Sections in This Article
About Study Administration
Vault Safety stores all internal Study records on the Business Admin > Objects > 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:
- Add a Study
- Add Study Products
- Add Study Registrations
- (Optional) Add Study Site and Study Site Reporters
- (Optional) Add Study Indication
Studies With Study Arms
The following checklist outlines how to set up a Study with Study Arms:
- Add a Study
- Add Study Products
- Add Study Arms
- Add Study Arm Products
- Add Study Registrations
- (Optional) Add Study Site and Study Site Reporters
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:
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 - 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:
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 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:
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 - Example 4: Cycles with the Same Dosage
The following diagram shows an example of an open study with multiple dosing cycles:
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
Add a Study
Add a Study for each study that your organization monitors and reports on. Here
- Go to Business Admin > Objects > Studies.
- Select Create.
- Complete the fields on the Create Study page.
- 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:
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. |
| Protocol Title ( protocol_title__v) |
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. |
| 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:
Select one of the following options to control how the system will snapshot Study Arm Product Dosage information to Cases involving the Study:
|
| Blinded ( blinded__v) |
This field appears when you set the Masking field to Double-blind. The following list outlines how to set this field:
|
| 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.
- Go to Business Admin > Objects > Studies.
- Select Create.
- 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:
|
||||||
| 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:
|
Add Study Products
Note You must add the Product to the product library before you can add a Study Product.
- Go to the Study to which you want to add the Study Product.
Find Study records on the Business Admin > Objects > Studies page. - Under Study Products, select Create.
- 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. - 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:
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. |
| Market Segment ( market_segment__v) |
Select a Market Segment from the picklist. This field does not appear on page layouts by default. Depending on your organization’s security configuration, it may be added by your Admin. |
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
- Go to the Study to which you want to add the Study Arm.
Find Study records on the Business Admin > Objects > Studies page. - Under Study Arms, select Create. The Create Study Arm window appears.
- Complete the fields on the Create Study Arm window.
- 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:
|
| 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.
- Go to the Study to which you want to add the Study Arm Product.
Find Study records on the Business Admin > Objects > Studies page. - Under Study Arm Products, select Create.
- 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. 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:
|
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.
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)
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
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.
- Go to the Study record page.
Find Study records on the Business Admin > Objects > Studies page. - Under Registrations, select Create.
- Complete the fields on the Create Study Registration page.
- 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. |
| Registration Type ( registration_type__v) |
Select the registration type. This field is used in report generation for FDA MedWatch 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. |
| 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.
- Go to the Study to which you want to add a Study Site.
Find Study records on the Business Admin > Objects > Studies page. - Under Study Sites, select Create. The Create Study Site page appears.
- Complete the fields on the Create Study Site page.
- 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:
|
Add a Study Contact
Use the Study Person object to add study contacts for each site.
- Go to the Study to which you want to add a Study Contact.
Find Study records on the Business Admin > Objects > Studies page. - Under Study Contacts, select Create. The Create Study Person page appears.
- 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:
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.
- Go to the Study record page.
Find Study records on the Business Admin > Objects > Studies page. - Under Indications, select Create.
- Specify the Indication on the Create Study Indication page.
- 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
- Go to Business Admin > Objects > Studies.
The Studies page appears. - Select the study number for the study that you want to unblind.
The Study:{number} page appears. - From the All Actions (
) menu, select Change State to End of Study Reconciliation.
Result
The Study record enters the End of Study Reconciliation lifecycle state.
