Manage Studies

Set up a Study Datasheet for Vault Safety to automatically determine whether an adverse event is expected or unexpected in the Study. For Studies that include multiple Products, you can set up Study Product Datasheets.

In Vaults configured to isolate blinded clinical trial information, Vault can generate expectedness for blinded Study Products on blinded Cases. This requires you to associate Datasheets with Study Product Placeholders.

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

Vault maps 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.

For Studies reportable to the PMDA (Japan), select the development phase.

For more information on fields for Japan-based Studies, see Add Japan Study Information in Set Up the Localized Business Admin Library for Japan.

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.

Vault maps this field to Cases linked to this Study.

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

If this field does not appear, your Admin can add it as part of the steps to enable post market studies.

(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.

Depending on your Admin's configuration, this field may have a different name.

Enter the start date for the study.

This field is for reference only.

Enter the completion date for the study.

This field is for reference only.

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

Vault maps this field to Cases linked to this Study.

This field is also used in E2B report generation.

This field is used by organizations with a Vault Clinical Operations to Vault Safety Connection. When Study records are created or edited in the Clinical Operations Vault, values in the Protocol Title field are applied to the associated Study records in Vault Safety.

In Vault Safety, this field is for reference only.

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.

Select the MedDRA version for the study.

This field is for reference only.

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 Vault will map 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: Vault will not map Study Arm Product Dosage information to Cases.

Select whether the study is Open Label, Unblinded, or Blinded.

When you select Blinded, Vault applies blind protection to this Study and its Cases. Blind protection is activated after unblinding for Case Products and associated assessments.

Depending on your Admin's configuration, the Blinded field on Studies may be named "Blinding Type".

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.

When creating Clinical Trial Studies, if your Admin has configured your Vault to isolate blinded Product information, we recommend selecting No.

You cannot change this field from No to Yes if there are any Datasheets associated with a Study Product Placeholder on the Study. You must first remove any Datasheets from the applicable Study Product Placeholder record and then update this field to Yes.

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, Vault uses Product Registrations when evaluating reporting obligations for Cases involving this Study.

Vault cannot save the Study if you select this checkbox for a Study that has Study Products, Study Arms, or Registrations.

Select the Core Datasheet for the Study.

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

If selected, Vault evaluates reporting for the Study as follows:

• If the Study has one or more registrations, Vault evaluates the Study for general reporting only for each registration. Vault does not evaluate the Study for cross reporting.
• If the Study has no registrations, Vault does not evaluate the Study for either general reporting or cross reporting.

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.

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:

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:

Vault 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.

Select the role of the product in the study. If you leave this field blank, Investigational is used by default. This field is used to classify products in DSUR report generation.

If you selected Auxiliary for the Study Product Role, specify whether the AxMP is Authorized or Not Authorized.

To learn more about using the Auxiliary Medicinal Product Status in Safety Rules, see the Reporting Rule Parameter Reference.

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

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, select an existing record or create a new record by selecting Create Study Product Placeholder.

This field is hidden for open Study Arms.

For Studies with multiple products, you can add Study Product-specific Investigator Brochures.

Select from existing Datasheets, or create a new Datasheet.

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 use a custom entry.

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

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

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

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

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

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, Vault maps this field to Cases upon Case promotion.

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

Select the Route of Administration of the product from the picklist or use a custom entry.

For open-label and single-blinded Studies and Study Arms, Vault maps this field to Cases upon Case promotion.

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

(Optional) Enter any additional notes about the dose.

This field is for reference only.

Select a Market Segment from the picklist.

This field does not appear on layouts by default. Depending on your organization's security configuration, it may be added by your Admin.

Enter the Clinical Trial Application approval number. This field is used for clinical trial study Case submissions to the NMPA.

Vault exports this value to the G.k.CN.4 Approval Number/ Acceptance Number 批准文号/受理号 data element of NMPA E2B(R3) files.

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

This field appears when the parent Study Blinded field is set to Blinded.

If this arm requires blind protection, select Blinded. Vault applies blind protection to Cases and Study Products linked to this Study Arm.

If this arm does not require blind protection, select Open Label or Unblinded, as applicable.

Depending on your Admin's configuration, the Blinded field on Study Arms may be named "Masking".

Enter the Study Arm Indication at the LLT or PT level in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the Advanced Search () icon to open the MedDRA browser.

To learn more, see Code MedDRA Terms.

Vault maps this field to create a Case Product Indication under the Study Products for this Study Arm. For blinded Study Arms, the indication maps according to the Download Dosage to Case option.

Enter a description for the Study Arm.

This field is for reference only.

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, Vault maps this field to Cases upon Case promotion.

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

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

For open Study Arms, Vault maps this field to Cases upon Case promotion.

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

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

For open Study Arms, Vault maps this field to Cases upon Case promotion.

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

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. For blinded Products in blinded Study Arms, you can also specify the primary blinded investigational Product, which Vault uses to calculate reportability to the PMDA.

To specify a blinded name or the primary blinded investigational Product for a Product, perform one (1) the following actions:

• If the blinded name (Study Product Placeholder) exists, select it from the dropdown list or select Advanced Search () to search for the Study Product Placeholder. After making your selection, click Close.
  • If needed, add a Primary Blinded Investigational Product to the Study Product Placeholder record. For more information, see Set Up the Localized Business Admin Library for Japan.
• If the blinded name (Study Product Placeholder) does not exist, select Create Study Product Placeholder and complete the following steps:
  1. In the Create Study Product Placeholder dialog, enter the blinded name in the Name field.
  2. Optional: In the Primary Blinded Investigational Product field, select a Product. For more information on this field, see Blinded Study Product Reporting in Report to the PMDA.
  3. Select Save.

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

Vault maps this field to the Registration Holder field on a Case Product.

Enter the study identifier assigned by the registry.

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

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.

Select the registration type.

This field is used in report generation for FDA 3500A and PADER formats.

This field is needed to correctly match Transmission Profile Scope records for any Organization which has multiple Transmission Profiles for the same destination Agency.

To specify the Transmission Profile Vault 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.

Select the product type for this registration.

Vault maps 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 layouts by default, but can be added to Transmission layouts by an administrator.

Enter the Japanese Clinical Compound Number (CCN) of the investigational drug. This field appears only if the Country field is set to Japan.

For more information on fields for Japan-based Studies, see Add Japan Study Information in Set Up the Localized Business Admin Library for Japan.

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

Vault maps this field to the Registration Holder field on a Case Product.

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.

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

Vault maps this field to the Registration Holder field on a Case Product.

(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, contact information, and language.
  4. Select Save.

When this contact is selected on an Inbox Item (if enabled by Veeva Support and your Admin) during intake, Vault maps the pre-configured contact information on the Study Person to generate a Reporter-type Case Contact upon Case promotion.

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

Enter the Study Indication at the LLT or PT level in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the Advanced Search () icon to open the MedDRA browser.

To learn more, see Code MedDRA Terms.

Select the Study Registration for this Study Product Country record.

When evaluating this Study Registration for General Reporting, Vault considers only those Case Products that are of object type Study Product that are linked with a Study Product record with an associated Study Product Country record as eligible for evaluation for that registration agency regardless of Study Product Role.

When evaluating this Study Registration for Marketing-to-Investigational (M>I) and Investigational-to-Investigational (I>I) cross reporting, Vault follows the standard cross reporting logic to find potentially cross reportable products. Using that Product, Vault finds any Product Registration linked to that Product by Study Product Country where the Study Product Role is Investigational or Comparator. Vault then looks for any Study Registrations that do not have an associated Study Product Country. Vault then evaluates the rule for the respective registrations.

Select the Study Product Role that applies to this Study Product Country record. Any value you select here overrides the Study Product Role on the Study Product.

Specify if the Auxiliary Medicinal Product (AxMP) is authorized, if applicable.