Isolate Blinded Clinical Trial Information

Learn about Vault Safety’s features that protect and control the blind for Clinical Trial Study Cases.

About Isolating Blinded Clinical Trial Information

The Clinical Trials: Isolate Blinded Product Information feature offers Vault Safety’s most advanced approach to protecting blinded information for Clinical Trial Study Cases. We recommend adopting this feature to ensure optimal processing of your blinded Clinical Trial Study Cases from start to finish. This feature offers the following significant advantages over other methods of managing Case blinding:

• Dual records preserve all of the information from before and after unblinding for all global and localized records
• Support for independent assessments of unblinded Case Products during the Medical Review process
• Blind protection supports overall clinical trial integrity when distributing SUSARs to ethics committees and study sites
• Accurate reporting to both regulatory and non-regulatory health authorities
• A clear user interface to help users easily differentiate blinded from unblinded information
• Expectedness generation for blinded study products.

This feature also includes an option to turn off blind protection on Narrative documents.

Prerequisite

Your Admin must enable Clinical Trials: Isolate Blinded Product Information.

Overview

For blinded Clinical Trial Study Cases, Vault Safety initially creates one (1) set of records with the Blinding Type set as Blinded. Blinded records store information that is not blind-sensitive.

Vault Safety considers the following Study-related object fields blind-sensitive:

Object	Fields
Case Product	Product Coded Product Study Product Name Combination Product Lot Number Model Number MPID Product Registration Serial Number Study Arm Product Substances Trade Name Unique Identifier
Case Product Dosage	All
Case Product Substance	All
Case Product Registration	All
Case Assessment	Name Expected Expected (status) Listedness Listedness (status) Reaction Recurrence
Case Assessment Expectedness	All
Case Assessment Result	Assessment Result Override Causality Established
Localized Case Product	Local MPID Product (Coded)
Localized Case Product Dosage	All
Localized Case Product Substance	All
Localized Case Assessment	All
Localized Case Assessment Result	Result (text)

If you unblind a Case, Vault Safety isolates the unblinded from the blinded information by creating a second set of these records. To create the unblinded records, Vault Safety copies the values from the blinded records. The unblinded records have the Blinding Type set as Unblinded and include a reference to the blinded record in the Blinded Reference field. The previously existing blinded records are unchanged in this process.

Only users with the appropriate permissions can view unblinded records.

To unblind Cases all at once, see Bulk Unblind Isolated Blinded Product Information.

Select the Blinded or Unblinded View

Vault Safety maintains a clear separation between blinded and unblinded data through Action Layout views. Isolating data assists Medical Reviewers in quickly identifying which type of information they are viewing. Users with appropriate permissions for viewing unblinded information can switch between the views of the Case.

To switch between views, go to the Navigation Panel and select either the blinded or unblinded view.

Blinding Type and Blinded Reference

To identify the type of blinding on an object, refer to the Blinding Type field, which Vault Safety sets to one (1) of the following:

• Blinded
• Unblinded
• Open
• blank (For example, non-Study or External Products)

In addition, on records with a Blinding Type of Unblinded, Vault Safety populates the Blinded Reference field with a link to the associated blinded record.

Promoting Inbox Items for Clinical Trial Cases

When promoting Inbox Items for blinded Clinical Trial Study Cases, Vault Safety generates blinded and unblinded records based on the Study Product Drug Role and Blinded field settings. Depending on your Admin’s configuration, for Products with a Drug Role of Suspect, Interacting, or Drug Not Administered, Vault Safety considers the Inbox Item Study Product Blinded field setting as follows:

• If set to Blinded, the promoted Case includes blinded records only and the Blinding Type is set to Blinded.
• If set to Unblinded, the promoted Case includes both blinded and unblinded records as follows:
  • On blinded records, the Blinding Type is Blinded.
  • On unblinded records, the Blinding Type is Unblinded and the Blinding Reference field references the blinded record.
  • The Case Product and Product Registration is set using the Inbox Item Study Product and Product Registration.
• If set to Open-Label, the Blinding Type is Open.

If your primary Case Product is unblinded, the primary Case Product is set on the blinded record, not the unblinded record.

Blinded Products on the Potential Matches Page

During Case promotion, when running Duplicate Detection, Vault Safety does not display Study Product information on the Potential Matches page if the following setup exists:

• The Study Product on the Inbox Item is unblinded
• The Study Product on the matched Case is unblinded

Study Product Lifecycle States

After Inbox Item promotion, Vault Safety sets Study Product lifecycle states as follows:

Study Scenario	Product Blinding	Lifecycle State
Blinded Study with blinded Study Arms	Blinded	Blinded
	Unblinded	Unblinded
	Open	Open
Blinded Study with open Study Arms	Open	Open
Open Study with open Study Arms	Open	Open
Open Study Products	Open	Open
Unblinded Study	Blinded	Blinded
	Unblinded	Unblinded
	Open	Open

Unblinding Information

After Medical Review, Medical Reviewers may unblind Study Products if needed. Unblinding can occur when the following conditions are met:

• The Study Product has a Drug Role of Suspect, Interacting, or Drug Not Administered.
• The Study Product Placeholder field is populated.

After unblinding, unblinded records can be viewed only by users with the appropriate permissions.

Blinded and Unblinded Records

After completing the Case Unblinding task, Vault Safety retains the blinded records and, for each blinded record, creates an unblinded record. The default record detail page displays the unblinded records, but you can switch between the blinded and unblinded views.

Complete unblinding on unblinded records.

Consider the following when working with blinded and unblinded records:

• For Case Products on blinded Domestic Study Cases for Japan, when the Retrieve Reportable Case Product Registrations action is run, Vault generates Case Product Registrations based on the Blinding Type. For example, for unblinded Case Products, Vault generates unblinded Case Product Registration records only. For blinded Case Products, Vault generates blinded Case Product Registration records only.
• On Case Product Registration, Localized Case Assessment, and Localized Case Assessment Result records, the Blinded Reference field is always blank on unblinded records. This supports submitting blinded information to the PMDA when required.
• Substance and Dosage records do not exist on blinded Study Cases. During unblinding, unblinded Dosage and Substance records are created, but no blinded records are created. Therefore, the Blinded Reference ID field remains blank, instead of referencing a blinded record.
• On blinded records, you cannot enter information in blind-sensitive fields if an unblinded record exists. The exception to this rule is that you can edit the Case Product Dosage on a blinded record with an existing unblinded record, but the change will not be synced to the unblinded record.

Case-Level Roll-Ups

At the Case level, Vault Safety rolls up most evaluations based on blinded Case Assessment records. The exception is Case Blinded, which is based on the Blinded Type field across all Study Case Products. Rolling up from the blinded record ensures users without the required permission do not see unblinded information.

Roll-ups apply to the following Case-level fields:

• Case Blinded
• Case Tags (This value rolls up from the more conservative of the blinded or open record.)
• Expected (status)
• Case Expectedness
• Expedited
• Listedness (Core)
• Listedness (status)
• Relatedness

Updating Case Products

Use the Case Products section to manually add, edit, and delete Products on blinded Clinical Trial Study Cases. When the Drug Role is Suspect, Interacting, or Drug Not Administered, Vault Safety updates records as follows:

Action	Blinded Case	Unblinded Case
Add Product	Study Case Product created with Blinding Type set to Blinded.	Study Case Product created with Blinding Type set to Unblinded and a reference to the blinded record in the Blinded Reference field.
Edit Product	No change to the Blinding Type of Blinded.	No change to the Blinding Type of Unblinded or the Blinded Reference value.
Delete Product	See Deleting Case Records.	See Deleting Case Records.

Deleting Case Records

If your Admin has configured your Vault to cascade the deletion of parent records to the associated child records, Vault Safety applies the following logic to record deletion:

• Deleting unblinded records does not delete the associated blinded records
• Blinded records cannot be deleted if they are referenced on an unblinded record
• When global records are deleted, the associated localized records are also deleted

Otherwise, each related record must be deleted manually.

Expectedness Evaluations for Study Product Placeholders

If your Admin has enabled Datasheet Expectedness for Blinded Study Products, Vault generates expectedness for blinded Study Products on blinded Cases for double-blinded clinical trial Studies without Study Arms. Learn more about how to associate Datasheets with Study Product Placeholders and how Vault generates blinded and unblinded Study Product Placeholder Expectedness.

Creating Follow-Up or Merging to Current Study Cases

When creating Follow-up or merging to current Clinical Trial Study Cases through the Case Compare page, Vault generates blinded and unblinded records based on the Blinded field setting of the previous Case version as follows:

• If set to Blinded, Vault Safety generates blinded records only and sets the Blinding Type to Blinded.
• If set to Unblinded, Vault Safety generates both blinded and unblinded records as follows:
  • On the blinded record, the Blinding Type is set to Blinded.
  • On the unblinded record, the Blinding Type is set to Unblinded, and the Blinding Reference field references the blinded record.
  • The Case Product on the blinded record is set to rank 1. The unblinded version of the record is set to rank 2. For products other than the primary Product, the unblinded and blinded records share the same rank.

If the Blinding Type setting on the Inbox Item and the matched Case are different, Vault Safety generates records as follows:

• If the Inbox Item is unblinded and the matched Case is blinded, Vault Safety generates both blinded and unblinded records.
• If the Inbox Item is blinded and the matched Case is unblinded, Vault Safety retains the unblinded information from the existing unblinded records. In addition, information that is not blind-sensitive is added to the blinded records and synched to the unblinded records.

Case Compare

When promoting or merging Inbox Items to matched Cases, the Case Compare page displays blinded and unblinded records as follows:

• For blinded Cases, the blinded records are shown to all users.
• For unblinded Cases with blind protection, records with a Blinding Type of Open, Blinded, or blank are visible to all users. If at least one (1) record is set to the Blinding Type of Unblinded, those unblinded records are shown to users with permissions to view unblinded information.
• For unblinded Cases without blind protection, all users can see records with any Blinding Type.

When a matched Case includes both a blinded and unblinded version of a record, you cannot delete any part of that set on the Inbox Item to Case Compare page.

For information on how the Isolate Blinded Clinical Trial Information feature affects Case selection on the Case Version Compare page, see Case Version Compare.

Different Blinding Types

Where Blinding Type differs between an Inbox Item and a matched Case, when using the record selection drop-down on the Case Compare page, Vault Safety displays “(Type mismatch)” in the record label. Mismatched values cannot be selected.

Case Assessment Results

After promoting or merging an Inbox Item to an unblinded Case, if your organization uses the Assessment Result (Override) field, Vault Safety generates the new or updated Case Assessments as follows:

• On the blinded record, the Assessment Result field is populated and the Assessment Result (Override) field is cleared.
• On the unblinded record, if populated on the previous Case version, the Assessment Result (Override) value is populated in the Assessment Result field.

If your Admin has enabled Datasheet Expectedness for Blinded Study Products, when creating follow-ups or merging to existing Cases, if the Blinded Name on the Inbox Item doesn’t match the previous Case version, after promotion Vault regenerates all Case Assessment, Case Assessment Result, and Expectedness records to reflect the latest associated Datasheets for the new Study Product Placeholder. Vault deletes generated or overridden Case Assessments for the previous Study Product Placeholder.

Domestic Case Regeneration

If a Domestic Case was not successfully generated after promoting an Inbox Item or if you add a Localization to a global Case to convert it to a Domestic Case, you can generate the Case and all child records in a single action. On the Localized Case, go to the All Actions menu and select Re-generate Domestic Case.

In addition to generating the expected Case and child records, Vault Safety populates the Blinding Type and Blinded Reference fields.

Narratives

Depending on your Admin’s configuration, blind protection may or may not be turned on for Narrative documents for blinded Clinical Trial Study Cases by default.

If blind protection is turned on, the Case Narrative Preview does not display any sensitive information. When Narratives are generated for Follow-up Cases, the new Narrative copies the blind protection setting from the Narrative on the previous Case version.

If blind protection is turned off, any information in the Narrative document may be included in the Case Narrative Preview. When Narratives are generated for Follow-up Cases, blind protection remains off.

Regardless of blind protection, if the initial Narrative contained merge fields, the tokens are regenerated using the new information in the Follow-up Case.

How Unblinding Works with Reporting Rules and Transmissions

The following sections outline how the Clinical Trials: Isolate Blinded Product Information feature impacts masking on general and cross reports.

Vault Safety applies Safety Reporting Rules to blinded Clinical Trial Study Cases depending on your Admin’s configuration. For general information on the reporting rules, see Understand the Reporting Rules Engine.

Submissions

The Safety Rule Engine does not generate Submissions for blinded Products. When Products are unblinded, the Safety Rule Engine evaluates reporting obligations to generate Submissions.

Vault Safety populates report fields with unblinded Submission content based on the Study Content Protection field on the Partner Distribution List as follows:

Study Content Protection Setting	Data Export
Mask Unblinded Content	Both global and localized forms are generated with the global Product Placeholder Name (if it exists), or "PRIVACY" (if it does not exist). Product child records are not populated. Dosage export depends on your Admin's configuration. For more information, see Dosage Masking for Study Products.
Blank	Global forms are generated with the Product (Reported) name from the global Case. Localized forms are generated with the Product (Reported) name from the localized Case. Product child records are populated.

For general information on masking Study content, see Study Content Protection.

Distributions

When a Reporting Family is set up to generate Distributions for any Case linked to a specified Study, the Safety Rule Engine generates Distributions for blinded and unblinded Products. If a Study Case includes unblinded Products with blinded and open-label Products, the unblinded and open-label Products are eligible for reporting. If there are no unblinded Products, both blinded and open-label Products are eligible for reporting.

When a Reporting Family is set up to generate Distributions for any Case linked to a specified Product, the Safety Rule Engine generates Distributions for unblinded Products only, not for blinded Products.

How Unblinding Works with Aggregate Reports

The following sections outline how the Clinical Trials: Isolate Blinded Product Information feature impacts masking on aggregate reports.

Blinding Type

When generating Case Primary Products, Case Assessments, Case Assessment Result Causality, Vault Safety references the Blinding Type field.

For unmasked documents, Vault Safety prioritizes information based on Blinding Type as follows:

• Unblinded
• Blinded
• Open

For masked documents, Vault Safety prioritizes information based on Blinding Type as follows:

• Blinded
• Open

Regardless of document masking, if the Blinding Type field is blank, Vault Safety maps data as described in Generate Masked Aggregate Tabulations (CIOMS II, PBRER, and DSUR).

DSUR and PBRER: Cumulative Tabulation of Serious Adverse Events From Clinical Trials

This section describes how Vault Safety maps information to the Blinded column of Cumulative Tabulation of Serious Adverse Events From Clinical Trials for DSURs and PBRERs when using blinded and unblinded records. For information about how Vault Safety maps the remaining Cumulative Tabulation information, see the relevant sections in DSUR Aggregate Reports and PBRER Aggregate Reports.

Masked Reports	Unmasked Reports
The total number of adverse events with suspect blinded products. DSUR COUNT IF Case_version__v.study__v.blinded__v == Yes OR case_version__v.case_product__v.primary__v == Yes[1] AND case_version__v.case_product__v.study_product__v == Blank OR case_product__v.blinding_type__v == Blinded AND case_product__v.drug_role__v CONTAINS dsur__v.drug_roles_to_include__v PBRER COUNT IF Case_version__v.study__v.blinded__v == Yes OR case_version__v.case_product__v.primary__v == Yes[1] AND case_version__v.case_product__v.study_product__v == Blank OR case_product__v.blinding_type__v == Blinded AND case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v	The total number of adverse events with suspect unblinded products. DSUR COUNT IF case_version__v.case_product__v.primary__v == Yes[1] AND case_version__v.case_product__v.study_product__v == Blank OR case_product__v.blinding_type__v == Blinded AND case_product__v.drug_role__v CONTAINS dsur__v.drug_roles_to_include__v PBRER COUNT IF case_version__v.case_product__v.primary__v == Yes[1] AND case_version__v.case_product__v.study_product__v == Blank OR case_product__v.blinding_type__v == Blinded AND case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v
1. If the DSUR and PBRER Investigational Product Causality feature is enabled in your Vault, case_version__v.case_product__v.primary__v == Yes is omitted.

DSUR: Interval Line Listings of Serious Adverse Reactions and List of Subjects Who Died During the Reporting Period

When generating Interval Line Listings of Serious Adverse Reactions and List of Subjects Who Died During the Reporting Period tables, Vault Safety populates the Suspect Drug column as follows:

Masked Reports

Unmasked Reports

The name of the primary Case Product in the blinded record. First row (Primary Case Product): IF [case_version__v.case_product__v.primary__v = Yes AND case_version__v.case_product__v. product_type__v = Study Product AND {case_version__v.case_product__v.study_product_v = Blank OR case_product__v.blinding_type__v = Blinded}] THEN "Blinded" ELSE case_version__v.case_product__v.product_name__v where primary__v = Yes Subsequent rows (non-Primary Case Products): IF [case_version__v.case_product__v.primary__v != Yes AND case_version__v.case_product__v. product_type__v = Study Product AND {case_version_v.case_productv.study_product_v = Blank OR case_product__v.blinding_type__v = Blinded}] THEN "Blinded" ELSE case_version__v.case_product__v.product_name__v where primary__v != Yes

The name of the primary Case Product in the unblinded record. First row (Primary Case Product): IF [case_version__v.case_product__v.primary__v = Yes AND case_version__v.case_product__v. product_type__v = Study Product AND {case_version__v.case_product__v.study_product__v = Blank OR case_product__v.blinding_type__v = Blinded}] THEN "Blinded" ELSE case_version_v.case_product__v.product_name__v where primary__v = Yes Subsequent rows (non-Primary Case Products): IF [case_version__v.case_product__v.primary__v != Yes AND case_version__v.case_product__v. product_type__v = Study Product AND {case_version__v.case_product__v.study_product__v = Blank OR case_product__v.blinding_type__v = Blinded}] THEN "Blinded" ELSE case_version_v.case_productv.product_name_v where primary__v != Yes

When generating List of Subjects Who Died During the Reporting Period tables, Vault Safety populates the Daily Dose Route Formulation column as follows:

Masked Reports

Unmasked Reports

The value is "Blinded". First row (Primary Case Product): IF (case_product__v.primary__v = Yes) AND case_version__v.case_product__v. product_type__v = Study Product AND (case_version__v.case_product__v.study_product__v = Blank) THEN "Blinded" Subsequent rows (non-Primary Case Products): IF [case_version__v.case_product__v.primary__v != Yes AND case_version__v.case_product__v. product_type__v = Study Product AND case_version__v.case_product__v.study_product__v = Blank] THEN "Blinded"

Values are mapped from the Case Product > Case Product Dosage as follows: First row (Primary Case Product): IF (case_product__v.primary__v = Yes) AND case_version__v.case_product__v. product_type__v = Study Product AND {case_version__v.case_product__v.study_product__v = Blank OR case_product__v.blinding_type__v = Blinded}] THEN "Blinded" ELSE display: case_product__v.case_product_dosage__v.dose_number__v AND dose_unit__v, case_product__v.case_product_dosage__v.frequency_number__v AND frequency_unit__v Subsequent rows (non-Primary Case Products): IF [case_version__v.case_product__v.primary__v != Yes AND case_version__v.case_product__v.product_type__v = Study Product AND {case_version__v.case_product__v.study_product__v = Blank OR case_product__v.blinding_type__v = Blinded}] THEN "Blinded" ELSE display: case_product__v.case_product_dosage__v.dose_number__v AND dose_unit__v, case_product__v.case_product_dosage__v.frequency_number__v AND frequency_unit__v If there are multiple Dosages under the primary Case Product, values from each Dosage record are displayed in a line-separated list.

PADER

When generating PADER documents, Vault Safety references the Blinding Type field to populate the following data:

• Case Products
• Case Assessments
• Case Assessment Results
• Case Assessment Expectedness

Vault Safety determines the Primary Case Product as follows:

• Where blinded and unblinded records exist, the Case Primary Product is mapped from the blinded record.
• Where only blinded records exist, the Case Primary Product is mapped from that record.
• Where only unblinded or open-label records exist, the Case Primary Product is mapped from that record.

PSUR Summary Tabulation of Serious Unlisted Adverse Drug Reactions

When generating PSUR Summary Tabulation of Serious Unlisted Adverse Drug Reactions tables, Vault Safety references the Blinding Type field to populate the following data:

• Case Products
• Case Assessments
• Case Assessment Results

Vault Safety determines the Primary Case Product as follows:

• Where blinded and unblinded records exist, the Case Primary Product is mapped from the blinded record.
• Where only blinded records exist, the Case Primary Product is mapped from that record.
• Where only unblinded or open-label records exist, the Case Primary Product is mapped from that record.

CIOMS II Interval Line Listing of Adverse Drug Reactions

When generating CIOMS II Interval Line Listing of Adverse Drug Reactions tables, Vault Safety references the Blinding Type field to populate data. When generating Interval Line Listing of Adverse Drug Reactions, Vault Safety populates the Suspect Drug column as follows:

Masked Reports

Unmasked Reports

The name of the primary Case Product in the blinded record. First row (Primary Case Product): IF [case_version__v.case_product__v.primary__v = Yes AND case_version__v.case_product__v. product_type__v = Study Product AND {case_version__v.case_product__v.study_product_v = Blank OR case_product__v.blinding_type__v = Blinded}] THEN "Blinded" ELSE case_version__v.case_product__v.product_name__v where primary__v = Yes Subsequent rows (non-Primary Case Products): IF [case_version__v.case_product__v.primary__v != Yes AND case_version__v.case_product__v. product_type__v = Study Product AND {case_version_v.case_productv.study_product_v = Blank OR case_product__v.blinding_type__v = Blinded}] THEN "Blinded" ELSE case_version__v.case_product__v.product_name__v where primary__v != Yes

The name of the primary Case Product in the unblinded record. First row (Primary Case Product): IF [case_version__v.case_product__v.primary__v = Yes AND case_version__v.case_product__v. product_type__v = Study Product AND {case_version__v.case_product__v.study_product__v = Blank OR case_product__v.blinding_type__v = Blinded}] THEN "Blinded" ELSE case_version_v.case_product__v.product_name__v where primary__v = Yes Subsequent rows (non-Primary Case Products): IF [case_version__v.case_product__v.primary__v != Yes AND case_version__v.case_product__v. product_type__v = Study Product AND {case_version__v.case_product__v.study_product__v = Blank OR case_product__v.blinding_type__v = Blinded}] THEN "Blinded" ELSE case_version_v.case_productv.product_name_v where primary__v != Yes

When generating Interval Line Listing of Adverse Drug Reactions tables, Vault Safety populates the Daily Dose Route Formulation column as follows:

Masked Reports

Unmasked Reports

The value is "Blinded". First row (Primary Case Product): IF (case_product__v.primary__v = Yes) AND case_version__v.case_product__v. product_type__v = Study Product AND (case_version__v.case_product__v.study_product__v = Blank) THEN "Blinded" Subsequent rows (non-Primary Case Products): IF [case_version__v.case_product__v.primary__v != Yes AND case_version__v.case_product__v. product_type__v = Study Product AND case_version__v.case_product__v.study_product__v = Blank] THEN "Blinded"

Values are mapped from the Case Product > Case Product Dosage as follows: First row (Primary Case Product): IF (case_product__v.primary__v = Yes) AND case_version__v.case_product__v. product_type__v = Study Product AND {case_version__v.case_product__v.study_product__v = Blank OR case_product__v.blinding_type__v = Blinded}] THEN "Blinded" ELSE display: case_product__v.case_product_dosage__v.dose_number__v AND dose_unit__v, case_product__v.case_product_dosage__v.frequency_number__v AND frequency_unit__v Subsequent rows (non-Primary Case Products): IF [case_version__v.case_product__v.primary__v != Yes AND case_version__v.case_product__v.product_type__v = Study Product AND {case_version__v.case_product__v.study_product__v = Blank OR case_product__v.blinding_type__v = Blinded}] THEN "Blinded" ELSE display: case_product__v.case_product_dosage__v.dose_number__v AND dose_unit__v, case_product__v.case_product_dosage__v.frequency_number__v AND frequency_unit__v If there are multiple Dosages under the primary Case Product, values from each Dosage record are displayed in a line-separated list.