Execute an unblinding profile

This section describes the functional behavior of the Advanced Unblinding module.

Go to Argus > Utilities > Argus Unblinding > Unblinding Advanced.
Select a profile, click View/Modify, and then click Execute.
The application validates the following, before beginning the unblinding execution process.
- User privileges - You must have the following privileges to execute an unblinding profile:
  - Allow unblinding of cases
  - Allow locking of cases
  - Allow closing of cases
  If you do not have any of these privileges, a relevant message appears.
- Each product mapping must be unique. Each treatment must be mapped to a different study in the product mapping.
- A study drug mapping for every treatment code is added.
- Reporting workflow and Reports Group are provided, if Run Reporting Rules is checked.
- If Dosage Options is selected as Add to Existing Dosage or Replace all by following Dosage, then dosage regimen values are provided.
When successfully validated, the execution process runs in the background through AG service with the following details:
- Task Name: End Of Study Unblinding
- Default User ID: oagsvc_end_of_study_unblinding_1
- Multiple Instances Allowed: Yes

You can execute multiple different unblinding profiles at the same time by one or multiple users.

However, when the execution process starts for a profile, for all users, Configuration screen becomes un-editable and in the read-only mode until the unblinding process completes for that profile. Besides, you cannot cancel the execution process.

Criteria for a case to qualify for unblinding

A qualifying case must meet one of the following criteria:

Case belongs to the specified clinical study ID (including archived cases).
Case has not had the blind broken previously. That is, the Blinding Status field is not equal to Broken by Sponsor or Broken by Investigator.
Case has not previously been successfully processed by the End of Study Unblinding program.
Case satisfies the advanced condition, if specified.
Case is not deleted.

Note:

The case status (whether it is open, closed, locked etc.) is irrelevant at the start of the process. Unlocked and open cases fail during the unblinding process.

Process the qualifying case

For each qualifying case the following processing is performed:

If the case is not locked or case is not closed (open by a user), then the case ID is added to the exception tables, with the failure reason Case is unlocked (globally and/or locally) or open.
If the case is currently closed, add the re-open information to record that the case has been re-opened by EOSU.
If the case is locked (both Global and Local), then add the unlock information to record that the case has been unlocked by EOSU.

Inspect the Patient Randomization tables

Inspect the Patient Randomization tables to map the patient for the current case with a specific study product based on the following algorithm:

Select the Country of Incidence, Study ID and Patient Randomization Number (or) Patient ID for the current case.
If any of the data is NULL for the case being processed, then write an exception Case is missing Country or Study or Center or PRD#. Blind cannot be broken without these fields. and move to the next case.
Attempt to find a matching record in the randomization data using the Country, Study ID, Centre Number and Randomization number (or) Patient ID obtained from the current case.
During the above matching against the randomization data, all records with either of the columns (Study, Country, Center, Randomization Number, and Treatment Code) as invalid are not considered for a match.
If duplicate entries in the randomization data are obtained for this combination, then log the message Duplicate entries in Randomization Data (Study+Rand#/Patient ID) are matching the Case Data. in the exception report and move to the next case.
If a match is found, then read the study drug treatment code for that randomization record. This is based on the Treatment Code to Study Product mapping table. That is, an attempt is made to match the Study Drug of the current case with the relevant randomization record via the Treatment to Study Product mapping table.
If no record can be found, then write the case ID to the exception list, along with the failure reason, and move onto the next case.
If the study drug mapped to the treatment code does not belong to the study name/study arm the patient belongs to in Argus Safety case, then an error message appears in the exception log as The Patient Exposure drug could not be located in LM_STUDIES.

Dosage regimen

If the derived Study Drug is configured with dosage regime, then dosage regimen in case is marked as updated/added/no updates made based on the profile configuration settings. The case’s Un-Blinding Status field is set to Broken After Study, Un-blinding date is set to System (Database) date and time, and set the Product Administered Drug for the Study Drug.

Unblinding of other drugs

Unblinding of Investigational, Comparator, Additional or Placebo Drugs also follow the same logic. Unblinding must be performed using the company product or WHO Drug products.

If any new expedited reports are scheduled, then set the Case Workflow State to the Reporting Workflow State and assign the report to the configured reporting group.

When Unblinding is complete

Event Assessment is recalculated after the case is unblinded.
If the case was locked at the start of the process, then re-lock it.
If the case was closed at the start of the process, and the case does not have regulatory report scheduling due, then re-close it.
If any expedited reports are scheduled, then lock the case, irrespective of the state of the case prior to processing.
Create a significant follow-up entry for the current case – giving the current date as the date of follow up and the central receipt date.
Save the changes to the case (i.e., commit the changes to the database; set the Last Saved Date to the current date and time; set the Last Update user to the value of the current Argus Safety username).