Executing Batch Unblinding Process

Unblinding is a process of breaking the code of the patient in an investigative group. It is a procedure in which the patient and/or the investigator is made aware of the treatment and the products taken. This process is performed generally at the end of the study or when a serious adverse event occurs.

ARISg application enables you to execute Batch Unblinding process, in which, a set of cases satisfying a criteria are unblinded. During this process, Patient number from the randomization file is compared with the Patient number available in the study case. The blinded products in the case get replaced with the unblinded products maintained in the randomization file to form a new version of the case.

Performing Batch Unblinding Using Randomization File

Close all the cases before performing batch unblinding.
The application does not include logically deleted cases for batch unblinding.

To execute batch unblinding do the following:

Create Randomization File
Use Randomization File for Batch Unblinding

Following are the steps of a scenario, which depicts the process of entering data in Admin and ARISg application.

Admin Settings

1. Download the Randomization File template from the Admin>Library>Protocol Search screen.

2. Enter the data as follows.
Multiple Unblinded products can be added row wise with the same Patient ID.

Creating Protocol.
Protocol Library maintains study information on Blinded cases.

Enter Study details.
Enter Study Design details.
Set the code broken? field to code not broken.
Choose the created randomization file.

4. Uploading the Randomization file

In the Library>Protocol Maintenance>Upload randomization file section, click Choose File button to upload.
Select the file. Make sure that the file is in XLS or XLSX format.
On saving the protocol, the uploaded randomization file appears in Library>Protocol Maintenance>Batch Unblinding section.
You can download the randomization file by using icon.
Enter Other Details
Save the new protocol record.

5. Add the following additional details to the newly created Protocol record.

Click the Add button in the Protocol Maintenance page to add a new treatment arm for the Study Protocol.
Enter the right treatment that was given to the subject.
Click the Add button in the Protocol Maintenance page to add a new registration number for the study protocol.
Click the Add button in the Protocol Maintenance page to add a new product for the study protocol.
On the Protocol Maintenance>Vendors page, click Add, to add a new vendor for the study protocol.
Select the check boxes to copy labeling, therapy and causality details from blinded product in the case to the unblinded products created in the new version.
Select the fields to copy the data from the Randomization File to the case. The fields Update case significance and Update event description are updated from the Protocol screen.

6. Save the data.

ARISg Settings

Entering Case Data

Log on to ARISg application to enter the Registration information.
Select Product type and Classification.
Select Forms > Full Data Entry.
Enter the Latest received date in the General tab page.
Click Study tab to select the Protocol number you entered in the Admin application from the Protocol Lookup.
Enter the Patient no in the Study screen
Enter the Product description in the Product tab page.
Select the Blinded Record Check box.
Save and close the case.

2. Running Batch Unblinding

Select Case>Batch>Batch Unblinding.
Enter the Protocol number you entered in the Admin application.
If required, select the options to copy the Therapy, Labeling, and Causality details.
You may include manually unblind cases by selecting the check box Manually Unblinded cases.
Choose the Randomization file.
Before running the batch unblinding, Click Run Impact analysis, the report compares Randomization file data with the case data.
You may use this report to ensure the accuracy of data in the case and in the file. Click Run Batch Unblinding.
Your access to batch unblinding depends on the selection of the Batch unblinding privilege available in Admin>Security>Roles Privileges Maintenance>Privileges>AER Data Entry>Batch Unblinding

Batch Unblinding Reports

Click Batch Unblinding Reports button.
The application prompts that your request is submitted.
The report is sent to the background server.
Use the refresh button to view the latest changes.
The unblinding status appears in the status column.
Select a record and click the Unblinding Report button. Unblinded report displays only successful unblinded case data.

Batch Error Report: The cases which have failed during the Batch unblinding process gets displayed in this report.

Following reasons may cause the failure of Batch Unblinding process.

Missing Patient ID
Mismatch in Patient ID
Locked Case
Logically deleted case

Click View Impact Analysis Report button before running the batch unblinding, this report checks the correctness of Randomization file data with the Case data.

On click of Unblind button the application performs the following operations:

Filters the cases for the latest version. The latest version if unapproved, then the application automatically approves the case
Creates a new version of the case.
Creates Product records for each of the unblinded product information available in the Randomization file. The application appends the existing products to the created products.
Copies therapy, labeling and causality from blinded to unblinded products.
Blinded products gets deleted from the new version of the case.
Sets the Latest received date for the new version to the current date.
Sets Study code broken and Case code broken to "Yes” after batch unblinding process.
Sets Study code broken date to the date entered in the selection criteria. When blank, the application sets the code broken date to systems date.

Note: The application creates a new version of the case irrespective of the installation parameter "Condition for adding version” settings.

The application generates a report displaying the number of cases successfully unblinded. Click Cancel, to exit the batch unblinding.

Field	Description
AER .No	Indicates the AER that created.
Version	The version of the AER that contains the unblinded products, after performing batch unblinding process.
Unblinding products	The Unblinded products copied from the Randomization file
Status	Indicates the Result of the Batch Unblinding process. Unsuccessful - Case is already unblinded Unsuccessful - Atleast one versions of the Case is opened for editing Successful - Case successfully unblinded Unsuccessful, Case does not have Patient number matching with Randomization file The application allows to re-execute the batch unblinding process by knowing the status in the report.

Summary: The report displays the total number of case identified for batch unblinding. Open the version of the AER indicated in the report. You find that the case contains the copied unblinded products from the Randomization file.

Note: The procedure Execute_on_unblind enables you to add logic for additional operations to be performed during batch unblinding. The procedure has default logic of truncating 'B_’ text in the CDC code for double blinded cases. CDC code is used only in the ARISj application. The logic of truncating text can be stopped (by commenting) in the "execute on unblind” procedure, if it is not required.

Searching Records

Enter the text to search records.
The application searches the text columns of the report and displays the matching records.

Exporting to Excel

Click the Export to Excel button, to export records to XLS file.
The file gets saved in the following format.
Open the file to view the details.