Bulk Unblind a Study

You can bulk unblind all Cases under a Study using the bulk unblind operation.

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About Bulk Unblind

Once your blinded clinical trial ends, you can use the bulk unblind operation to unblind all Cases under a Vault Safety Study as part of the end of study reconciliation.

Bulk unblind removes blind protection for previously blinded Cases and snapshots product information for blinded, closed Cases. Cases currently being processed are not modified by bulk unblind.

You can initiate bulk unblind from a Study record. You cannot use bulk unblind for Cases across different Studies. For instructions to unblind an individual Case for SUSAR reporting, see Manage Case Blinding.

Procedure Overview

At a high-level, bulk unblind involves the following steps:

  1. Prepare a CSV file with the study participants
  2. Trigger bulk actions from the Study
  3. Complete the Bulk Unblinding Screen

Audit Logging

When the bulk unblind operation runs, all changes are recorded in the applicable audit log as “System on behalf of {user}.”

Prerequisites

  • You must be a Business Administrator with access to the target Study to perform bulk unblind.
  • The Study must be configured with Study Arms.
  • Ensure your Vault has the necessary configuration to enable this feature.

Prepare the Study Participants CSV File

You must upload a CSV file to complete the Bulk Unblinding screen. The CSV file should list each patient in the study and the treatment group they were in.

See the following considerations when preparing the CSV file:

  • The file can contain up to 20,000 rows.
  • Each row must be unique.
  • A Case's Investigational MRN or Patient ID must match a row to be included in the unblinding operation. If a Case doesn't match a patient, it is still included in the summary report.
  • Each Case can map to exactly one row.
  • Each row can map to any number of Cases, or none.

CSV Sample

See the following example CSV list:

patient_initials,investigational_mrn,study,study_arm,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

CSV Format

The following table describes the columns supported in the CSV file:

Column Character Limit Description
patient_initials 60

Each row must specify at least one patient identifier to match to a Case, which can be patient_initials or investigational_mrn or both.

This value matches to the Vault Safety Case > Patient Initials (patient_id_value__v) field.

investigational_mrn 20

Each row must specify at least one patient identifier to match to a Case, which can be patient_initials or investigational_mrn or both.

If both values are specified and there is a conflict on a matching Case, the investigational_mrn takes precedence over patient_initials.

This value matches to the Vault Safety Case > MRN - Investigation (mrn_investigation_value__v) field.

study -

Identifies the study to match Cases for the bulk unblind process. The value must exactly match either the Name on the Study linked to the Case, or the Study Number on the Case.

This value matches to either of the following Vault Safety fields:

  • A. Case > Study > Name (name__v)
  • Or
  • B. Case > Study Number (study_number__v)
study_arm -

Identifies the treatment group the patient was assigned. The value must exactly match a valid Study Arm name.

This value matches to the Vault Safety Case > Study Arm > Name (name__v) field.

randomization_number 200

(Optional) Identifies the patient's randomization number from the clinical trial randomization system.

The system snapshots this value to the Randomization Number (patient_randomization_number__v) field to the Follow-Up Case version.

Trigger the Bulk Unblind User Action

Initiate bulk unblinding using the Launch Bulk Actions user action from the All Actions (All Actions) menu on the Study.

Once you trigger this action, the Bulk Unblinding screen appears.

Complete the Bulk Unblinding Screen

The following image shows the Bulk Unblinding screen:

Bulk Unblinding Screen
Bulk Unblinding Screen
  • 1Upload List of Study Participants: Upload the CSV file that lists each patient in the study and the treatment group they were on.
  • 2Narrative Text: You can enter up to 2,000 characters, which will be appended to the narrative document on Follow-Up Cases created as a result of the bulk unblind action.
  • 3Unblinding Reason: You can enter up to 250 characters, which will be populated in the Unblinded Reason field on Follow-Up Cases created as a result of the bulk unblind action.
  • 4Dosage Options: To snapshot Dosages to Follow-Up Cases created as a result of the bulk unblind action, select "Add if none present".
  • 5Indication Options: To snapshot Indications to Follow-Up Cases created as a result of the bulk unblind action, select "Add if none present".
  • 6Preview Bulk Unblind: Select this button to process the uploaded CSV file. Once you select this button, the system validates the contents of the CSV file and shows a summary of the Cases found for the bulk unblind operation.
  • 7Summary of Changes: Once the system has processed the CSV file, this section shows a summary of the Cases found. Cases are divided into colors by category. The following table outlines different categories and the bulk unblind impact on each:
    Category Color Description
    Previously Unblinded Cases Green These Cases have been unblinded, which is identified by the following attributes:
    • The Case Blinded (blinded__v) field is set to No.
    • The Case Blind Protection (blind_protection__v) field is set to Yes.

    These Cases can be in any lifecycle state, including a Closed state.

    Once the bulk unblind action runs, the system removes blind protection from these Cases and all related documents.

    Closed Cases Blue These Cases meet the following criteria:
    • The Case Blinded (blinded__v) field is set to Yes or blank.
    • The Case is in the Approved or Closed lifecycle state.

    Once the bulk unblind action runs, the system creates a new Case version with follow-up information added.

    Inflight Cases Purple These Cases meet the following criteria:
    • The Case Blinded (blinded__v) field is set to Yes or blank.
    • The Case is in any active lifecycle state (such as Data Entry, QC, Medical Review).

    The system does not make any changes to these Cases through the bulk unblind action.

    Cases Without a Matching Patient Red

    These Cases are associated with the Study but did not match a patient identifier in the CSV file.

    The system does not make any changes to these Cases through the bulk unblind action.

  • 8Source File Information: Once the system has processed the CSV file, this section displays a summary of the file contents.
  • 9Run Bulk Unblind: Once you have confirmed the settings and summary are correct, select this button to run the bulk unblind action.

Note You can navigate to other pages while the operation runs in the background. Vault sends a notification once the bulk unblind operation is complete.

Summary Report

Vault Safety generates a summary report for each successful bulk unblind operation. Once the operation is complete, the Vault notification includes a link to the summary report. The system attaches the Summary Report to the Study.

The summary report is an XLSX file that includes the following tabs:

Tab Description
Input A summary of the input options specified on the Bulk Unblinding screen, the user who ran the action, and the date and time when the action ran.
Summary A summary of the number of Cases in each category.
Activity Log A detailed log of each Case evaluated by the bulk unblind action and the action taken. The Activity Log includes the following columns:
  • case: The Case name
  • wwuid: The Case Worldwide UID
  • action_taken: The action the system took on the Case. This can be one of the following actions:
    • Blind Protection removed (Previously Unblinded Cases)
    • Follow-up created and unblinded (Closed Cases)
    • No action (Inflight Cases and Cases Without a Matching Patient)
  • arm: The Study Arm name
  • message: Any warning or error messages will appear here if applicable.
  • patient_id: The patient identifier used to match the Case to the CSV file.
  • fields_updated: List of Vault fields modified by the bulk unblind action.
Bulk Unblind Summary Report Activity Log
Bulk Unblind Summary Report Activity Log

Bulk Unblind Study Modifications

Once the bulk unblind operation runs, the system makes the following changes to the source Study:

  • Sets the Study Blinded field to "No"
  • Sets the Study lifecycle state to End of Study Reconciliation
  • Adds the bulk unblind Summary Report as an attachment to the Study

Bulk Unblind Follow-Up Case Updates

When the bulk unblind action runs, the system creates a follow-up version of all closed Cases that have not been unblinded (blue category). The Follow-Up Case is assigned the End of Study Unblinding lifecycle state.

New data is not added to the previous Case version, and the previous version moves to the Superseded lifecycle state.

For Follow-Up Cases created as a result of the bulk unblind action, the system updates certain information on the new Case version. Some changes are conditional, which are identified in the following table:

Case Property Changes
Narrative Document The system appends any text entered in the Narrative Text field on the Bulk Unblinding screen to the narrative document.
Randomization Number Field When the Randomization Number (patient_randomization_number__v) field is empty, the system snapshots the Randomization Number if it is available in the CSV file. The value is truncated at 60 characters to adhere to the field limit.
New Info Date Field The system updates the New Info Date (new_info_idate__v) field to the point in time when the operation was run in the initiating user's timezone.
Unblinded Reason Field The system populates the Unblinded Reason (unblinded_reason__v) field with the text entered in the Unblinding Reason field on the Bulk Unblinding screen.
Unblinded Date Field The system updates the Unblinded Date (unblinded_date__v) field to the point in time when the operation was run in the initiating user's timezone.
Unblinded By Field The system sets the Unblinded By (unblinded_source__v) field to Sponsor (sponsor__v).
Study Type Field If the Study Type (study_product_reason__v) is blank, the system sets the field value to the Study Type specified on the Study.
Blinded Field The system sets the Blinded (blinded__v) field to No.
Case Product Record The system updates the Case Product for the blinded Study Product with the actual Study Arm Product the patient was administered in the treatment group.
Case Product Dosage Record When the Dosage Options field on the Bulk Unblinding screen is set to "Add if none present", the system snapshots the dosage from the associated Study Arm Product. This change only occurs if the Case Product does not contain any Dosage records.
Case Product Indication Record

When the Indication Options field on the Bulk Unblinding screen is set to "Add if none present", the system snapshots the Indication field value from the associated Study Arm Product.

If the Study Arm Product does not have an Indication specified, then the system snapshots each Indication under the Study.

This change only occurs if the Case Product does not contain any Indication records.


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