Bulk Unblind Isolated Blinded Product Information

For Vaults configured to isolate blinded clinical trial information, you can unblind all Cases under a completed Study at once.

About Bulk Unblind Isolated Blinded Product Information

When a blinded clinical trial for a study without study arms ends, you can unblind all Cases at once as part of the end-of-study reconciliation. When you unblind Cases in bulk, Vault removes blind protection for previously unblinded Cases and populates Study Product information for blinded closed clinical trial Cases. Depending on your Admin’s configuration of suspect products, Vault unblinds Study Products with a Drug Role of Suspect, Interacting, and Drug Not Administered.

Vault preserves all Case processing information by generating separate blinded and unblinded records for all global and localized records. Vault updates the applicable Study record and creates follow-up Cases for closed Cases that were not unblinded before the bulk unblind process. Vault records updates in the applicable audit log. Vault does not modify in-progress Cases as part of unblinding.

This feature is available for Vaults configured to isolate blinded clinical trial information. For Vaults without this configuration, see Bulk Unblind a Study for information on how to unblind all study Cases at once.

Procedure Overview

To unblind all Cases under a completed Study at once:

1. Prepare CSV files for:
   • Study participants
   • Treatment group and blinded product placeholders
2. Complete bulk unblinding
3. Review the summary report

Prerequisites

To use this feature:

• Your Admin must have enabled
  • Clinical Trials: Isolate Blinded Product Information
  • Bulk Unblind
  • Bulk Unblind Studies with Isolate Blinded Product Information
• You must have Business Admin permissions and access to the Study being reconciled.
• The Study must not have Study Arms.

Study Updates

After bulk unblinding all blinded closed clinical trial Cases, Vault updates the source Study:

• Sets the Blinded field to No.
• Sets the lifecycle state to End of Study Reconciliation.
• Adds a bulk unblind summary report to the Attachment section.

Follow-Up Case Creation

After running bulk unblinding, Vault creates a follow-up version of all closed Cases that were not previously unblinded. For each blinded record on the Case, Vault copies the values and creates a separate unblinded record, setting the Blinding Type to Unblinded. Each unblinded record references its associated blinded record. For more information about these dual records, see Isolate Blinded Clinical Trial Information.

Created follow-up Cases are in the End of Study Unblinding state. Vault updates information on these Cases as follows:

• Vault appends text entered in the Narrative Text field on the Bulk Unblinding page to the Narrative document.
• Vault maps text entered in the Unblinding Reason field on the Bulk Unblinding page to the Unblinded Reason field on the Case.
• When the Randomization Number field on the Case is blank, Vault maps the Randomization Number from the CSV file. If needed, Vault truncates the value to 59 characters and appends ….
• Vault updates the New Info Date and Unblinded Date fields to the date of bulk unblinding, based on the initiating user’s timezone.
• Vault sets the Unblinded By field on the Case to Sponsor.
• If the Study Type field is blank, Vault maps the Study Type value from the associated Study.
• Vault evaluates the latest information to update the Case Expectedness, Listedness (Core), and Relatedness fields.

Vault moves previous Case versions to the Superseded state and does not update their data.

Product Information on Unblinded Records

Vault populates unblinded information on blinded Case Product records as follows:

• For Case Products with Study Product Placeholders for clinical trial Study Products with any Study Product Role except Standard of Care, Vault maps the Study Product data:
  • Vault maps the Name of the Study Product to the Product (Coded) field.
  • If the Product (Reported) field is blank or populated with the blinded name, Vault also maps the Name of the Study Product to this field.
• If you choose to add dosage information during bulk unblinding, Vault maps Dosage information from the unblinded Study Product record to the Dosages section of the Case Product.
• If you choose to add indication information during bulk unblinding, Vault maps Indication information from the Study to the Indications section of the Case Product.
  • For Indication only, Vault maps this information to the blinded record as well.

Vault moves blinded Case Product records to the Unblinded state and sets the Blinded field to No.

Case Assessments on Unblinded Records

Vault populates unblinded information on blinded Case Assessment and related records as follows:

• Vault generates Case Assessment Expectedness records for each unblinded Study Product. Vault does not generate Case Assessment Expectedness records for blinded Study Products unless your Admin has configured Datasheet Expectedness for Blinded Study Products.
• Vault generates Case Assessment Result records for each source type, copying values from the blinded record.
• If the Blinding Type field is blank on a Study Product record, Vault generates both blinded and unblinded records.

Localized Cases

If the initial Case has a related domestic Localized Case, Vault creates a follow-up domestic Localized Case that includes all of the new records from the generated global follow-up Case. For unblinded products with PMDA registrations, Vault also generates Case Product Registration, Localized Case Assessment, and Localized Case Assessment Result records. If dosage and indication details were mapped to the global Case, Vault also populates them on the domestic Localized Case.

If the initial Case has related foreign Localized Cases, Vault creates follow-up foreign Localized Cases. However, Vault maps information from the related global follow-up Case upon Transmission generation.

Prepare the CSV Files

Before you begin unblinding, you must upload two (2) CSV files to the Bulk Unblinding page:

• A list of each patient in the study and the treatment group they were in.
• A list of the treatment groups and blinded names for the Study Products.

When preparing the files, consider that:

• The file type must be CSV.
• A file can contain up to 20,000 rows.
• Column headers must have the required names and order.
• Commas (,) in cell values are not supported. This is a known limitation that will be addressed in a future release.

Prepare a CSV File of Study Participants

Each combination of either investigational_mrn and treatment_group or patient_initials and treatment_group must be unique. Use the following column header names and order:

CSV Sample

We recommend reviewing this sample CSV file:

patient_initials,investigational_mrn,study,treatment_group,randomization_number 
AR,pt001,STU-004,Investigational,jfgoubas7823nf982
MM,pt002,STU-004,Investigational,fdggf3212fsdf
SK,pt003,STU-004,Placebo,f32c6665ggdg
FL,pt004,STU-004,Active Comparator,324dsgasd235
EW,pt005,STU-004,Active Comparator,fhhybg57674
SKI,pt006,STU-004,Placebo,mnut564
AL,pt007,STU-004,Investigational,khuyjh754d43
RP,pt008,STU-004,Investigational,75hgf65jhgg
SS,pt009,STU-004,Placebo,hrfg5453

Prepare a Treatment Group and Blinded Product Placeholders CSV File

Each row must be unique. Use the following column header names and order:

CSV Sample

We recommend reviewing this sample CSV file:

treatment_group,study_product,study_product_placeholder 
Investigational,cholecap,Investigational vs. Placebo
Placebo,wonderdrug,Investigational vs. Comparator

Bulk Unblind Cases

Initiate bulk unblinding from a Study record. You cannot bulk unblind Cases across different Studies. For information on unblinding an individual Case for SUSAR reporting, see Manage Case Blinding.

1. Navigate to the applicable Study record.
2. From the All Actions menu, select Launch Bulk Actions.
3. In the Upload List of Study Participants section of the Bulk Unblinding page, select Upload to upload the CSV file of study participants.
4. In the Upload List of Treatment Group and Blinded Product Placeholders section, select Upload to upload the CSV file of the treatment group and blinded product placeholders.
5. (Optional) In the Unblinding Options section, apply updates to the follow-up Case created after unblinding:
   1. In the Narrative Text field, enter up to 2,000 characters to append to the Narrative document.
   2. In the Unblinding Reason field, enter up to 250 characters to populate the Unblinded Reason field on the Case.
   3. In the Dosage Options field, select whether to add Dosage information from the unblinded Study Product to the Dosages section of the Case Product.
   4. In the Indication Options field, select whether to add Indication information from the Study to the Indications section of the Case Product.
6. Select Preview Bulk Unblind. Vault populates the right-hand panel with:
   • The number of Cases that will be unblinded
   • A Summary of Changes
   • Source File Information
7. To apply the details from the bulk unblind preview, select Run Bulk Unblind.

Result

When bulk unblinding completes, Vault generates a summary report of all changes. You can navigate to other pages during report generation. Vault displays a notification when all applicable Cases are unblinded.

Summary of Changes

Cases are categorized by color based on how Vault updates them after bulk unblinding:

Summary Report

Vault generates a summary report of changes from bulk unblinding. When the report is ready, the Vault notification links to the report, which is also attached to the associated Study. The summary report is an XLSX file with the following tabs: