not validate any action while displaying the default actions on the screen.

Appendix-A

Modules used in record level difference of compare and reconcile module are as follows:

2.       AER_PERSON (Person Information)

·          Reporter and MR details

4.       AER_SOURCE (Source Information)

5.       AER_PRODUCT (Product)

·         Suspect Product

·         Concomitant product

·         Vaccine given on same day

·         Vaccine given prior 4 weeks

·         Premedication

·         Drug Used to Treat AE

·         Interacting

·         Past

5.       AER_REACT (Reaction)

·         Current

·         Past

18.   AER_PATIENT_DETAIL (Patient Details)

19.   AER_LITERATURE (Literature information)

20.   AER_LAB (Laboratory information)

21.   AER_CHILD (Child data)

22.   AER_PATIENT_RECORD (Patient Record)

23.   AER_RISK_FACTOR (Risk Factors)

24.   AER_LINK (AER Link information)

25.   AER_PROGRESS_OF_AER (AER Progress Information)

26.   AER_AT_UNITS (AER at Unit Information)

27.   AER_STUDY_PRODUCT_DETAILS

28.   AER_SIMPLE_QC

29.   AER_COMPL_INVESTIGATION

30.   E2B Report Duplicate

Appendix-B

The tables used for field level differences are as follows:

The tables used for Parent - Child relations in compare and reconcile module for Field Level differences are as follows:

The single records tables which display only in field level differences are as follows:

·         AER

·         AER_AE_CHAR

·         AER_STUDY

·         AER_DEVICE_ENG_EVAL

·         AER_DEVICE_CAPA

·         AER_PRODUCT_COMPLAINTS

·         AER_PATIENT

Reconciliation Report

The Report displays the details from a case which has received a follow-up and Reconciliation is complete. The reports displays old value, new value, action taken and the LRN number which is being compared. 

Partially completed reconciliations will not be considered in the reconcilation report.

You can generate the report for a case from ARISgàReportsàAdministrationàReconciliation Status Report when the case is open.

Tracking the Follow-up

Click FormsàFull Data EntryàGeneralàMore LinkàFollowup Documents, the following notification screen appears.

You can view the follow-ups received and the actions taken for each of them in a case.  This is accessible when the case is opened from QBE or Workflow.