Manage Studies

View and manage Study records on the Business Admin > Studies page.

Sections in This Article

About Study Administration

Vault Safety stores all internal Study records on the Business Admin > Studies page. Add each study that your organization monitors and reports on to the Study library.

Vault Safety references Studies for many features, including the following functionality:

Functionality Relationship
E2B Import During an E2B import for a study case, the system attempts to match the study in the E2B file to Studies configured in the Study library.
Case Blinding When a Study has the Blinded field set to Yes, all Cases linked to that Study are blinded automatically.
ICSR Report Generation When the system generates ICSRs, including E2B, FDA 3500A, and CIOMS I reports, certain fields are mapped from the Study library. These fields are identified in their descriptions below.
Masked Safety Reports While not configured at the Study-level, you can configure Distributions to selectively mask sensitive information on Individual Case Safety Reports (ICSRs), such as unblinded study data.
Aggregate Reports Studies added to an aggregate report Reporting Family are used to filter Cases to include in report tabulations. Also, the product role configured on a Study Product is used to classify study products in DSUR reports.
Reporting Rules The system looks at local Study Registrations for Study Cases to generate Submissions according to reporting rules in your vault.
Watchlists You can set up Watchlists to monitor Cases linked to a Study and Study Product.
Automatic Expectedness and Listedness Set up a Study Datasheet for Vault Safety to automatically determine whether an adverse event is expected or unexpected in the Study.

Study Setup Overview

Vault Safety supports Studies with and without Study Arms. A Study Arm contains data specific to a group of study participants receiving a specific intervention or treatment, or no intervention, according to the study’s protocol.

We recommend that you set up Study Arms due to the added benefits and additional functionality. The following table compares features available to Studies with and without Study Arms:

Capabilities Study With Arms Study Without Arms
Manual Inbox Item Intake Yes No
Snapshot Study Site Reporter Yes Yes
Snapshot Multiple Case Products Yes No
Snapshot Case Product Indications Yes No
Snapshot Case Product Dosages Yes No
Configure Blinded Names Yes No
Configure Standard of Care Products Yes No
Blinded Study Product Names Yes No
Unblind an Individual Case One-step process Multi-step process per Case Product
Bulk Unblind the Study Yes No

Use the following checklists to guide you while you set up Studies in your vault.

Studies Without Study Arms

Note A Study must have Study Arms to be used to manually create Inbox Items. You cannot select Studies without Study Arms when you manually create Inbox Items.

The following checklist outlines how to set up a basic Study without Study Arms:

Studies With Study Arms

The following checklist outlines how to set up a Study with Study Arms:

Example Study Configuration With Study Arms

The following examples demonstrate a few variations of using study arms in a 52-week study for patients with Type 1 Diabetes.

The example study investigates the effects of Cholecap and Gleenomex on glycemic control, with Insulin as the Standard of Care where applicable.

Tip Vault does not support dose run-in periods. You can, however, configure multiple Study Arms to represent different dosages to simulate a run-in dosage period.

  • Example 1: Different Products in Each Study Arm

    The following diagram shows an example of an open study with different products and dosages in each arm:

    Different Products in every Arm.
    Example of Different Products in Every Arm

    The following image shows how this Study and its Study Arms would be configured in Vault Safety:

    Vault Configuration of Different Products in every Arm.
    Vault Configuration of Different Products in every Arm
  • Example 2: Blinded Product Names and Standard of Care

    The following diagram shows an example of a blinded study with blinded product names and a Standard of Care in each arm:

    Standard of Care and Blinded Product Names.
    Example of Blinded Product Names and Standard of Care

    The following image shows how this Study, its Study Arms, and Blinded Names would be configured in Vault Safety:

    Vault Configuration of Standard of Care and Blinded Product Names.
    Vault Configuration of Blinded Product Names and Standard of Care
  • Example 3: Open and Blinded Arms

    The following diagram shows an example of a blinded study with open and blinded arms:

    Open and Blinded Arms.
    Example of Open and Blinded Arms

    The following image shows how this Study and its Study Arms would be configured in Vault Safety:

    Vault Configuration of Open and Blinded Arms.
    Vault Configuration of Open and Blinded Arms
  • Example 4: Cycles with the Same Dosage

    The following diagram shows an example of an open study with multiple dosing cycles:

    Cycles with the same Dosage.
    Example of Cycles with the same Dosage

    The following image shows how this Study and its Study Arms would be configured in Vault Safety:

    Vault Configuration of Cycles with the same Dosage.
    Vault Configuration of Cycles with the same Dosage

Add a Study

Add a Study for each study that your organization monitors and reports on. Here

  1. Go to Business Admin > Studies.
  2. Select Create.
  3. Complete the fields on the Create Study page.
  4. Select Save.

Study Details Fields

Field Description
Study Number
(name__v)

Enter the sponsor study number. Vault Safety references the study using the number that you enter in this field.

The system snapshots this field to Cases linked to this Study and uses the Study Number to generate Case Names.

This field is also used in E2B, DSUR, and FDA 3500A report generation.

Development Phase
(development_phase__v)

For Studies reportable to the PMDA (Japan), select the development phase. While Vault Safety does not currently export to PMDA E2B R3, this field corresponds to data element J2.13.r.3

If this field does not appear on the page layout, an administrator can add it as part of the steps to enable PMDA (Japan) fields.

Study Type
(study_type__v)

Select the reason the patient was administered the Study Product. The following options are available, but your vault may be configured with additional options:

  • Clinical Trial: This option corresponds to E2B code 1 for data element C.5.4.
  • Individual Patient Use: For example, compassionate use, named patient basis. This option corresponds to E2B code 2 for data element C.5.4.
  • Other Study: For example, pharmacoepidemiology, pharmacoeconomics, intensive monitoring. This option corresponds to E2B code 3 for data element C.5.4.

The system snapshots this field to Cases linked to this Study.

This field is used to define postmarket studies for PADER, PBRER, PSUR, CIOMS I, and FDA MedWatch 3500A reports. This field is also used in E2B report generation.

If this field does not appear on the page layout, an administrator can add it as part of the steps to enable post market studies.

Masking
(masking__v)

(Required) Select the masking level required for the study.

When this field is set to Double-Blind, you can use the Blinded field to enable blind protection.

Start Date
(start_date__v)

Enter the start date for the study.

This field is for reference only.

Completion Date
(completion_date__v)

Enter the completion date for the study.

This field is for reference only.

Study Name
(study_name__v)

Enter the study name as registered in the jurisdiction where you will submit case reports.

The system snapshots this field to Cases linked to this Study.

This field is also used in E2B report generation.

Organization
(organization__v)

Select the Organization that sponsors the study.

When selecting the Study on a Case, the Case must be associated with this organization to allow users to select this study.

MedDRA Version
(meddra_version__v)

Select the MedDRA version for the study.

This field is for reference only.

Note This field does not control the MedDRA Version used by Cases associated with the Study.

Download Dosage to Case
(download_dosage_to_case__v)

This field only appears when the following conditions are true on the Study record:

  1. Blinded is set to Yes
  2. Study Has Arms is set to Yes

Select one of the following options to control how the system will snapshot Study Arm Product Dosage information to Cases involving the Study:

  • When Case is Opened: Dosage information will be populated upon case promotion.
  • When Case is Unblinded: (Default) Dosage information will be populated once the Case has been unblinded.
  • Never: The system will not snapshot Study Arm Product Dosage information to Cases.
Blinded
(blinded__v)
This field appears when you set the Masking field to Double-blind. The following list outlines how to set this field:
  • Blank: Leave this field blank when the study is not a double-blind study (single-blind or open).

  • Yes: Select this option when the study is a double-blind study that is still in progress. When you select Yes, the system applies blind protection to this Study and its Cases.
    Blind protection is activated after unblinding for Case products and associated assessments.

  • No: Select this option when the study is double-blind study that has been unblinded at the study completion.

Study Has Arms
(study_has_arms__v)
Select Yes if the study has arms. Once you save the Study, you can add Study Arms. Select No if the study does not have arms.
Study Has Unspecified Products
(study_has_unspecified_products__v)
Select this checkbox if you want to create a Study with Unspecified Products.

This option is mostly for organized data collection of reports from non-clinical trial studies. For example, for Patient Support Programs (PSPs) and Market Research Programs (MRPs) that may not have Study information available, such as Study Products or Study Product Registrations.

If you select this option, the system uses Product Registrations when evaluating reporting obligations for Cases involving this Study.

The system can not save the Study if you select this checkbox for a Study that has Study Products, Study Arms, or Registrations.

Note If you do not see this checkbox, you must add it to the Study page layout.

Core Datasheet
(datasheet__v)

Select the Core Datasheet for the Study.

Datasheets are used to automatically detect expectedness for an adverse event reported for a Study.

API Name
(api_name__v)

Enter a unique identifier that can be used with the Safety Rule "Study" parameter to define a specific Study for a reporting rule.

To learn more, see Reporting Rule Parameter Reference.

Create a Study with Unspecified Products

You can create Study placeholders for when study information is not available and has Unspecified Products. An Unspecified Product indicates there are no Study Arms, Study Products, or Study Product Registrations.

  1. Go to Business Admin > Studies.
  2. Select Create.
  3. Use the Study Details Fields table to complete the fields on the Create Study page.
    You must select the Study Has Unspecified Products checkbox.

    Note If you do not see this checkbox, you must add it to the Study page layout.

Note You can not save the Study placeholder if you set the Study Has Arms field or the Blinded field to Yes.

(Optional) Study Submission Rules Fields

To override reporting rule due dates for Cases linked to this Study, you can specify custom reporting rule timelines. When the system calculates due dates for Cases linked to this Study, the due dates follow the Submission Rule Override settings.

Field Description
Due Date Override
(fda_due_date_override__v)
To override the Due in Days parameter on reporting rules evaluated for Cases associated with this Study, select Yes.
7 Day Override
(fda_7_day_override__v)

To override the Due in Days parameter on reporting rules due in 7 days, enter the number of days in which reports are due.

This setting overrides the following FDA and EMA reporting rules:

Agency Rules
FDA
  • SUSAR (Death)
  • SUSAR (Life Threatening)
EMA
  • SUSAR (Death)
  • SUSAR (Life Threatening)
15 Day Override
(fda_15_day_override__v)

To override the Due in Days parameter on reporting rules due in 15 days, enter the number of days in which reports are due.

This setting overrides the following FDA and EMA reporting rules:

Agency Rules
FDA
  • Downgrade Serious Unexpected to Serious Expected
  • Downgrade Serious Unexpected to Non-Serious
  • Downgrade SUSAR to SAE
  • Downgrade SUSAR to Non-Serious
  • Serious Unexpected
  • SUSAR
EMA
  • Downgrade Serious to Non-Serious
  • Downgrade SUSAR to SAE
  • Downgrade SUSAR to Non-Serious
  • Serious
  • SUSAR

Add Study Products

Note You must add the Product to the product library before you can add a Study Product.

  1. Go to the Study to which you want to add the Study Product.
    Find Study records on the Business Admin > Studies page.
  2. Under Study Products, select Create.
  3. In the Create Study Product window, select the product type, and then select Continue.
    Select the same product type that the Product record is set to.
  4. Complete the fields on the Create Study Product page and select Save.

Study Product Fields

Field Description
Organization
(organization__v)

The system automatically populates this field with the Organization the Study is associated with. Products must be linked to the same Organization to be selected on the Study Product.

Study
(study__v)
The system automatically populates this field with the parent Study record.
Name
(name__v)
Enter a name to identify the Study Product. The name should be consistent with the relevant Product Registration.
Study Product Role
(study_product_role__v)

Select the role of the product in the study. If you leave this field blank, Investigational is used by default.

The following standard options are available:

  • Investigational (Default)
  • Active Comparator
  • Placebo
  • Device
  • Diagnostic
  • Standard of Care

This field is used to classify products in DSUR report generation.

Product
(product__v)
Select the Product from the product library. Start typing the name of the product to live search the product library.
Product Registration
(product_registration__v)

Select the Product Registration associated with this Study Product. The list of records is filtered by the Product selected in the Product field.

Dose
(dose_number__v | dose_unit__v | dose_unit_text__v)

Enter the amount of product that is administered in each dose. In the first field, enter a numeric value. In the second field, select a unit of measurement from the picklist or enter a custom unit.

When a blinded Study Arm Product references this Study Product, the system snapshots this field to Cases in accordance with the Download Dosage to Case setting on the Study.

Frequency
(frequency__v)

Enter a numeric value specifying the frequency of the administered dose.

When a blinded Study Arm Product references this Study Product, the system snapshots this field to Cases in accordance with the Download Dosage to Case setting on the Study.

Frequency (unit)
(frequency_unit__v)

Select the unit of measurement specifying the frequency of the administered dose.

When a blinded Study Arm Product references this Study Product, the system snapshots this field to Cases in accordance with the Download Dosage to Case setting on the Study.

Dose Form
(dose_form__v | dose_form_text__v)

Select the pharmaceutical dose form of the product from the picklist, or use a custom entry.

Vault Safety supports a selection of dose form terms, including terms from the Extended Eudravigilance Medicinal Product Dictionary (xEVMPD) and the Medicines and Healthcare products Regulatory Agency (MHRA).

For open-label and single-blinded Studies and Study Arms, the system snapshots this field to Cases upon Case promotion.

When a blinded Study Arm Product references this Study Product, the system snapshots this field to Cases in accordance with the Download Dosage to Case setting on the Study.

RoA
(roa__v | roa_text__v)

Select the route of administration of the product from the picklist or enter a custom entry.

For open-label and single-blinded Studies and Study Arms, the system snapshots this field to Cases upon Case promotion.

When a blinded Study Arm Product references this Study Product, the system snapshots this field to Cases in accordance with the Download Dosage to Case setting on the Study.

Dosage Notes
(dosage_notes__v)

(Optional) Enter any additional notes about the dose.

This field is for reference only.

Set Up Study Arms

For both open-label and blinded studies, you can configure study arms and their respective products. During intake, users can select the appropriate study arm by selecting an open arm or indicating that the patient is in one of the blinded arms.

The system snapshots data from a Study Arm to create Study Products, Dosages, and Indications under Cases linked to a Study Arm. You can configure when the system will snapshot Dosage information using the Download Dosage to Case field.

Note To add Study Arms, you must set the Study Has Arms field to Yes on the parent Study.

The following video explains enabling and using study arms in further detail:

Study Arm Prerequisites

Before you can set up study arm records, ensure that the study arms feature is fully configured in your environment.

Considerations

When setting up study arms, keep the following considerations in mind:

  • Study arms can be set up on a per-study basis.
  • Open-label studies can only have open arms, while blinded studies can have both open and blinded arms.
  • Patients in each arm can receive the same or different products and dosages.
  • Different open arms can be configured with different indications.
  • Studies with dosing cycles are supported by this feature when cycles involve the same dosages and some variation in frequency.

Add a Study Arm

  1. Go to the Study to which you want to add the Study Arm.
    Find Study records on the Business Admin > Studies page.
  2. Under Study Arms, select Create. The Create Study Arm window appears.
  3. Complete the fields on the Create Study Arm window.
  4. Select Save.

Study Arm Fields

Field Description
Organization
(organization__v)

The system automatically populates this field with the Organization the parent Study is associated with.

Study
(study__v)
The system automatically populates this field with the parent Study record.
Name
(name__v)
Enter a name to identify the Study Arm. Vault Safety references the Study Arm using the name that you enter in this field.
Blinded
(blinded__v)

This field only appears when the Blinded field is set to Yes on the parent Study. You cannot configure blinded Study Arms on open-label or single-blinded Studies.

Select one of the following options:

  • If this arm requires blind protection, select Yes. The system applies blind protection to Cases and Study Products linked to this Study Arm.
  • If this arm does not require blind protection, select No.
Indication
(indication_meddra__v)

Enter the reported term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.

To learn more, see Code MedDRA Terms.

The system snapshots this field to create a Case Product Indication under the Study Products for this Study Arm. For blinded Study Arms, the indication will be snapshot according to the Download Dosage to Case option.

Description
(description__v)

Enter a description for the Study Arm.

This field is for reference only.

Add a Study Arm Product

Once you have added a Study Arm, you can add Study Arm Products. When a Study Arm is selected on a Case, the system snapshots each Study Arm Product to automatically generate Case Products.

Note You must add the Study Product to the Study before you can add a Study Arm Product.

  1. Go to the Study to which you want to add the Study Arm Product.
    Find Study records on the Business Admin > Studies page.
  2. Under Study Arm Products, select Create.
  3. Complete the fields on the Create Study Arm Product window, and then select Save.

Study Arm Product Fields

Field Description
Organization
(organization__v)
The system automatically populates this field with the Organization the parent Study is associated with.
Study Arm
(study_arm__v)
If you add the Study Arm Product under a Study Arm, the system automatically populates this field with the parent Study Arm record. Otherwise, select the Study Arm.
Study Product
(study_product__v)
Select the Study Product for this arm from the drop-down list.
Name
(name__v)
Enter a name to identify the Study Arm Product. Vault Safety references the Study Arm using the name that you enter in this field.
Dose
(dose_number__v | dose_unit__v | dose_unit_text__v)

Enter the amount of product that is administered in each dose.
In the first field, enter a numeric value. In the second field, select a unit of measurement from the picklist or enter a custom unit.

For open Study Arms, the system snapshots this field to Cases upon Case promotion.

This field is hidden for blinded Study Arms. Instead, the system snapshots the Dose from the referenced Study Product.

Frequency
(frequency__v)

Enter a numeric value specifying the frequency of the administered dose.

For open Study Arms, the system snapshots this field to Cases upon Case promotion.

This field is hidden for blinded Study Arms. Instead, the system snapshots the Frequency from the referenced Study Product.

Frequency (unit)
(frequency_unit__v)

Select the unit of measurement specifying the frequency of the administered dose.

For open Study Arms, the system snapshots this field to Cases upon Case promotion.

This field is hidden for blinded Study Arms. Instead, the system snapshots the Frequency (unit) from the referenced Study Product.

Blinded Name
(study_product_placeholder__v)

This field is hidden for open Study Arms.

You can use this field to specify a Blinded Name to assign descriptive Case Product names while still protecting the blind.

To specify a blinded name for this product, perform one of the following actions:

  • If a blinded name (Study Product Placeholder) has already been added, select the record from the list or select the binoculars to open the browser.
  • If a blinded name has not been added, create one:
    1. Click into the field, and then select Create Study Product Placeholder from the drop-down.
    2. In the Create Study Product Placeholder window, enter the blinded name in the Name field.
    3. Select Save.

Blinded Names in Study Arms

You can set up blinded product names for Study Arm Products using the Study Product Placeholder object. When a Blinded Name is specified, the system can generate descriptive Case Product names while maintaining the blinded nature of a Study.

When patients are administered an investigational product in one study arm and a placebo in another study arm, you can specify a single Blinded Name for both of these Study Arm Products such as “Investigational vs. Placebo.” When you open a Case associated with this Study Arm, a Study Product will be added named Investigational vs. Placebo, keeping the product blinded but identifiable.

You can also assign a generic blinded name to the Standard of Care product being administered in both arms.

Note Blinded names are only used to generate Case Product names for blinded Study Arms. Each product should have the same blinded name as its counterpart (investigational or placebo) in another arm.

The following video explains enabling and using blinded names in further detail:

Refer to the diagram below for a visual representation of this example, where Cholecap and Gleenomex are investigational products, and Insulin is the Standard of Care:

Example of Blinded Study Arm Products
Example of Blinded Study Arm Products

How Dosage is Downloaded to a Case

The dosage information that is automatically downloaded to a Case depends on the blinding settings on the Study.

For Cases with blinded Study Arms, you can set the Download Dosage to Case field to automatically download information about Dosage information from a Study to the Case at the appropriate time.

Open-Label and Single-Blinded Studies

For Open-Label and Blinded Studies the following fields are automatically downloaded to a Case from the Study Product record:

  • Dose Form
  • RoA

The following fields are automatically downloaded to a Case from the Study Arm Product record:

  • Dose
  • Dose (unit)
  • Frequency
  • Frequency (unit)
Study Products and Study Arm Products on a Open-Label Studies.
Study Products and Study Arm Products on a Open-Label Studies.

Double-Blinded Studies

For Double-Blinded studies, the following fields are retrieved from the Study Product record associated with the Study Arm selected during unblinding:

  • Dose
  • Dose (unit)
  • Frequency
  • Frequency (unit)
  • Dose Form
  • RoA
Study Products on a Double-Blind Study.
Study Products on a Double-Blind Study.

Add a Study Registration

Add a Study Registration for each country the study is registered in.

When a Case Report Type is Study, the system looks at the Study Registration Countries to generate Submissions according to reporting rules in your vault. Understand the Reporting Rules Engine provides more information.

  1. Go to the Study record page.
    Find Study records on the Business Admin > Studies page.
  2. Under Registrations, select Create.
  3. Complete the fields on the Create Study Registration page.
  4. Select Save.

Study Registration Fields

Field Description
Organization
(organization__v)

The system automatically populates this field with a reference link to the Organization on the Product parent record.

The system snapshots this field to the Registration Holder field on a Case Product.

Study
(study__v)
The system automatically populates this field with a reference link to the Study parent record.
Registration Number
(registration_number__v)

Enter the study identifier assigned by the registry.

Country
(country__v)

(Required) Select the country where the product is registered and authorized.

Reporting Organization
(reporting_organization__v)

This field may also be named MAH depending on your vault's configuration.

If you have a Marketing Authorization Holder (MAH) that manages your ICSR reporting obligations for this registration, select the Organization. Selecting an Organization in this field creates an MAH Distribution List, and thereby a reporting obligation, for this registration.

Warning Use caution when setting this field. Reporting Obligations are for Distributions only and override agency submission rules. Do not select an Agency such as the FDA or EMA.

Transmission Profile
(transmission_profile__v)

To specify the Transmission Profile the system should use when automatically generating Submissions for this registration, select the Transmission Profile. We recommend setting this field when you have a Transmission Profile corresponding to this reporting destination and report type.

Transmission Product Type
(transmission_product_type__v)

Select the product type for this registration.

The system snapshots this field when generating Transmissions for this registration, then uses that value to determine whether Device-type Combination Product Constituents are exported in E2B transmissions.

See Exclude Device Constituents from E2B Exports for more information.

This field does not appear on page layouts by default, but can be added to Transmission page layouts by an administrator.

Set Up Study Site Reporters

You can configure study contacts across your study sites to be entered as site reporters during AER intake of study cases.

Configuring a study site reporter enables more efficient and accurate entry of the reporter details for a Case. Upon Case promotion, the selected reporter and their study site is used to auto-generate the primary Reporter-type Case Contact, including name, address, and contact information.

Note Snapshotting study site reporters is not currently supported for Inbox Items.

To set up study site reporters, you must first add a Study Site, and then add Study Persons under the site.

Prerequisite

Ensure that your vault has the Study Site Reporter feature enabled.

Add a Study Site

For multisite clinical studies, create a Study Site record for each site. Study Sites are linked with Site-type Organization records.

  1. Go to the Study to which you want to add a Study Site.
    Find Study records on the Business Admin > Studies page.
  2. Under Study Sites, select Create. The Create Study Site page appears.
  3. Complete the fields on the Create Study Site page.
  4. Select Save.

Study Site Fields

Field Description
Organization
(organization__v)

The system automatically populates this field with a reference link to the Organization on the Product parent record.

The system snapshots this field to the Registration Holder field on a Case Product.

Study
(study__v)
The system automatically populates this field with a reference link to the Study parent record.
Study Site Number
(name__v)
Select the Study Site with which this Study Person should be associated. When performing intake, users must select this Study Site to be able to select this Study Person on an AER.
Registration
(registration__v)
Select the Study Registration associated with this Study Site.
Site
(site__v)

To specify the site, perform one of the following actions:

  • If the Site-type Organization has already been added, select the record from the list or select the binoculars to open the browser.
  • If a Site-type Organization has not been added, create one:
    1. Click into the field, and then select Create Organization from the drop-down.
    2. In the Create Organization window, select Site as the Organization Type, and then select Continue.
    3. In the Create Site window, enter the name and address of the Study Site.
    4. Select Save.

Add a Study Contact

Use the Study Person object to add study contacts for each site.

  1. Go to the Study to which you want to add a Study Contact.
    Find Study records on the Business Admin > Studies page.
  2. Under Study Contacts, select Create. The Create Study Person page appears.
  3. Complete the fields on the Create Study Person page, and then select Save.

Study Person Fields

Field Description
Organization
(organization__v)

The system automatically populates this field with a reference link to the Organization on the Product parent record.

The system snapshots this field to the Registration Holder field on a Case Product.

Study
(study__v)
The system automatically populates this field with a reference link to the Study parent record.
Study Site
(study_site__v)
Enter the identification number for the Study Site. Vault Safety references the Study Site using the ID that you enter in this field.
Person
(registration__v)

(Required) To specify the site, perform one of the following actions:

  • If the Person has already been added, select the record from the list or select the binoculars to open the browser.
  • If the Person has not been added, create one:
    1. Click into the field, and then select Create Person from the drop-down.
    2. In the Create Person window, select Study Person as the Person Type, and then select Continue.
    3. In the Create Study Person window, enter the name and contact information.
    4. Select Save.

When this contact is selected on an AER during intake, the system snapshots the pre-configured contact information on the Study Person to generate a Reporter-type Case Contact upon Case promotion.

Name
(name__v)

(Required) Enter a name to identify the Study Person. Vault Safety references the Study Person using the name that you enter in this field.

Add a Study Indication

Tip For Studies with Study Arms, you can code the Indication at the Study Arm level instead, which the system can snapshot to Case Products.

Add a Study Indication to code the MedDRA term for the medical condition relevant to the study.

  1. Go to the Study record page.
    Find Study records on the Business Admin > Studies page.
  2. Under Indications, select Create.
  3. Specify the Indication on the Create Study Indication page.
  4. Select Save.

Study Indication Field

Field Description
Indication
(indication_meddra__v)

Enter the reported term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.

To learn more, see Code MedDRA Terms.

Mark Study for End of Study Reconciliation

At the end of a study, change the Study record state to End of Study Reconciliation to indicate that you can reconcile medical coding.

For example, if a long–term study uses multiple versions of the MedDRA dictionary, reconcile the coding to use a consistent dictionary version across the study Cases.

If your Study is blinded, you can Bulk Unblind the Study, which will change the record state to End of Study Reconciliation automatically.

Refer to your organization’s standard operating procedures for information about end of study reconciliation.

Manually Mark Study for End of Study Reconciliation

  1. Go to Business Admin > Studies.
    The Studies page appears.
  2. Select the study number for the study that you want to unblind.
    The Study:{number} page appears.
  3. From the All Actions (All Actions) menu, select Change State to End of Study Reconciliation.

Result

The Study record enters the End of Study Reconciliation lifecycle state.


Manage Combination Products
Bulk Unblind a Study
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