Blinding/Unblinding in ARISg

The Blinding/Unblinding concept in ARISg is applicable for all case classifications.  This concept is enabled at both the Admin and User level, based on the appropriate "Code Broken” settings.

Blinding/Unblinding settings in ARISg

Admin Settings

At the Administrator login, the scenarios in which a case is classified as a blinded or unblinded study are as follows.

 

Blinded study

A case is considered blinded, when it has "Code Broken” set to No (Code not broken) in the Protocol library.

For related information on Code broken status, Refer the guide Library Maintenance

Based on the privilege, users can enter both the blinded and unblinded information.

 

Unblinded study

A case is considered as unblinded, when it has the "Code Broken” set to Yes (Code broken) in the Protocol library.

Based on the privilege and exceptions, users can access the unblinded information.  Only privileged users can view the unblinded information.

 

For related information on unblinded study, refer the guide Library Maintenance.

User Settings

At the case level, users are allowed or denied access to enter the blinded/unblinded information based on the "Case code broken” settings as described below.

 

Case code Broken set to No:  User is denied access to enter the blinded/unblinded information from the below screens:

• All Products

• Standard Product

• Easy entry product

• Vaccine

• Medical devices

Case code Broken is Yes/NO/NA/Not Selected: User can enter the blinded/unblinded information from the above listed screens when the code broken is set as follows in the admin and user modules:

• CODE BROKEN = No (Code not broken) in Admin module and

• CASE CODE BROKEN = Yes/No/NA/Not Selected at the Case level

Blinding/Unblinding Operations in ARISg

Make sure to do the Admin and User settings. Follow the steps to view a Blind and Unblind record.

1. Register a case from AER Registration page.

2. Enter the data from the Full data entry page.

3. Click Product tab, enter the product information from the page. This is your Blind product record.

4. To view the Unblind product record, select Blinded? Option and click the Unblind button.

5. The Unblind product page appears. Refer to the Figure: Product page with "Copied" checkbox.

Based on the privilege assigned to you, the application allows you to perform the below listed operations in blinding/unblinding.

• Deleting records

• Duplicating records

• Copying records
   

Select the parameter Do not show blind records when study is unblinded available in Admin>>Parameters>>Installation Parameters>>General>>General to restrict the application from displaying the blinded records for an unblinded study case in the data entry screens.

Entering Blinding and Unblinding Product Information

You can enter one or more unblinded products to each blinded product.

 

Example 1:  Entering unblinded product information data to a blinded product

1. On the CASE menu, click New.
   The AER Registration page appears.

• Enter the AER no. in the AER Registration page.

• Select a Product type as Drug and select a Classification as Study and click OK.

2. On the Full Data Entry page, enter the basic information such as the Initial unit, Latest received date and Country.

3. Click the Study tab;  enter the Project No and Protocol No for the Study in the Definition section.

4. Click on Lookup to select a project and protocol number.

5. In the Protocol Reference Selection screen, select Study Code Broken as Code not broken.

6. Select Case code broken as Yes.

7. Save and Close the AER.

8. Open the AER from the List of Selected AERs window.

9. Click the Product tab on the Full Data Entry, and enter the product information.

10.  To enter the Unblind product record, select Blinded Record? checkbox and click the Unblind button. The Unblinded suspect product page appears.

11.  Enter the name of the unblinded product in the Product description field.

Example 2: Entering multiple unblinded Products  to a blinded product

 

To add more than one unblinded product information, click the    button on the top right corner of the Unblinded suspect products page.

Deleting Unblinded Information

You can delete blinded or unblinded information based on the privilege assigned to you.

• Privileged Users

When a blinded record associated to an unblinded record is deleted, you are asked to confirm your request as shown below.

Select:

• Yes - To delete the blinded and associated Unblinded records automatically.

• No - To convert the associated Unblinded records to Normal records and added at the end of the suspect product queue when you save.

• Cancel - The records are not deleted.

If the blinded record does not have any associated unblinded record, then the blinded record maybe deleted.

 

• Unprivileged Users

If you do not have access to unblinded information, you cannot delete a blinded record which has unblinded records associated to it.

If the blinded record does not have any associated unblinded record, then the blinded record maybe deleted.

 

Note: The above functionality holds good even for Logical deletion of Blinded and Unblinded records.

Duplicating Blinding/Unblinding Records

When you duplicate a blinded record, only the blinded record is duplicated.  The associated unblinded records are not duplicated.

 

For Example: Consider a blinded product A associated to a set of unblinded records (a1, a2, a3). When you duplicate a blinded record A, only then this blinded record A is duplicated. The associated unblinded records are not duplicated.

Copying Unblinding Records

ARISg helps you to distinguish between the unblinded records created manually and the records that are created using the "Copy” button functionality.

 

You can see the Copied checkbox selected when:

 

• A record is copied using the "Copy button”.

You can see the Copied checkbox not selected when:

• A record is created manually.

Note: The Copied checkbox is not selected by default and is disabled.

 

The Copied checkbox does not appear when:

• The Code broken status is set to Yes in the admin module

• The parent blinded record is deleted and the unblinded records change to normal records.

• Listed below are the screens in which the Copied checkbox is displayed:

Unblinded Suspect Products screens:

• Therapy Tab

• Approval No./Lot No. Tab

• Indication Tab

• Ingredients Tab

• J.12-Studies Tab

In the Unblinded suspect product page, when you attempt to copy the blinded product information using the Copy button, the Blind Information page is displayed. In this page, specify the child data of the product along with which you want to copy the blinded product information for unblinding.

The Blinded Information page appears only when the parameter Copy blinded product information with confirmation check box is selected in the Admin > Parameters > Installation Parameters > Automatic Coding/Labeling tab under the Mapping section.

NOTE: If the Copy blinded product information with confirmation check box in Admin is not selected, the application does not display the Blind Information page and continues to copy all the blinded product information along with the child data for unblinding.

In the Blind Information page, the following three child data check boxes are available:

• Therapy Information

• Labeling Information

• Causality Information

You can select the required check box and click OK to copy the selected child data along with the blinded product information for unblinding.

Unblinded Vaccine screens:

• Vaccine Information

• Dosage Information Tab

• Approval/Lot. No Tab

• Indication Tab

• Unblinded Medical Device screens:

• Approval/Lot. No Tab

• Manufacturer Tab

• Textual Info. Tab

• Medical Codes Tab

• Device Dealers Tab

• Other Reported NCA Tab

 

Note: The AER data report indicates if the unblinded record is a copied record. Illustrated below is the "Copied” checkbox in the Product therapy tab.

Entering Unblinded Causality Information

To enter the Unblinded Causality information, perform the following steps:

1. On the Product tab, select Blinded Record? Option.

2. Click the Unblind button.

3. Click Causality tab. The Unblinded Causality screen appears.

4. Provide necessary details in the fields from the Unblinded Causality screen.

Entering Unblinded Labeling Information

To enter the Unblinded Labeling information, perform the following steps:

1. Select Blinded Record? option.

2. Click the Unblind button.

3. Click Labeling tab. The Unblinded Labeling screen appears.

4. If you are entering manually, then you need to provide the labeling information from the screen.

Note:  If you are viewing the product record which is already created, then the labeling information appears automatically as entered in the admin.